Churg-Strauss Syndrome
Conditions
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
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.
Placebo will be available as 0.9% sodium chloride
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants in Each Category of Accrued Duration of Remission | Up to Week 52 | 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. |
| Number of Participants Who Are in Remission at 36 and 48 Weeks | Week 36 and Week 48 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First EGPA Relapse | Up to Week 52 | 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. |
| 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 Week52 | 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. |
| Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | Up to Week 52 | 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. |
| Number of Participants in Each Category of Accrued Duration of Remission | Up to Week 52 | 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. |
| Number of Participants Who Are in Remission at 36 and 48 Weeks | Week 36 and Week 48 | 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. |
| 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 | Up to Week 52 | 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. |
| Number of Participants With Local and Systemic Adverse Events (AEs) | Up to Week 52 | 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. |
| 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 | Baseline and up to Week 60 | 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. |
| Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Baseline and up to Week 60 | 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. |
| Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Baseline and up to Week 60 | 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. |
| 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 | Baseline and up to Week 60 | 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. |
| Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Baseline and up to Week 60 | 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. |
| Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Baseline and up to Week 60 | 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. |
| Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Baseline and up to Week 60 | 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. |
| Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Baseline and up to Week 60 | 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. |
| Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Baseline and up to Week 60 | 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. |
| Change From Baseline in Hematology Parameters of Erythrocytes Levels | Baseline and up to Week 60 | 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. |
| Number of Participants With Anti-Mepolizumab Antibodies | Up to Week 60 | 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. |
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | Baseline up to Week 60 | 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. |
| Change From Baseline in Pulse Rate | Baseline and up to Week 60 | 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. |
| Change From Baseline in Body Temperature | Baseline and up to Week 60 | 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. |
| Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | Baseline and up to Week 60 | 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). |
| Maximum Change From Baseline in QTcF and QTcB Values | Baseline and up to Week 60 | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 136 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 2 |
Baseline characteristics
| Characteristic | Mepolizumab 300mg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 48.7 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 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race customized Asian - Japanese Heritage | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Race customized Asian - South East Asian Heritage | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race customized Mixed Race | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Race customized White - Arabic/North African Heritage | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Race customized White - White/Caucasian/European Heritage | 62 Participants | 123 Participants | 61 Participants |
| Sex: Female, Male Female | 42 Participants | 80 Participants | 38 Participants |
| Sex: Female, Male Male | 26 Participants | 56 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 1 / 68 |
| other Total, other adverse events | 61 / 68 | 65 / 68 |
| serious Total, serious adverse events | 18 / 68 | 12 / 68 |
Outcome results
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | >0 to <12 weeks | 8 Participants |
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | 24 to <36 weeks | 0 Participants |
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | 12 to <24 weeks | 3 Participants |
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | >=36 weeks | 2 Participants |
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | Zero | 55 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | >=36 weeks | 9 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | Zero | 32 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | >0 to <12 weeks | 8 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | 12 to <24 weeks | 9 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | 24 to <36 weeks | 10 Participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Are in Remission at 36 and 48 Weeks | 2 Participants |
| Mepolizumab 300mg | Number of Participants Who Are in Remission at 36 and 48 Weeks | 22 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Body Temperature | Absolute Baseline; n= 68, 68 | 36.52 Degree celsius | Standard Deviation 0.385 |
| Placebo | Change From Baseline in Body Temperature | Week 4; n= 68, 68 | 0.05 Degree celsius | Standard Deviation 0.439 |
| Placebo | Change From Baseline in Body Temperature | Week 8; n= 67,68 | -0.01 Degree celsius | Standard Deviation 0.379 |
| Placebo | Change From Baseline in Body Temperature | Week 12; n= 66, 68 | 0.05 Degree celsius | Standard Deviation 0.41 |
| Placebo | Change From Baseline in Body Temperature | Week 16; n= 64, 68 | -0.01 Degree celsius | Standard Deviation 0.421 |
| Placebo | Change From Baseline in Body Temperature | Week 20; n= 63, 68 | -0.08 Degree celsius | Standard Deviation 0.351 |
| Placebo | Change From Baseline in Body Temperature | Week 24; n= 62, 67 | -0.06 Degree celsius | Standard Deviation 0.449 |
| Placebo | Change From Baseline in Body Temperature | Week 28; n= 63, 67 | -0.06 Degree celsius | Standard Deviation 0.499 |
| Placebo | Change From Baseline in Body Temperature | Week 32; n= 62, 67 | -0.09 Degree celsius | Standard Deviation 0.392 |
| Placebo | Change From Baseline in Body Temperature | Week 36; n= 62, 67 | -0.05 Degree celsius | Standard Deviation 0.431 |
| Placebo | Change From Baseline in Body Temperature | Week 40; n= 62, 66 | -0.03 Degree celsius | Standard Deviation 0.53 |
| Placebo | Change From Baseline in Body Temperature | Week 44; n= 61, 65 | -0.03 Degree celsius | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Body Temperature | Week 48; n= 61, 64 | -0.04 Degree celsius | Standard Deviation 0.452 |
| Placebo | Change From Baseline in Body Temperature | Week 52; n= 60, 65 | -0.04 Degree celsius | Standard Deviation 0.423 |
| Placebo | Change From Baseline in Body Temperature | Week 56; n= 61, 63 | -0.08 Degree celsius | Standard Deviation 0.53 |
| Placebo | Change From Baseline in Body Temperature | Week 60; n= 61, 64 | 0.03 Degree celsius | Standard Deviation 0.467 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 60; n= 61, 64 | -0.02 Degree celsius | Standard Deviation 0.479 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Absolute Baseline; n= 68, 68 | 36.51 Degree celsius | Standard Deviation 0.462 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 32; n= 62, 67 | -0.07 Degree celsius | Standard Deviation 0.355 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 4; n= 68, 68 | -0.04 Degree celsius | Standard Deviation 0.411 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 48; n= 61, 64 | -0.09 Degree celsius | Standard Deviation 0.414 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 8; n= 67,68 | -0.02 Degree celsius | Standard Deviation 0.425 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 36; n= 62, 67 | 0.03 Degree celsius | Standard Deviation 0.468 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 12; n= 66, 68 | -0.03 Degree celsius | Standard Deviation 0.447 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 56; n= 61, 63 | -0.00 Degree celsius | Standard Deviation 0.402 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 16; n= 64, 68 | -0.03 Degree celsius | Standard Deviation 0.432 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 40; n= 62, 66 | -0.13 Degree celsius | Standard Deviation 0.406 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 20; n= 63, 68 | -0.13 Degree celsius | Standard Deviation 0.376 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 52; n= 60, 65 | -0.12 Degree celsius | Standard Deviation 0.541 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 24; n= 62, 67 | -0.06 Degree celsius | Standard Deviation 0.389 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 44; n= 61, 65 | -0.08 Degree celsius | Standard Deviation 0.396 |
| Mepolizumab 300mg | Change From Baseline in Body Temperature | Week 28; n= 63, 67 | -0.14 Degree celsius | Standard Deviation 0.411 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | Cholesterol; Week 16; n= 1, 1 | -0.400 millimoles per liter (mmol/L) | — |
| Placebo | 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 | Calcium; Week 16; n= 65, 68 | 0.000 millimoles per liter (mmol/L) | Standard Deviation 0.1091 |
| Placebo | 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 | Calcium; Week 20; n= 63, 68 | 0.002 millimoles per liter (mmol/L) | Standard Deviation 0.0882 |
| Placebo | 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 | Calcium; Week 24; n= 63, 66 | 0.001 millimoles per liter (mmol/L) | Standard Deviation 0.0901 |
| Placebo | 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 | Calcium; Week 28; n= 61, 66 | 0.001 millimoles per liter (mmol/L) | Standard Deviation 0.0962 |
| Placebo | 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 | Calcium; Week 32; n= 61, 67 | -0.000 millimoles per liter (mmol/L) | Standard Deviation 0.0911 |
| Placebo | 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 | Calcium; Week 36; n= 60, 67 | -0.006 millimoles per liter (mmol/L) | Standard Deviation 0.0931 |
| Placebo | 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 | Calcium; Week 40; n= 61, 66 | 0.014 millimoles per liter (mmol/L) | Standard Deviation 0.1126 |
| Placebo | 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 | Calcium; Week 44; n= 61, 66 | 0.016 millimoles per liter (mmol/L) | Standard Deviation 0.1144 |
| Placebo | 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 | Calcium; Week 48; n= 61, 64 | -0.007 millimoles per liter (mmol/L) | Standard Deviation 0.1007 |
| Placebo | 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 | Calcium; Week 52; n= 60, 65 | -0.008 millimoles per liter (mmol/L) | Standard Deviation 0.1001 |
| Placebo | 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 | Calcium; Week 56; n= 61, 63 | -0.008 millimoles per liter (mmol/L) | Standard Deviation 0.0931 |
| Placebo | 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 | Calcium; Week 60; n= 60, 65 | -0.025 millimoles per liter (mmol/L) | Standard Deviation 0.0946 |
| Placebo | 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 | Absolute Chloride; Baseline; n= 68, 68 | 103.4 millimoles per liter (mmol/L) | Standard Deviation 2.05 |
| Placebo | 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 | Chloride; Week 4; n= 68, 68 | 0.6 millimoles per liter (mmol/L) | Standard Deviation 1.97 |
| Placebo | 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 | Chloride; Week 8; n= 67, 66 | 0.9 millimoles per liter (mmol/L) | Standard Deviation 2.05 |
| Placebo | 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 | Chloride; Week 12; n= 65, 68 | 0.7 millimoles per liter (mmol/L) | Standard Deviation 2.32 |
| Placebo | 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 | Chloride; Week 16; n= 65, 68 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 2.08 |
| Placebo | 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 | Chloride; Week 20; n= 63, 68 | 0.3 millimoles per liter (mmol/L) | Standard Deviation 2.38 |
| Placebo | 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 | Chloride; Week 24; n= 63, 66 | 0.6 millimoles per liter (mmol/L) | Standard Deviation 2.51 |
| Placebo | 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 | Chloride; Week 28; n= 62, 66 | 0.7 millimoles per liter (mmol/L) | Standard Deviation 2.17 |
| Placebo | 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 | Chloride; Week 32; n= 61, 67 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.24 |
| Placebo | 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 | Chloride; Week 36; n= 60, 67 | 0.8 millimoles per liter (mmol/L) | Standard Deviation 2.53 |
| Placebo | 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 | Chloride; Week 40; n= 61, 66 | 0.9 millimoles per liter (mmol/L) | Standard Deviation 2.22 |
| Placebo | 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 | Chloride; Week 44; n= 61, 66 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 2.13 |
| Placebo | 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 | Chloride; Week 48; n= 61, 64 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 2.38 |
| Placebo | 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 | Chloride; Week 52; n= 60, 65 | 0.3 millimoles per liter (mmol/L) | Standard Deviation 2.26 |
| Placebo | 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 | Chloride; Week 56; n= 61, 63 | 0.7 millimoles per liter (mmol/L) | Standard Deviation 2.27 |
| Placebo | 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 | Chloride; Week 60; n= 60, 65 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.01 |
| Placebo | 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 | Absolute Cholesterol; Baseline; n= 68, 68 | 5.771 millimoles per liter (mmol/L) | Standard Deviation 1.2033 |
| Placebo | 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 | Cholesterol; Week 8; n= 2, 0 | -0.250 millimoles per liter (mmol/L) | Standard Deviation 0.1414 |
| Placebo | 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 | Cholesterol; Week 12; n= 1, 0 | 0.050 millimoles per liter (mmol/L) | — |
| Placebo | 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 | Absolute Calcium; Baseline; n= 68, 68 | 2.365 millimoles per liter (mmol/L) | Standard Deviation 0.0864 |
| Placebo | 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 | Cholesterol; Week 20; n= 1, 1 | 0.050 millimoles per liter (mmol/L) | — |
| Placebo | 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 | Cholesterol; Week 52; n= 60, 65 | -0.006 millimoles per liter (mmol/L) | Standard Deviation 0.9364 |
| Placebo | 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 | Cholesterol; Week 56; n= 1, 0 | -0.220 millimoles per liter (mmol/L) | — |
| Placebo | 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 | Absolute Glucose; Baseline; n= 68, 68 | 5.76 millimoles per liter (mmol/L) | Standard Deviation 2 |
| Placebo | 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 | Glucose; Week 4; n= 68, 68 | 0.27 millimoles per liter (mmol/L) | Standard Deviation 1.619 |
| Placebo | 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 | Glucose; Week 8; n= 67, 66 | 0.09 millimoles per liter (mmol/L) | Standard Deviation 1.695 |
| Placebo | 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 | Glucose; Week 12; n= 65, 68 | 0.27 millimoles per liter (mmol/L) | Standard Deviation 1.961 |
| Placebo | 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 | Glucose; Week 16; n= 65, 68 | 0.03 millimoles per liter (mmol/L) | Standard Deviation 1.454 |
| Placebo | 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 | Glucose; Week 20; n= 63, 68 | 0.25 millimoles per liter (mmol/L) | Standard Deviation 1.644 |
| Placebo | 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 | Glucose; Week 24; n= 63, 66 | 0.02 millimoles per liter (mmol/L) | Standard Deviation 1.588 |
| Placebo | 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 | Glucose; Week 28; n= 62, 66 | 0.14 millimoles per liter (mmol/L) | Standard Deviation 1.613 |
| Placebo | 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 | Glucose; Week 32; n= 61, 67 | -0.03 millimoles per liter (mmol/L) | Standard Deviation 1.808 |
| Placebo | 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 | Glucose; Week 36; n= 60, 67 | 0.11 millimoles per liter (mmol/L) | Standard Deviation 1.525 |
| Placebo | 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 | Glucose; Week 40; n= 61, 66 | 0.34 millimoles per liter (mmol/L) | Standard Deviation 1.831 |
| Placebo | 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 | Glucose; Week 44; n= 61, 66 | 0.21 millimoles per liter (mmol/L) | Standard Deviation 1.766 |
| Placebo | 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 | Glucose; Week 48; n= 61, 64 | 0.32 millimoles per liter (mmol/L) | Standard Deviation 2.065 |
| Placebo | 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 | Glucose; Week 52; n= 60, 65 | -0.17 millimoles per liter (mmol/L) | Standard Deviation 1.65 |
| Placebo | 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 | Glucose; Week 56; n= 61, 63 | 0.01 millimoles per liter (mmol/L) | Standard Deviation 1.718 |
| Placebo | 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 | Glucose; Week 60; n= 60, 65 | 0.20 millimoles per liter (mmol/L) | Standard Deviation 1.664 |
| Placebo | 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 | Absolute HDL cholesterol; Baseline; n= 68, 68 | 1.837 millimoles per liter (mmol/L) | Standard Deviation 0.454 |
| Placebo | 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 | HDL cholesterol; Week 8; n= 2, 0 | -0.075 millimoles per liter (mmol/L) | Standard Deviation 0.0354 |
| Placebo | 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 | HDL cholesterol; Week 12; n= 1, 0 | -0.100 millimoles per liter (mmol/L) | — |
| Placebo | 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 | HDL cholesterol; Week 16; n= 1, 1 | 0.400 millimoles per liter (mmol/L) | — |
| Placebo | 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 | HDL cholesterol; Week 20; n= 1, 1 | 0.000 millimoles per liter (mmol/L) | — |
| Placebo | 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 | HDL cholesterol; Week 52; n= 60, 65 | -0.045 millimoles per liter (mmol/L) | Standard Deviation 0.2832 |
| Placebo | 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 | HDL cholesterol; Week 56; n= 1, 0 | -0.060 millimoles per liter (mmol/L) | — |
| Placebo | 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 | Absolute LDL cholesterol; Baseline; n= 67, 68 | 3.261 millimoles per liter (mmol/L) | Standard Deviation 1.0808 |
| Placebo | 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 | LDL cholesterol; Week 8; n= 1, 0 | -0.350 millimoles per liter (mmol/L) | — |
| Placebo | 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 | LDL cholesterol; Week 12; n= 1, 0 | 0.190 millimoles per liter (mmol/L) | — |
| Placebo | 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 | LDL cholesterol; Week 16; n= 1, 1 | -0.730 millimoles per liter (mmol/L) | — |
| Placebo | 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 | LDL cholesterol; Week 20; n= 1, 1 | -0.150 millimoles per liter (mmol/L) | — |
| Placebo | 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 | LDL cholesterol; Week 52; n= 58, 64 | 0.016 millimoles per liter (mmol/L) | Standard Deviation 0.7717 |
| Placebo | 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 | LDL cholesterol; Week 56; n= 1, 0 | 0.100 millimoles per liter (mmol/L) | — |
| Placebo | 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 | Absolute Phosphate; Baseline; n= 68, 68 | 1.068 millimoles per liter (mmol/L) | Standard Deviation 0.1797 |
| Placebo | 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 | Phosphate; Week 4; n= 68, 68 | -0.027 millimoles per liter (mmol/L) | Standard Deviation 0.2183 |
| Placebo | 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 | Phosphate; Week 8; n= 67, 66 | -0.004 millimoles per liter (mmol/L) | Standard Deviation 0.1577 |
| Placebo | 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 | Phosphate; Week 12; n= 65, 68 | 0.003 millimoles per liter (mmol/L) | Standard Deviation 0.1821 |
| Placebo | 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 | Phosphate; Week 16; n= 65, 68 | 0.016 millimoles per liter (mmol/L) | Standard Deviation 0.1819 |
| Placebo | 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 | Phosphate; Week 20; n= 63, 68 | -0.001 millimoles per liter (mmol/L) | Standard Deviation 0.1611 |
| Placebo | 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 | Phosphate; Week 24; n= 63, 66 | -0.042 millimoles per liter (mmol/L) | Standard Deviation 0.1565 |
| Placebo | 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 | Phosphate; Week 28; n= 62, 66 | -0.025 millimoles per liter (mmol/L) | Standard Deviation 0.1819 |
| Placebo | 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 | Phosphate; Week 32; n= 61, 67 | -0.018 millimoles per liter (mmol/L) | Standard Deviation 0.1975 |
| Placebo | 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 | Phosphate; Week 36; n= 60, 67 | -0.038 millimoles per liter (mmol/L) | Standard Deviation 0.2159 |
| Placebo | 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 | Phosphate; Week 40; n= 61, 66 | -0.029 millimoles per liter (mmol/L) | Standard Deviation 0.1822 |
| Placebo | 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 | Phosphate; Week 44; n= 61, 66 | -0.018 millimoles per liter (mmol/L) | Standard Deviation 0.2104 |
| Placebo | 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 | Phosphate; Week 48; n= 61, 64 | -0.053 millimoles per liter (mmol/L) | Standard Deviation 0.1931 |
| Placebo | 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 | Phosphate; Week 52; n= 60, 65 | 0.005 millimoles per liter (mmol/L) | Standard Deviation 0.1939 |
| Placebo | 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 | Phosphate; Week 56; n= 61, 63 | 0.019 millimoles per liter (mmol/L) | Standard Deviation 0.2962 |
| Placebo | 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 | Phosphate; Week 60; n= 60, 65 | -0.035 millimoles per liter (mmol/L) | Standard Deviation 0.2125 |
| Placebo | 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 | Absolute Potassium; Baseline; n= 68, 68 | 4.11 millimoles per liter (mmol/L) | Standard Deviation 0.348 |
| Placebo | 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 | Potassium; Week 4; n= 68, 68 | 0.05 millimoles per liter (mmol/L) | Standard Deviation 0.378 |
| Placebo | 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 | Potassium; Week 8; n= 67, 66 | 0.01 millimoles per liter (mmol/L) | Standard Deviation 0.309 |
| Placebo | 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 | Potassium; Week 12; n= 65, 68 | -0.04 millimoles per liter (mmol/L) | Standard Deviation 0.318 |
| Placebo | 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 | Potassium; Week 16; n= 65, 68 | 0.06 millimoles per liter (mmol/L) | Standard Deviation 0.34 |
| Placebo | 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 | Potassium; Week 20; n= 63, 68 | 0.08 millimoles per liter (mmol/L) | Standard Deviation 0.382 |
| Placebo | 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 | Potassium; Week 24; n= 63, 66 | -0.02 millimoles per liter (mmol/L) | Standard Deviation 0.298 |
| Placebo | 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 | Potassium; Week 28; n= 61, 66 | 0.07 millimoles per liter (mmol/L) | Standard Deviation 0.338 |
| Placebo | 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 | Potassium; Week 32; n= 61, 67 | 0.04 millimoles per liter (mmol/L) | Standard Deviation 0.34 |
| Placebo | 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 | Potassium; Week 36; n= 60, 67 | 0.02 millimoles per liter (mmol/L) | Standard Deviation 0.291 |
| Placebo | 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 | Potassium; Week 40; n= 61, 66 | 0.08 millimoles per liter (mmol/L) | Standard Deviation 0.419 |
| Placebo | 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 | Potassium; Week 44; n= 61, 66 | 0.08 millimoles per liter (mmol/L) | Standard Deviation 0.383 |
| Placebo | 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 | Potassium; Week 48; n= 61, 64 | 0.09 millimoles per liter (mmol/L) | Standard Deviation 0.367 |
| Placebo | 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 | Potassium; Week 52; n= 60, 65 | 0.05 millimoles per liter (mmol/L) | Standard Deviation 0.344 |
| Placebo | 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 | Potassium; Week 56; n= 61, 63 | 0.08 millimoles per liter (mmol/L) | Standard Deviation 0.379 |
| Placebo | 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 | Potassium; Week 60; n= 60, 65 | 0.00 millimoles per liter (mmol/L) | Standard Deviation 0.358 |
| Placebo | 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 | Absolute Sodium; Baseline; n= 68, 68 | 139.8 millimoles per liter (mmol/L) | Standard Deviation 2.03 |
| Placebo | 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 | Sodium; Week 4; n= 68, 68 | 0.2 millimoles per liter (mmol/L) | Standard Deviation 1.86 |
| Placebo | 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 | Sodium; Week 8; n= 67, 66 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| Placebo | 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 | Sodium; Week 12; n= 65, 68 | 0.1 millimoles per liter (mmol/L) | Standard Deviation 1.99 |
| Placebo | 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 | Sodium; Week 16; n= 65, 68 | 0.0 millimoles per liter (mmol/L) | Standard Deviation 1.46 |
| Placebo | 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 | Sodium; Week 20; n= 63, 68 | 0.0 millimoles per liter (mmol/L) | Standard Deviation 1.88 |
| Placebo | 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 | Sodium; Week 24; n= 63, 66 | 0.2 millimoles per liter (mmol/L) | Standard Deviation 1.94 |
| Placebo | 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 | Sodium; Week 28; n= 62, 66 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 1.71 |
| Placebo | 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 | Sodium; Week 32; n= 61, 67 | 0.3 millimoles per liter (mmol/L) | Standard Deviation 1.92 |
| Placebo | 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 | Sodium; Week 36; n= 60, 67 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.1 |
| Placebo | 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 | Sodium; Week 40; n= 61, 66 | 0.2 millimoles per liter (mmol/L) | Standard Deviation 2.42 |
| Placebo | 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 | Sodium; Week 44; n= 61, 66 | 0.1 millimoles per liter (mmol/L) | Standard Deviation 1.77 |
| Placebo | 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 | Sodium; Week 48; n= 61, 64 | 0.1 millimoles per liter (mmol/L) | Standard Deviation 2.03 |
| Placebo | 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 | Sodium; Week 52; n= 60, 65 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 1.79 |
| Placebo | 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 | Sodium; Week 56; n= 61, 63 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.15 |
| Placebo | 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 | Sodium; Week 60; n= 60, 65 | -0.1 millimoles per liter (mmol/L) | Standard Deviation 2.04 |
| Placebo | 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 | Absolute Urea; Baseline; n= 68, 68 | 5.94 millimoles per liter (mmol/L) | Standard Deviation 1.451 |
| Placebo | 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 | Urea; Week 4; n= 68, 68 | -0.08 millimoles per liter (mmol/L) | Standard Deviation 1.412 |
| Placebo | 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 | Urea; Week 8; n= 67, 66 | -0.23 millimoles per liter (mmol/L) | Standard Deviation 1.564 |
| Placebo | 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 | Urea; Week 12; n= 65, 68 | -0.15 millimoles per liter (mmol/L) | Standard Deviation 1.414 |
| Placebo | 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 | Urea; Week 16; n= 65, 68 | -0.07 millimoles per liter (mmol/L) | Standard Deviation 1.569 |
| Placebo | 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 | Urea; Week 20; n= 63, 68 | -0.21 millimoles per liter (mmol/L) | Standard Deviation 1.465 |
| Placebo | 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 | Urea; Week 24; n= 63, 66 | -0.28 millimoles per liter (mmol/L) | Standard Deviation 1.513 |
| Placebo | 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 | Urea; Week 28; n= 62, 66 | -0.21 millimoles per liter (mmol/L) | Standard Deviation 1.525 |
| Placebo | 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 | Urea; Week 32; n= 61, 67 | -0.11 millimoles per liter (mmol/L) | Standard Deviation 1.32 |
| Placebo | 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 | Urea; Week 36; n= 60, 67 | -0.27 millimoles per liter (mmol/L) | Standard Deviation 1.407 |
| Placebo | 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 | Urea; Week 40; n= 61, 66 | -0.44 millimoles per liter (mmol/L) | Standard Deviation 1.377 |
| Placebo | 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 | Urea; Week 44; n= 61, 66 | -0.32 millimoles per liter (mmol/L) | Standard Deviation 1.731 |
| Placebo | 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 | Urea; Week 48; n= 61, 64 | -0.36 millimoles per liter (mmol/L) | Standard Deviation 1.422 |
| Placebo | 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 | Urea; Week 52; n= 60, 65 | -0.19 millimoles per liter (mmol/L) | Standard Deviation 1.737 |
| Placebo | 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 | Urea; Week 56; n= 61, 63 | -0.11 millimoles per liter (mmol/L) | Standard Deviation 1.495 |
| Placebo | 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 | Urea; Week 60; n= 60, 65 | -0.09 millimoles per liter (mmol/L) | Standard Deviation 1.546 |
| Placebo | 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 | Absolute VLDL cholesterol; Baseline; n= 67, 68 | 0.680 millimoles per liter (mmol/L) | Standard Deviation 0.2846 |
| Placebo | 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 | VLDL cholesterol; Week 8; n= 1, 0 | 0.100 millimoles per liter (mmol/L) | — |
| Placebo | 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 | VLDL cholesterol; Week 12; n= 1, 0 | -0.040 millimoles per liter (mmol/L) | — |
| Placebo | 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 | VLDL cholesterol; Week 16; n= 1, 1 | -0.070 millimoles per liter (mmol/L) | — |
| Placebo | 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 | VLDL cholesterol; Week 20; n= 1, 1 | 0.200 millimoles per liter (mmol/L) | — |
| Placebo | 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 | VLDL cholesterol; Week 52; n= 58, 64 | -0.019 millimoles per liter (mmol/L) | Standard Deviation 0.3229 |
| Placebo | 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 | VLDL cholesterol; Week 56; n= 1, 0 | -0.260 millimoles per liter (mmol/L) | — |
| Placebo | 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 | Calcium; Week 4; n= 68, 68 | -0.011 millimoles per liter (mmol/L) | Standard Deviation 0.0836 |
| Placebo | 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 | Calcium; Week 8; n= 67, 66 | -0.013 millimoles per liter (mmol/L) | Standard Deviation 0.0877 |
| Placebo | 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 | Calcium; Week 12; n= 65, 68 | -0.013 millimoles per liter (mmol/L) | Standard Deviation 0.0844 |
| Mepolizumab 300mg | 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 | Absolute Calcium; Baseline; n= 68, 68 | 2.382 millimoles per liter (mmol/L) | Standard Deviation 0.1189 |
| Mepolizumab 300mg | 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 | Sodium; Week 12; n= 65, 68 | -0.1 millimoles per liter (mmol/L) | Standard Deviation 2.28 |
| Mepolizumab 300mg | 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 | Calcium; Week 4; n= 68, 68 | -0.012 millimoles per liter (mmol/L) | Standard Deviation 0.12 |
| Mepolizumab 300mg | 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 | Phosphate; Week 4; n= 68, 68 | 0.014 millimoles per liter (mmol/L) | Standard Deviation 0.1833 |
| Mepolizumab 300mg | 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 | Calcium; Week 8; n= 67, 66 | -0.010 millimoles per liter (mmol/L) | Standard Deviation 0.1003 |
| Mepolizumab 300mg | 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 | Urea; Week 52; n= 60, 65 | -0.18 millimoles per liter (mmol/L) | Standard Deviation 1.128 |
| Mepolizumab 300mg | 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 | Calcium; Week 12; n= 65, 68 | -0.026 millimoles per liter (mmol/L) | Standard Deviation 0.0889 |
| Mepolizumab 300mg | 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 | Phosphate; Week 8; n= 67, 66 | 0.024 millimoles per liter (mmol/L) | Standard Deviation 0.2239 |
| Mepolizumab 300mg | 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 | Calcium; Week 16; n= 65, 68 | -0.029 millimoles per liter (mmol/L) | Standard Deviation 0.1018 |
| Mepolizumab 300mg | 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 | Sodium; Week 16; n= 65, 68 | -0.1 millimoles per liter (mmol/L) | Standard Deviation 1.91 |
| Mepolizumab 300mg | 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 | Calcium; Week 20; n= 63, 68 | -0.016 millimoles per liter (mmol/L) | Standard Deviation 0.1032 |
| Mepolizumab 300mg | 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 | Phosphate; Week 12; n= 65, 68 | 0.019 millimoles per liter (mmol/L) | Standard Deviation 0.2181 |
| Mepolizumab 300mg | 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 | Calcium; Week 24; n= 63, 66 | -0.013 millimoles per liter (mmol/L) | Standard Deviation 0.1111 |
| Mepolizumab 300mg | 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 | Urea; Week 20; n= 63, 68 | -0.23 millimoles per liter (mmol/L) | Standard Deviation 1.286 |
| Mepolizumab 300mg | 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 | Calcium; Week 28; n= 61, 66 | -0.001 millimoles per liter (mmol/L) | Standard Deviation 0.1039 |
| Mepolizumab 300mg | 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 | Phosphate; Week 16; n= 65, 68 | 0.016 millimoles per liter (mmol/L) | Standard Deviation 0.2205 |
| Mepolizumab 300mg | 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 | Calcium; Week 32; n= 61, 67 | -0.006 millimoles per liter (mmol/L) | Standard Deviation 0.0977 |
| Mepolizumab 300mg | 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 | Sodium; Week 20; n= 63, 68 | 0.1 millimoles per liter (mmol/L) | Standard Deviation 2.09 |
| Mepolizumab 300mg | 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 | Calcium; Week 36; n= 60, 67 | -0.006 millimoles per liter (mmol/L) | Standard Deviation 0.1133 |
| Mepolizumab 300mg | 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 | Phosphate; Week 20; n= 63, 68 | 0.019 millimoles per liter (mmol/L) | Standard Deviation 0.2087 |
| Mepolizumab 300mg | 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 | Calcium; Week 40; n= 61, 66 | 0.005 millimoles per liter (mmol/L) | Standard Deviation 0.1115 |
| Mepolizumab 300mg | 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 | VLDL cholesterol; Week 36; n= 0, 1 | -0.230 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | Calcium; Week 44; n= 61, 66 | -0.020 millimoles per liter (mmol/L) | Standard Deviation 0.1115 |
| Mepolizumab 300mg | 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 | Phosphate; Week 24; n= 63, 66 | 0.007 millimoles per liter (mmol/L) | Standard Deviation 0.2142 |
| Mepolizumab 300mg | 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 | Calcium; Week 48; n= 61, 64 | -0.018 millimoles per liter (mmol/L) | Standard Deviation 0.1002 |
| Mepolizumab 300mg | 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 | Sodium; Week 24; n= 63, 66 | 0.0 millimoles per liter (mmol/L) | Standard Deviation 1.95 |
| Mepolizumab 300mg | 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 | Calcium; Week 52; n= 60, 65 | -0.027 millimoles per liter (mmol/L) | Standard Deviation 0.111 |
| Mepolizumab 300mg | 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 | Phosphate; Week 28; n= 62, 66 | 0.003 millimoles per liter (mmol/L) | Standard Deviation 0.2539 |
| Mepolizumab 300mg | 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 | Calcium; Week 56; n= 61, 63 | -0.015 millimoles per liter (mmol/L) | Standard Deviation 0.0994 |
| Mepolizumab 300mg | 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 | Urea; Week 24; n= 63, 66 | -0.12 millimoles per liter (mmol/L) | Standard Deviation 1.172 |
| Mepolizumab 300mg | 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 | Calcium; Week 60; n= 60, 65 | -0.019 millimoles per liter (mmol/L) | Standard Deviation 0.1058 |
| Mepolizumab 300mg | 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 | Phosphate; Week 32; n= 61, 67 | 0.040 millimoles per liter (mmol/L) | Standard Deviation 0.2172 |
| Mepolizumab 300mg | 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 | Absolute Chloride; Baseline; n= 68, 68 | 104.0 millimoles per liter (mmol/L) | Standard Deviation 2.21 |
| Mepolizumab 300mg | 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 | Sodium; Week 28; n= 62, 66 | 0.0 millimoles per liter (mmol/L) | Standard Deviation 2.23 |
| Mepolizumab 300mg | 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 | Chloride; Week 4; n= 68, 68 | 0.2 millimoles per liter (mmol/L) | Standard Deviation 2 |
| Mepolizumab 300mg | 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 | Phosphate; Week 36; n= 60, 67 | 0.023 millimoles per liter (mmol/L) | Standard Deviation 0.226 |
| Mepolizumab 300mg | 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 | Chloride; Week 8; n= 67, 66 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| Mepolizumab 300mg | 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 | Urea; Week 56; n= 61, 63 | -0.13 millimoles per liter (mmol/L) | Standard Deviation 1.539 |
| Mepolizumab 300mg | 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 | Chloride; Week 12; n= 65, 68 | 0.7 millimoles per liter (mmol/L) | Standard Deviation 2.2 |
| Mepolizumab 300mg | 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 | Phosphate; Week 40; n= 61, 66 | 0.026 millimoles per liter (mmol/L) | Standard Deviation 0.2213 |
| Mepolizumab 300mg | 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 | Chloride; Week 16; n= 65, 68 | 0.8 millimoles per liter (mmol/L) | Standard Deviation 1.95 |
| Mepolizumab 300mg | 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 | Sodium; Week 32; n= 61, 67 | 0.1 millimoles per liter (mmol/L) | Standard Deviation 2.13 |
| Mepolizumab 300mg | 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 | Chloride; Week 20; n= 63, 68 | 0.7 millimoles per liter (mmol/L) | Standard Deviation 2.04 |
| Mepolizumab 300mg | 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 | Phosphate; Week 44; n= 61, 66 | 0.041 millimoles per liter (mmol/L) | Standard Deviation 0.224 |
| Mepolizumab 300mg | 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 | Chloride; Week 24; n= 63, 66 | 0.8 millimoles per liter (mmol/L) | Standard Deviation 2.2 |
| Mepolizumab 300mg | 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 | Urea; Week 28; n= 62, 66 | -0.22 millimoles per liter (mmol/L) | Standard Deviation 1.35 |
| Mepolizumab 300mg | 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 | Chloride; Week 28; n= 62, 66 | 0.8 millimoles per liter (mmol/L) | Standard Deviation 2.59 |
| Mepolizumab 300mg | 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 | Phosphate; Week 48; n= 61, 64 | -0.020 millimoles per liter (mmol/L) | Standard Deviation 0.2443 |
| Mepolizumab 300mg | 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 | Chloride; Week 32; n= 61, 67 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 2.32 |
| Mepolizumab 300mg | 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 | Sodium; Week 36; n= 60, 67 | 0.0 millimoles per liter (mmol/L) | Standard Deviation 1.95 |
| Mepolizumab 300mg | 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 | Chloride; Week 36; n= 60, 67 | 0.6 millimoles per liter (mmol/L) | Standard Deviation 2.08 |
| Mepolizumab 300mg | 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 | Phosphate; Week 52; n= 60, 65 | 0.053 millimoles per liter (mmol/L) | Standard Deviation 0.2988 |
| Mepolizumab 300mg | 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 | Chloride; Week 40; n= 61, 66 | 0.7 millimoles per liter (mmol/L) | Standard Deviation 2.13 |
| Mepolizumab 300mg | 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 | VLDL cholesterol; Week 16; n= 1, 1 | 0.640 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | Chloride; Week 44; n= 61, 66 | 0.6 millimoles per liter (mmol/L) | Standard Deviation 2.55 |
| Mepolizumab 300mg | 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 | Phosphate; Week 56; n= 61, 63 | 0.043 millimoles per liter (mmol/L) | Standard Deviation 0.3066 |
| Mepolizumab 300mg | 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 | Chloride; Week 48; n= 61, 64 | 0.5 millimoles per liter (mmol/L) | Standard Deviation 2.34 |
| Mepolizumab 300mg | 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 | Sodium; Week 40; n= 61, 66 | 0.0 millimoles per liter (mmol/L) | Standard Deviation 2.18 |
| Mepolizumab 300mg | 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 | Chloride; Week 52; n= 60, 65 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.24 |
| Mepolizumab 300mg | 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 | Phosphate; Week 60; n= 60, 65 | -0.007 millimoles per liter (mmol/L) | Standard Deviation 0.2322 |
| Mepolizumab 300mg | 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 | Chloride; Week 56; n= 61, 63 | 0.2 millimoles per liter (mmol/L) | Standard Deviation 2.06 |
| Mepolizumab 300mg | 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 | Urea; Week 32; n= 61, 67 | -0.23 millimoles per liter (mmol/L) | Standard Deviation 1.359 |
| Mepolizumab 300mg | 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 | Chloride; Week 60; n= 60, 65 | 0.4 millimoles per liter (mmol/L) | Standard Deviation 2.2 |
| Mepolizumab 300mg | 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 | Absolute Potassium; Baseline; n= 68, 68 | 4.10 millimoles per liter (mmol/L) | Standard Deviation 0.359 |
| Mepolizumab 300mg | 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 | Absolute Cholesterol; Baseline; n= 68, 68 | 5.788 millimoles per liter (mmol/L) | Standard Deviation 1.2386 |
| Mepolizumab 300mg | 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 | Sodium; Week 44; n= 61, 66 | -0.2 millimoles per liter (mmol/L) | Standard Deviation 2.02 |
| Mepolizumab 300mg | 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 | Potassium; Week 4; n= 68, 68 | -0.02 millimoles per liter (mmol/L) | Standard Deviation 0.345 |
| Mepolizumab 300mg | 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 | Urea; Week 60; n= 60, 65 | -0.10 millimoles per liter (mmol/L) | Standard Deviation 1.17 |
| Mepolizumab 300mg | 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 | Cholesterol; Week 16; n= 1, 1 | -0.300 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | Potassium; Week 8; n= 67, 66 | 0.02 millimoles per liter (mmol/L) | Standard Deviation 0.323 |
| Mepolizumab 300mg | 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 | Cholesterol; Week 20; n= 1, 1 | -0.300 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | Cholesterol; Week 24; n= 0, 1 | -0.560 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | Cholesterol; Week 36; n= 0, 1 | 0.420 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | Sodium; Week 48; n= 61, 64 | -0.4 millimoles per liter (mmol/L) | Standard Deviation 1.97 |
| Mepolizumab 300mg | 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 | Cholesterol; Week 52; n= 60, 65 | -0.384 millimoles per liter (mmol/L) | Standard Deviation 0.8798 |
| Mepolizumab 300mg | 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 | Potassium; Week 12; n= 65, 68 | 0.01 millimoles per liter (mmol/L) | Standard Deviation 0.296 |
| Mepolizumab 300mg | 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 | Urea; Week 36; n= 60, 67 | -0.32 millimoles per liter (mmol/L) | Standard Deviation 1.391 |
| Mepolizumab 300mg | 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 | Absolute Glucose; Baseline; n= 68, 68 | 5.35 millimoles per liter (mmol/L) | Standard Deviation 1.195 |
| Mepolizumab 300mg | 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 | Potassium; Week 16; n= 65, 68 | 0.05 millimoles per liter (mmol/L) | Standard Deviation 0.317 |
| Mepolizumab 300mg | 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 | Glucose; Week 4; n= 68, 68 | -0.01 millimoles per liter (mmol/L) | Standard Deviation 1.05 |
| Mepolizumab 300mg | 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 | Sodium; Week 52; n= 60, 65 | -0.2 millimoles per liter (mmol/L) | Standard Deviation 2.17 |
| Mepolizumab 300mg | 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 | Glucose; Week 8; n= 67, 66 | 0.07 millimoles per liter (mmol/L) | Standard Deviation 0.986 |
| Mepolizumab 300mg | 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 | Potassium; Week 20; n= 63, 68 | 0.01 millimoles per liter (mmol/L) | Standard Deviation 0.372 |
| Mepolizumab 300mg | 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 | Glucose; Week 12; n= 65, 68 | 0.26 millimoles per liter (mmol/L) | Standard Deviation 1.079 |
| Mepolizumab 300mg | 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 | VLDL cholesterol; Week 52; n= 58, 64 | -0.051 millimoles per liter (mmol/L) | Standard Deviation 0.1927 |
| Mepolizumab 300mg | 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 | Glucose; Week 16; n= 65, 68 | 0.04 millimoles per liter (mmol/L) | Standard Deviation 1.077 |
| Mepolizumab 300mg | 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 | Potassium; Week 24; n= 63, 66 | 0.04 millimoles per liter (mmol/L) | Standard Deviation 0.35 |
| Mepolizumab 300mg | 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 | Glucose; Week 20; n= 63, 68 | -0.03 millimoles per liter (mmol/L) | Standard Deviation 1.351 |
| Mepolizumab 300mg | 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 | Sodium; Week 56; n= 61, 63 | -0.5 millimoles per liter (mmol/L) | Standard Deviation 2.08 |
| Mepolizumab 300mg | 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 | Glucose; Week 24; n= 63, 66 | 0.16 millimoles per liter (mmol/L) | Standard Deviation 1.211 |
| Mepolizumab 300mg | 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 | Potassium; Week 28; n= 61, 66 | 0.10 millimoles per liter (mmol/L) | Standard Deviation 0.382 |
| Mepolizumab 300mg | 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 | Glucose; Week 28; n= 62, 66 | 0.21 millimoles per liter (mmol/L) | Standard Deviation 1.551 |
| Mepolizumab 300mg | 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 | Urea; Week 40; n= 61, 66 | -0.23 millimoles per liter (mmol/L) | Standard Deviation 1.375 |
| Mepolizumab 300mg | 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 | Glucose; Week 32; n= 61, 67 | -0.14 millimoles per liter (mmol/L) | Standard Deviation 1.162 |
| Mepolizumab 300mg | 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 | Potassium; Week 32; n= 61, 67 | 0.11 millimoles per liter (mmol/L) | Standard Deviation 0.305 |
| Mepolizumab 300mg | 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 | Glucose; Week 36; n= 60, 67 | 0.03 millimoles per liter (mmol/L) | Standard Deviation 1.003 |
| Mepolizumab 300mg | 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 | Sodium; Week 60; n= 60, 65 | -0.3 millimoles per liter (mmol/L) | Standard Deviation 2.36 |
| Mepolizumab 300mg | 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 | Glucose; Week 40; n= 61, 66 | -0.03 millimoles per liter (mmol/L) | Standard Deviation 1.305 |
| Mepolizumab 300mg | 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 | Potassium; Week 36; n= 60, 67 | 0.01 millimoles per liter (mmol/L) | Standard Deviation 0.351 |
| Mepolizumab 300mg | 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 | Glucose; Week 44; n= 61, 66 | -0.05 millimoles per liter (mmol/L) | Standard Deviation 0.891 |
| Mepolizumab 300mg | 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 | Absolute VLDL cholesterol; Baseline; n= 67, 68 | 0.646 millimoles per liter (mmol/L) | Standard Deviation 0.2841 |
| Mepolizumab 300mg | 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 | Glucose; Week 48; n= 61, 64 | 0.21 millimoles per liter (mmol/L) | Standard Deviation 1.74 |
| Mepolizumab 300mg | 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 | Potassium; Week 40; n= 61, 66 | 0.14 millimoles per liter (mmol/L) | Standard Deviation 0.313 |
| Mepolizumab 300mg | 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 | Glucose; Week 52; n= 60, 65 | 0.02 millimoles per liter (mmol/L) | Standard Deviation 1.258 |
| Mepolizumab 300mg | 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 | Absolute Urea; Baseline; n= 68, 68 | 5.79 millimoles per liter (mmol/L) | Standard Deviation 1.629 |
| Mepolizumab 300mg | 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 | Glucose; Week 56; n= 61, 63 | 0.13 millimoles per liter (mmol/L) | Standard Deviation 1.852 |
| Mepolizumab 300mg | 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 | Potassium; Week 44; n= 61, 66 | 0.09 millimoles per liter (mmol/L) | Standard Deviation 0.341 |
| Mepolizumab 300mg | 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 | Glucose; Week 60; n= 60, 65 | 0.11 millimoles per liter (mmol/L) | Standard Deviation 1.483 |
| Mepolizumab 300mg | 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 | Urea; Week 44; n= 61, 66 | -0.19 millimoles per liter (mmol/L) | Standard Deviation 1.698 |
| Mepolizumab 300mg | 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 | Absolute HDL cholesterol; Baseline; n= 68, 68 | 1.937 millimoles per liter (mmol/L) | Standard Deviation 0.5606 |
| Mepolizumab 300mg | 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 | Potassium; Week 48; n= 61, 64 | 0.05 millimoles per liter (mmol/L) | Standard Deviation 0.349 |
| Mepolizumab 300mg | 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 | Urea; Week 4; n= 68, 68 | 0.09 millimoles per liter (mmol/L) | Standard Deviation 1.241 |
| Mepolizumab 300mg | 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 | Potassium; Week 52; n= 60, 65 | 0.01 millimoles per liter (mmol/L) | Standard Deviation 0.329 |
| Mepolizumab 300mg | 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 | HDL cholesterol; Week 16; n= 1, 1 | -0.150 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | VLDL cholesterol; Week 20; n= 1, 1 | 0.490 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | HDL cholesterol; Week 20; n= 1, 1 | -0.250 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | HDL cholesterol; Week 24; n= 0, 1 | -0.390 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | HDL cholesterol; Week 36; n= 0, 1 | 0.400 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | Potassium; Week 56; n= 61, 63 | 0.08 millimoles per liter (mmol/L) | Standard Deviation 0.378 |
| Mepolizumab 300mg | 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 | HDL cholesterol; Week 52; n= 60, 65 | -0.150 millimoles per liter (mmol/L) | Standard Deviation 0.3146 |
| Mepolizumab 300mg | 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 | Urea; Week 8; n= 67, 66 | 0.20 millimoles per liter (mmol/L) | Standard Deviation 1.206 |
| Mepolizumab 300mg | 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 | Potassium; Week 60; n= 60, 65 | 0.10 millimoles per liter (mmol/L) | Standard Deviation 0.39 |
| Mepolizumab 300mg | 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 | Absolute LDL cholesterol; Baseline; n= 67, 68 | 3.205 millimoles per liter (mmol/L) | Standard Deviation 1.0992 |
| Mepolizumab 300mg | 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 | Urea; Week 48; n= 61, 64 | -0.09 millimoles per liter (mmol/L) | Standard Deviation 1.429 |
| Mepolizumab 300mg | 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 | Absolute Sodium; Baseline; n= 68, 68 | 140.3 millimoles per liter (mmol/L) | Standard Deviation 1.83 |
| Mepolizumab 300mg | 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 | Urea; Week 12; n= 65, 68 | -0.10 millimoles per liter (mmol/L) | Standard Deviation 1.217 |
| Mepolizumab 300mg | 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 | LDL cholesterol; Week 16; n= 1, 1 | -0.790 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | Sodium; Week 4; n= 68, 68 | 0.3 millimoles per liter (mmol/L) | Standard Deviation 2.03 |
| Mepolizumab 300mg | 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 | LDL cholesterol; Week 20; n= 1, 1 | -0.540 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | LDL cholesterol; Week 24; n= 0, 1 | 0.040 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | LDL cholesterol; Week 36; n= 0, 1 | 0.250 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | VLDL cholesterol; Week 24; n= 0, 1 | -0.210 millimoles per liter (mmol/L) | — |
| Mepolizumab 300mg | 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 | LDL cholesterol; Week 52; n= 58, 64 | -0.215 millimoles per liter (mmol/L) | Standard Deviation 0.8079 |
| Mepolizumab 300mg | 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 | Sodium; Week 8; n= 67, 66 | 0.2 millimoles per liter (mmol/L) | Standard Deviation 1.89 |
| Mepolizumab 300mg | 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 | Urea; Week 16; n= 65, 68 | 0.00 millimoles per liter (mmol/L) | Standard Deviation 1.317 |
| Mepolizumab 300mg | 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 | Absolute Phosphate; Baseline; n= 68, 68 | 1.066 millimoles per liter (mmol/L) | Standard Deviation 0.1939 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Absolute Troponin; Baseline; n= 68, 68 | 0.013 µg/L | Standard Deviation 0.011 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 4; n= 68, 66 | -0.001 µg/L | Standard Deviation 0.0106 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 8; n= 67, 67 | -0.002 µg/L | Standard Deviation 0.0111 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 12; n= 64, 67 | -0.002 µg/L | Standard Deviation 0.0108 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 16; n= 65, 68 | -0.002 µg/L | Standard Deviation 0.0104 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 20; n= 61, 68 | -0.002 µg/L | Standard Deviation 0.0105 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 24; n= 62, 67 | -0.002 µg/L | Standard Deviation 0.0098 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 28; n= 63, 66 | -0.003 µg/L | Standard Deviation 0.0102 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 32; n= 61, 67 | -0.003 µg/L | Standard Deviation 0.01 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 36; n= 61, 67 | -0.002 µg/L | Standard Deviation 0.0107 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 40; n= 61, 66 | -0.001 µg/L | Standard Deviation 0.0117 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 44; n= 61, 65 | -0.000 µg/L | Standard Deviation 0.0068 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 48; n= 60, 65 | 0.017 µg/L | Standard Deviation 0.1479 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 52; n= 60, 65 | -0.002 µg/L | Standard Deviation 0.0114 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 56; n= 61, 63 | -0.003 µg/L | Standard Deviation 0.0112 |
| Placebo | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 60; n= 59, 65 | -0.003 µg/L | Standard Deviation 0.0109 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 60; n= 59, 65 | -0.001 µg/L | Standard Deviation 0.0093 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Absolute Troponin; Baseline; n= 68, 68 | 0.013 µg/L | Standard Deviation 0.0092 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 32; n= 61, 67 | -0.002 µg/L | Standard Deviation 0.0092 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 4; n= 68, 66 | 0.008 µg/L | Standard Deviation 0.0717 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 48; n= 60, 65 | -0.001 µg/L | Standard Deviation 0.0101 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 8; n= 67, 67 | 0.001 µg/L | Standard Deviation 0.0089 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 36; n= 61, 67 | 0.000 µg/L | Standard Deviation 0.0185 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 12; n= 64, 67 | -0.001 µg/L | Standard Deviation 0.0053 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 56; n= 61, 63 | -0.002 µg/L | Standard Deviation 0.0086 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 16; n= 65, 68 | 0.002 µg/L | Standard Deviation 0.0272 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 40; n= 61, 66 | -0.002 µg/L | Standard Deviation 0.009 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 20; n= 61, 68 | -0.001 µg/L | Standard Deviation 0.0089 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 52; n= 60, 65 | -0.001 µg/L | Standard Deviation 0.0111 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 24; n= 62, 67 | 0.004 µg/L | Standard Deviation 0.0535 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 44; n= 61, 65 | -0.001 µg/L | Standard Deviation 0.0095 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameter of Troponin Levels | Troponin; Week 28; n= 63, 66 | -0.002 µg/L | Standard Deviation 0.009 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | 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 | AST; Week 4; n= 68, 68 | 0.0 International Unit per Liter (IU/L) | Standard Deviation 4.41 |
| Placebo | 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 | AST; Week 28; n= 61, 66 | -0.9 International Unit per Liter (IU/L) | Standard Deviation 5.34 |
| Placebo | 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 | ALT; Week 12; n= 65, 68 | -0.9 International Unit per Liter (IU/L) | Standard Deviation 4.53 |
| Placebo | 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 | AST; Week 32; n= 61, 67 | -0.2 International Unit per Liter (IU/L) | Standard Deviation 4.91 |
| Placebo | 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 | ALT; Week 60; n= 60, 65 | -0.3 International Unit per Liter (IU/L) | Standard Deviation 7.33 |
| Placebo | 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 | AST; Week 40; n= 61, 66 | 0.5 International Unit per Liter (IU/L) | Standard Deviation 5.51 |
| Placebo | 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 | ALT; Week 16; n= 65, 68 | -0.4 International Unit per Liter (IU/L) | Standard Deviation 6.56 |
| Placebo | 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 | AST; Week 36; n= 60, 67 | 0.2 International Unit per Liter (IU/L) | Standard Deviation 4.68 |
| Placebo | 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 | AST; Week 48; n= 61, 64 | 1.1 International Unit per Liter (IU/L) | Standard Deviation 6.86 |
| Placebo | 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 | ALT; Week 20; n= 63, 68 | -0.3 International Unit per Liter (IU/L) | Standard Deviation 6.25 |
| Placebo | 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 | AST; Week 52; n= 60, 65 | 0.9 International Unit per Liter (IU/L) | Standard Deviation 6.84 |
| Placebo | 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 | AST; Week 44; n= 61, 66 | 0.4 International Unit per Liter (IU/L) | Standard Deviation 5.77 |
| Placebo | 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 | ALT; Week 24; n= 63, 66 | -1.3 International Unit per Liter (IU/L) | Standard Deviation 5.38 |
| Placebo | 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 | AST; Week 60; n= 60, 65 | -0.4 International Unit per Liter (IU/L) | Standard Deviation 5.24 |
| Placebo | 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 | AST; Week 56; n= 61, 63 | -0.2 International Unit per Liter (IU/L) | Standard Deviation 4.92 |
| Placebo | 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 | Absolute Creatinine kinase; Baseline; n= 68, 68 | 99.0 International Unit per Liter (IU/L) | Standard Deviation 75.99 |
| Placebo | 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 | ALT; Week 28; n= 62, 66 | -0.9 International Unit per Liter (IU/L) | Standard Deviation 6.73 |
| Placebo | 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 | Creatinine kinase; Week 4; n= 68, 68 | -2.4 International Unit per Liter (IU/L) | Standard Deviation 83.23 |
| Placebo | 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 | ALT; Week 44; n= 61, 66 | 0.9 International Unit per Liter (IU/L) | Standard Deviation 9.68 |
| Placebo | 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 | Creatinine kinase; Week 12; n= 65, 68 | 5.4 International Unit per Liter (IU/L) | Standard Deviation 93.24 |
| Placebo | 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 | ALT; Week 32; n= 61, 67 | -0.7 International Unit per Liter (IU/L) | Standard Deviation 6.79 |
| Placebo | 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 | Creatinine kinase; Week 16; n= 65, 68 | 15.8 International Unit per Liter (IU/L) | Standard Deviation 125.84 |
| Placebo | 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 | Creatinine kinase; Week 8; n= 67, 66 | -5.0 International Unit per Liter (IU/L) | Standard Deviation 62.41 |
| Placebo | 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 | Creatinine kinase; Week 20; n= 63, 68 | 1.3 International Unit per Liter (IU/L) | Standard Deviation 78.35 |
| Placebo | 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 | ALT; Week 36; n= 60, 67 | -0.1 International Unit per Liter (IU/L) | Standard Deviation 6.21 |
| Placebo | 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 | Creatinine kinase; Week 24; n= 63, 66 | -0.6 International Unit per Liter (IU/L) | Standard Deviation 56.55 |
| Placebo | 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 | Alk. phosph.; Week 12; n= 65, 68 | -1.9 International Unit per Liter (IU/L) | Standard Deviation 8.36 |
| Placebo | 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 | Creatinine kinase; Week 28; n= 62, 66 | -15.9 International Unit per Liter (IU/L) | Standard Deviation 59.38 |
| Placebo | 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 | Creatinine kinase; Week 32; n= 61, 67 | -13.1 International Unit per Liter (IU/L) | Standard Deviation 59.29 |
| Placebo | 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 | Alk. phosph.; Week 16; n= 65, 68 | -1.3 International Unit per Liter (IU/L) | Standard Deviation 9.35 |
| Placebo | 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 | Creatinine kinase; Week 36; n= 60, 67 | -12.0 International Unit per Liter (IU/L) | Standard Deviation 65.11 |
| Placebo | 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 | Absolute Alk.phosph.; Baseline; n= 68, 68 | 61.2 International Unit per Liter (IU/L) | Standard Deviation 17.83 |
| Placebo | 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 | Creatinine kinase; Week 40; n= 61, 66 | 2.6 International Unit per Liter (IU/L) | Standard Deviation 91.89 |
| Placebo | 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 | Creatinine kinase; Week 44; n= 61, 66 | 5.8 International Unit per Liter (IU/L) | Standard Deviation 86.76 |
| Placebo | 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 | Alk. phosph.; Week 20; n= 63, 68 | 0.0 International Unit per Liter (IU/L) | Standard Deviation 11.24 |
| Placebo | 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 | Creatinine kinase; Week 48; n= 61, 64 | -8.1 International Unit per Liter (IU/L) | Standard Deviation 70.09 |
| Placebo | 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 | Creatinine kinase; Week 52; n= 60, 65 | 0.9 International Unit per Liter (IU/L) | Standard Deviation 67.51 |
| Placebo | 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 | ALT; Week 52; n= 60, 65 | 1.5 International Unit per Liter (IU/L) | Standard Deviation 10.42 |
| Placebo | 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 | Creatinine kinase; Week 60; n= 60, 65 | -10.3 International Unit per Liter (IU/L) | Standard Deviation 65.83 |
| Placebo | 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 | Alk. phosph.; Week 28; n= 62, 66 | 0.2 International Unit per Liter (IU/L) | Standard Deviation 10.95 |
| Placebo | 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 | Absolute GGT; Baseline; n= 68, 68 | 30.8 International Unit per Liter (IU/L) | Standard Deviation 25.49 |
| Placebo | 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 | Creatinine kinase; Week 56; n= 61, 63 | -8.7 International Unit per Liter (IU/L) | Standard Deviation 60.58 |
| Placebo | 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 | GGT; Week 4; n= 68, 68 | 0.2 International Unit per Liter (IU/L) | Standard Deviation 11.7 |
| Placebo | 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 | Alk. phosph.; Week 32; n= 61, 67 | 0.2 International Unit per Liter (IU/L) | Standard Deviation 11.14 |
| Placebo | 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 | GGT; Week 8; n= 67, 66 | -1.0 International Unit per Liter (IU/L) | Standard Deviation 8.59 |
| Placebo | 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 | Alk.phosph.; Week 4; n= 68, 68 | -0.9 International Unit per Liter (IU/L) | Standard Deviation 6.65 |
| Placebo | 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 | GGT; Week 12; n= 65, 68 | -2.9 International Unit per Liter (IU/L) | Standard Deviation 6.68 |
| Placebo | 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 | Alk. phosph.; Week 36; n= 60, 67 | 0.2 International Unit per Liter (IU/L) | Standard Deviation 10.42 |
| Placebo | 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 | GGT; Week 16; n= 65, 68 | -2.1 International Unit per Liter (IU/L) | Standard Deviation 10.18 |
| Placebo | 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 | Alk. phosph.; Week 40; n= 61, 66 | 1.0 International Unit per Liter (IU/L) | Standard Deviation 10.08 |
| Placebo | 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 | GGT; Week 20; n= 63, 68 | 1.7 International Unit per Liter (IU/L) | Standard Deviation 19.02 |
| Placebo | 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 | GGT; Week 36; n= 60, 67 | -2.1 International Unit per Liter (IU/L) | Standard Deviation 10.64 |
| Placebo | 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 | GGT; Week 24; n= 63, 66 | -1.7 International Unit per Liter (IU/L) | Standard Deviation 11.83 |
| Placebo | 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 | Alk. phosph.; Week 44; n= 61, 66 | 1.1 International Unit per Liter (IU/L) | Standard Deviation 12.55 |
| Placebo | 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 | GGT; Week 28; n= 62, 66 | -1.9 International Unit per Liter (IU/L) | Standard Deviation 11.71 |
| Placebo | 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 | ALT; Week 40; n= 61, 66 | 0.3 International Unit per Liter (IU/L) | Standard Deviation 9.01 |
| Placebo | 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 | GGT; Week 32; n= 61, 67 | -1.5 International Unit per Liter (IU/L) | Standard Deviation 15.77 |
| Placebo | 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 | GGT; Week 40; n= 61, 66 | -0.2 International Unit per Liter (IU/L) | Standard Deviation 16.05 |
| Placebo | 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 | Alk. phosph.; Week 48; n= 61, 64 | 1.2 International Unit per Liter (IU/L) | Standard Deviation 11.66 |
| Placebo | 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 | GGT; Week 44; n= 61, 66 | -2.9 International Unit per Liter (IU/L) | Standard Deviation 8.26 |
| Placebo | 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 | GGT; Week 48; n= 61, 64 | 0.9 International Unit per Liter (IU/L) | Standard Deviation 18.91 |
| Placebo | 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 | Alk. phosph.; Week 52; n= 60, 65 | 0.3 International Unit per Liter (IU/L) | Standard Deviation 12.3 |
| Placebo | 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 | GGT; Week 52; n= 60, 65 | -1.6 International Unit per Liter (IU/L) | Standard Deviation 16.44 |
| Placebo | 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 | GGT; Week 60; n= 60, 65 | -4.8 International Unit per Liter (IU/L) | Standard Deviation 16.45 |
| Placebo | 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 | Alk.phosph.; Week 8; n= 67, 66 | -1.7 International Unit per Liter (IU/L) | Standard Deviation 9.95 |
| Placebo | 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 | Alk. phosph.; Week 56; n= 61, 63 | -0.9 International Unit per Liter (IU/L) | Standard Deviation 12.04 |
| Placebo | 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 | Lactate dehydro; Week 4; n= 68, 68 | -3.6 International Unit per Liter (IU/L) | Standard Deviation 19.73 |
| Placebo | 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 | GGT; Week 56; n= 61, 63 | -5.0 International Unit per Liter (IU/L) | Standard Deviation 16.77 |
| Placebo | 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 | Lactate dehydro; Week 8; n= 67, 66 | -8.2 International Unit per Liter (IU/L) | Standard Deviation 29.91 |
| Placebo | 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 | Alk. phosph.; Week 60; n= 60, 65 | -1.5 International Unit per Liter (IU/L) | Standard Deviation 13.16 |
| Placebo | 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 | Lactate dehydro; Week 12; n= 65, 68 | -2.2 International Unit per Liter (IU/L) | Standard Deviation 27.17 |
| Placebo | 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 | ALT; Week 56; n= 61, 63 | -0.1 International Unit per Liter (IU/L) | Standard Deviation 7.35 |
| Placebo | 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 | Lactate dehydro; Week 16; n= 65, 68 | -2.6 International Unit per Liter (IU/L) | Standard Deviation 32.13 |
| Placebo | 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 | Absolute AST; Baseline; n= 68, 68 | 19.3 International Unit per Liter (IU/L) | Standard Deviation 6.11 |
| Placebo | 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 | Lactate dehydro; Week 20; n= 63, 68 | 2.2 International Unit per Liter (IU/L) | Standard Deviation 26.8 |
| Placebo | 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 | Absolute Lactate dehydro; Baseline; n= 68, 68 | 186.5 International Unit per Liter (IU/L) | Standard Deviation 47.82 |
| Placebo | 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 | Lactate dehydro; Week 24; n= 63, 66 | -4.3 International Unit per Liter (IU/L) | Standard Deviation 26.22 |
| Placebo | 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 | Absolute ALT; Baseline; n= 68, 68 | 19.9 International Unit per Liter (IU/L) | Standard Deviation 8.91 |
| Placebo | 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 | Lactate dehydro; Week 28; n= 61, 66 | -8.5 International Unit per Liter (IU/L) | Standard Deviation 27.77 |
| Placebo | 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 | AST; Week 8; n= 67, 66 | -0.4 International Unit per Liter (IU/L) | Standard Deviation 4.77 |
| Placebo | 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 | Lactate dehydro; Week 32; n= 61, 67 | -8.3 International Unit per Liter (IU/L) | Standard Deviation 25.49 |
| Placebo | 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 | Alk. phosph.; Week 24; n= 63, 66 | -1.1 International Unit per Liter (IU/L) | Standard Deviation 10.65 |
| Placebo | 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 | Lactate dehydro; Week 36; n= 60, 67 | -3.6 International Unit per Liter (IU/L) | Standard Deviation 36.45 |
| Placebo | 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 | AST; Week 12; n= 65, 68 | 0.5 International Unit per Liter (IU/L) | Standard Deviation 4.41 |
| Placebo | 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 | Lactate dehydro; Week 40; n= 61, 66 | -4.5 International Unit per Liter (IU/L) | Standard Deviation 35.81 |
| Placebo | 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 | ALT; Week 4; n= 68, 68 | 0.2 International Unit per Liter (IU/L) | Standard Deviation 6.17 |
| Placebo | 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 | Lactate dehydro; Week 44; n= 61, 66 | -2.7 International Unit per Liter (IU/L) | Standard Deviation 33.4 |
| Placebo | 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 | AST; Week 16; n= 65, 68 | 0.4 International Unit per Liter (IU/L) | Standard Deviation 5.48 |
| Placebo | 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 | Lactate dehydro; Week 48; n= 61, 64 | 0.8 International Unit per Liter (IU/L) | Standard Deviation 43.82 |
| Placebo | 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 | ALT; Week 48; n= 61, 64 | 1.7 International Unit per Liter (IU/L) | Standard Deviation 9.04 |
| Placebo | 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 | Lactate dehydro; Week 52; n= 60, 65 | -0.1 International Unit per Liter (IU/L) | Standard Deviation 34.99 |
| Placebo | 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 | AST; Week 20; n= 63, 68 | 0.8 International Unit per Liter (IU/L) | Standard Deviation 4.66 |
| Placebo | 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 | Lactate dehydro; Week 56; n= 61, 63 | -5.2 International Unit per Liter (IU/L) | Standard Deviation 32.69 |
| Placebo | 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 | ALT; Week 8; n= 67, 66 | -0.9 International Unit per Liter (IU/L) | Standard Deviation 5.66 |
| Placebo | 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 | Lactate dehydro; Week 60; n= 60, 65 | -3.5 International Unit per Liter (IU/L) | Standard Deviation 34.15 |
| Placebo | 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 | AST; Week 24; n= 63, 66 | 0.0 International Unit per Liter (IU/L) | Standard Deviation 4.46 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 60; n= 60, 65 | -12.4 International Unit per Liter (IU/L) | Standard Deviation 33.23 |
| Mepolizumab 300mg | 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 | ALT; Week 40; n= 61, 66 | -2.3 International Unit per Liter (IU/L) | Standard Deviation 11.7 |
| Mepolizumab 300mg | 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 | ALT; Week 44; n= 61, 66 | -2.7 International Unit per Liter (IU/L) | Standard Deviation 9.51 |
| Mepolizumab 300mg | 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 | ALT; Week 48; n= 61, 64 | -1.6 International Unit per Liter (IU/L) | Standard Deviation 15.47 |
| Mepolizumab 300mg | 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 | ALT; Week 52; n= 60, 65 | -2.8 International Unit per Liter (IU/L) | Standard Deviation 12.87 |
| Mepolizumab 300mg | 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 | ALT; Week 56; n= 61, 63 | -3.6 International Unit per Liter (IU/L) | Standard Deviation 12.79 |
| Mepolizumab 300mg | 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 | ALT; Week 60; n= 60, 65 | -4.7 International Unit per Liter (IU/L) | Standard Deviation 14.11 |
| Mepolizumab 300mg | 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 | Absolute Alk.phosph.; Baseline; n= 68, 68 | 60.4 International Unit per Liter (IU/L) | Standard Deviation 20.9 |
| Mepolizumab 300mg | 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 | Alk.phosph.; Week 4; n= 68, 68 | -3.2 International Unit per Liter (IU/L) | Standard Deviation 10.01 |
| Mepolizumab 300mg | 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 | Alk.phosph.; Week 8; n= 67, 66 | -1.7 International Unit per Liter (IU/L) | Standard Deviation 11.56 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 36; n= 60, 67 | 4.8 International Unit per Liter (IU/L) | Standard Deviation 14.71 |
| Mepolizumab 300mg | 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 | AST; Week 32; n= 61, 67 | -1.3 International Unit per Liter (IU/L) | Standard Deviation 10.67 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 4; n= 68, 68 | 2.0 International Unit per Liter (IU/L) | Standard Deviation 60.92 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 40; n= 61, 66 | 2.8 International Unit per Liter (IU/L) | Standard Deviation 62.74 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 52; n= 60, 65 | 0.2 International Unit per Liter (IU/L) | Standard Deviation 53.45 |
| Mepolizumab 300mg | 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 | GGT; Week 32; n= 61, 67 | -3.6 International Unit per Liter (IU/L) | Standard Deviation 17.87 |
| Mepolizumab 300mg | 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 | GGT; Week 36; n= 60, 67 | -4.7 International Unit per Liter (IU/L) | Standard Deviation 14.96 |
| Mepolizumab 300mg | 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 | GGT; Week 52; n= 60, 65 | -4.2 International Unit per Liter (IU/L) | Standard Deviation 13.53 |
| Mepolizumab 300mg | 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 | GGT; Week 56; n= 61, 63 | -3.6 International Unit per Liter (IU/L) | Standard Deviation 17.02 |
| Mepolizumab 300mg | 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 | Absolute ALT; Baseline; n= 68, 68 | 21.3 International Unit per Liter (IU/L) | Standard Deviation 14.22 |
| Mepolizumab 300mg | 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 | ALT; Week 4; n= 68, 68 | -2.2 International Unit per Liter (IU/L) | Standard Deviation 8.59 |
| Mepolizumab 300mg | 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 | ALT; Week 8; n= 67, 66 | -1.7 International Unit per Liter (IU/L) | Standard Deviation 10.14 |
| Mepolizumab 300mg | 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 | ALT; Week 12; n= 65, 68 | -0.7 International Unit per Liter (IU/L) | Standard Deviation 12.65 |
| Mepolizumab 300mg | 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 | ALT; Week 16; n= 65, 68 | -2.2 International Unit per Liter (IU/L) | Standard Deviation 9.73 |
| Mepolizumab 300mg | 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 | ALT; Week 20; n= 63, 68 | -1.2 International Unit per Liter (IU/L) | Standard Deviation 12.3 |
| Mepolizumab 300mg | 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 | ALT; Week 24; n= 63, 66 | -0.2 International Unit per Liter (IU/L) | Standard Deviation 15.77 |
| Mepolizumab 300mg | 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 | ALT; Week 28; n= 62, 66 | -0.4 International Unit per Liter (IU/L) | Standard Deviation 13.62 |
| Mepolizumab 300mg | 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 | ALT; Week 32; n= 61, 67 | -2.4 International Unit per Liter (IU/L) | Standard Deviation 11.3 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 12; n= 65, 68 | -1.1 International Unit per Liter (IU/L) | Standard Deviation 12.99 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 16; n= 65, 68 | -1.1 International Unit per Liter (IU/L) | Standard Deviation 14.61 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 20; n= 63, 68 | 4.4 International Unit per Liter (IU/L) | Standard Deviation 21.9 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 24; n= 63, 66 | 2.8 International Unit per Liter (IU/L) | Standard Deviation 17.64 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 28; n= 62, 66 | 4.9 International Unit per Liter (IU/L) | Standard Deviation 17.17 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 32; n= 61, 67 | 4.4 International Unit per Liter (IU/L) | Standard Deviation 15.83 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 40; n= 61, 66 | 6.2 International Unit per Liter (IU/L) | Standard Deviation 18.43 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 44; n= 61, 66 | 5.1 International Unit per Liter (IU/L) | Standard Deviation 16.53 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 48; n= 61, 64 | 5.1 International Unit per Liter (IU/L) | Standard Deviation 17.56 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 52; n= 60, 65 | 2.3 International Unit per Liter (IU/L) | Standard Deviation 14.47 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 56; n= 61, 63 | 1.7 International Unit per Liter (IU/L) | Standard Deviation 16.42 |
| Mepolizumab 300mg | 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 | Alk. phosph.; Week 60; n= 60, 65 | 1.0 International Unit per Liter (IU/L) | Standard Deviation 15.08 |
| Mepolizumab 300mg | 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 | Absolute AST; Baseline; n= 68, 68 | 21.8 International Unit per Liter (IU/L) | Standard Deviation 10.73 |
| Mepolizumab 300mg | 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 | AST; Week 4; n= 68, 68 | -1.7 International Unit per Liter (IU/L) | Standard Deviation 8.61 |
| Mepolizumab 300mg | 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 | AST; Week 8; n= 67, 66 | -1.0 International Unit per Liter (IU/L) | Standard Deviation 8.21 |
| Mepolizumab 300mg | 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 | AST; Week 12; n= 65, 68 | -0.7 International Unit per Liter (IU/L) | Standard Deviation 9.62 |
| Mepolizumab 300mg | 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 | AST; Week 16; n= 65, 68 | -0.6 International Unit per Liter (IU/L) | Standard Deviation 7.9 |
| Mepolizumab 300mg | 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 | AST; Week 20; n= 63, 68 | -0.6 International Unit per Liter (IU/L) | Standard Deviation 8.49 |
| Mepolizumab 300mg | 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 | AST; Week 24; n= 63, 66 | -0.4 International Unit per Liter (IU/L) | Standard Deviation 10.44 |
| Mepolizumab 300mg | 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 | AST; Week 28; n= 61, 66 | -0.4 International Unit per Liter (IU/L) | Standard Deviation 10.59 |
| Mepolizumab 300mg | 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 | AST; Week 36; n= 60, 67 | -2.2 International Unit per Liter (IU/L) | Standard Deviation 9.61 |
| Mepolizumab 300mg | 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 | AST; Week 40; n= 61, 66 | -1.6 International Unit per Liter (IU/L) | Standard Deviation 8.97 |
| Mepolizumab 300mg | 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 | AST; Week 44; n= 61, 66 | -2.4 International Unit per Liter (IU/L) | Standard Deviation 9.02 |
| Mepolizumab 300mg | 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 | AST; Week 48; n= 61, 64 | -2.3 International Unit per Liter (IU/L) | Standard Deviation 10.14 |
| Mepolizumab 300mg | 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 | AST; Week 52; n= 60, 65 | -3.0 International Unit per Liter (IU/L) | Standard Deviation 10.49 |
| Mepolizumab 300mg | 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 | AST; Week 56; n= 61, 63 | -2.8 International Unit per Liter (IU/L) | Standard Deviation 10.64 |
| Mepolizumab 300mg | 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 | AST; Week 60; n= 60, 65 | -3.7 International Unit per Liter (IU/L) | Standard Deviation 10.92 |
| Mepolizumab 300mg | 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 | Absolute Creatinine kinase; Baseline; n= 68, 68 | 88.8 International Unit per Liter (IU/L) | Standard Deviation 75.18 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 8; n= 67, 66 | 3.5 International Unit per Liter (IU/L) | Standard Deviation 50.48 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 12; n= 65, 68 | 6.1 International Unit per Liter (IU/L) | Standard Deviation 40.86 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 16; n= 65, 68 | 0.5 International Unit per Liter (IU/L) | Standard Deviation 49.65 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 20; n= 63, 68 | 6.5 International Unit per Liter (IU/L) | Standard Deviation 54.83 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 24; n= 63, 66 | 6.0 International Unit per Liter (IU/L) | Standard Deviation 66.69 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 28; n= 62, 66 | 6.3 International Unit per Liter (IU/L) | Standard Deviation 55.84 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 32; n= 61, 67 | 0.2 International Unit per Liter (IU/L) | Standard Deviation 49.68 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 36; n= 60, 67 | 4.9 International Unit per Liter (IU/L) | Standard Deviation 52.71 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 44; n= 61, 66 | -2.4 International Unit per Liter (IU/L) | Standard Deviation 62.13 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 48; n= 61, 64 | -2.6 International Unit per Liter (IU/L) | Standard Deviation 90.09 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 56; n= 61, 63 | -0.2 International Unit per Liter (IU/L) | Standard Deviation 62.08 |
| Mepolizumab 300mg | 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 | Creatinine kinase; Week 60; n= 60, 65 | 0.4 International Unit per Liter (IU/L) | Standard Deviation 61.45 |
| Mepolizumab 300mg | 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 | Absolute GGT; Baseline; n= 68, 68 | 30.1 International Unit per Liter (IU/L) | Standard Deviation 27.24 |
| Mepolizumab 300mg | 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 | GGT; Week 4; n= 68, 68 | -2.0 International Unit per Liter (IU/L) | Standard Deviation 9.68 |
| Mepolizumab 300mg | 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 | GGT; Week 8; n= 67, 66 | -0.6 International Unit per Liter (IU/L) | Standard Deviation 17.99 |
| Mepolizumab 300mg | 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 | GGT; Week 12; n= 65, 68 | -1.9 International Unit per Liter (IU/L) | Standard Deviation 18.7 |
| Mepolizumab 300mg | 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 | GGT; Week 16; n= 65, 68 | -1.5 International Unit per Liter (IU/L) | Standard Deviation 21.36 |
| Mepolizumab 300mg | 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 | GGT; Week 20; n= 63, 68 | -1.1 International Unit per Liter (IU/L) | Standard Deviation 24.5 |
| Mepolizumab 300mg | 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 | GGT; Week 24; n= 63, 66 | -3.3 International Unit per Liter (IU/L) | Standard Deviation 22.52 |
| Mepolizumab 300mg | 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 | GGT; Week 28; n= 62, 66 | -3.1 International Unit per Liter (IU/L) | Standard Deviation 16.86 |
| Mepolizumab 300mg | 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 | GGT; Week 40; n= 61, 66 | -0.3 International Unit per Liter (IU/L) | Standard Deviation 19.75 |
| Mepolizumab 300mg | 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 | GGT; Week 44; n= 61, 66 | -2.7 International Unit per Liter (IU/L) | Standard Deviation 15.25 |
| Mepolizumab 300mg | 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 | GGT; Week 48; n= 61, 64 | -3.0 International Unit per Liter (IU/L) | Standard Deviation 16.51 |
| Mepolizumab 300mg | 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 | GGT; Week 60; n= 60, 65 | -5.6 International Unit per Liter (IU/L) | Standard Deviation 15.37 |
| Mepolizumab 300mg | 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 | Absolute Lactate dehydro; Baseline; n= 68, 68 | 179.6 International Unit per Liter (IU/L) | Standard Deviation 38.88 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 4; n= 68, 68 | -2.3 International Unit per Liter (IU/L) | Standard Deviation 27.8 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 8; n= 67, 66 | -5.3 International Unit per Liter (IU/L) | Standard Deviation 24.46 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 12; n= 65, 68 | -7.7 International Unit per Liter (IU/L) | Standard Deviation 25.56 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 16; n= 65, 68 | -10.6 International Unit per Liter (IU/L) | Standard Deviation 26.12 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 20; n= 63, 68 | -13.7 International Unit per Liter (IU/L) | Standard Deviation 25.79 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 24; n= 63, 66 | -13.5 International Unit per Liter (IU/L) | Standard Deviation 26.99 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 28; n= 61, 66 | -15.9 International Unit per Liter (IU/L) | Standard Deviation 30.44 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 32; n= 61, 67 | -17.1 International Unit per Liter (IU/L) | Standard Deviation 24.88 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 36; n= 60, 67 | -16.2 International Unit per Liter (IU/L) | Standard Deviation 30.54 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 40; n= 61, 66 | -13.5 International Unit per Liter (IU/L) | Standard Deviation 36.31 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 44; n= 61, 66 | -17.0 International Unit per Liter (IU/L) | Standard Deviation 31.37 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 48; n= 61, 64 | -19.0 International Unit per Liter (IU/L) | Standard Deviation 30.66 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 52; n= 60, 65 | -17.8 International Unit per Liter (IU/L) | Standard Deviation 33.45 |
| Mepolizumab 300mg | 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 | Lactate dehydro; Week 56; n= 61, 63 | -16.0 International Unit per Liter (IU/L) | Standard Deviation 30.87 |
| Mepolizumab 300mg | 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 | ALT; Week 36; n= 60, 67 | -3.0 International Unit per Liter (IU/L) | Standard Deviation 11.66 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 48; n= 61, 64 | -0.4 gram per liter (g/L) | Standard Deviation 2.74 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 60; n= 60, 65 | -0.4 gram per liter (g/L) | Standard Deviation 5.88 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 52; n= 60, 65 | -0.5 gram per liter (g/L) | Standard Deviation 2.45 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 16; n= 65, 68 | -0.6 gram per liter (g/L) | Standard Deviation 2.57 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 56; n= 61, 63 | -0.7 gram per liter (g/L) | Standard Deviation 2.84 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 32; n= 61, 67 | -0.4 gram per liter (g/L) | Standard Deviation 2.71 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 60; n= 60, 65 | -0.9 gram per liter (g/L) | Standard Deviation 2.55 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 20; n= 63, 68 | -0.1 gram per liter (g/L) | Standard Deviation 2.35 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Absolute Protein; Baseline; n= 68, 68 | 67.7 gram per liter (g/L) | Standard Deviation 4.26 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Absolute Albumin; Baseline; n= 68, 68 | 43.4 gram per liter (g/L) | Standard Deviation 2.45 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 4; n= 68, 68 | -0.8 gram per liter (g/L) | Standard Deviation 3 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 24; n= 63, 66 | 0.0 gram per liter (g/L) | Standard Deviation 2.8 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 12; n= 65, 68 | -0.6 gram per liter (g/L) | Standard Deviation 3.57 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 8; n= 67, 66 | -1.5 gram per liter (g/L) | Standard Deviation 2.97 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 16; n= 65, 68 | -0.3 gram per liter (g/L) | Standard Deviation 3.56 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 28; n= 62, 66 | -0.2 gram per liter (g/L) | Standard Deviation 2.67 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 24; n= 63, 66 | 0.2 gram per liter (g/L) | Standard Deviation 3.99 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 4; n= 68, 68 | -0.6 gram per liter (g/L) | Standard Deviation 2.25 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 28; n= 62, 66 | -0.2 gram per liter (g/L) | Standard Deviation 4.13 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 20; n= 63, 68 | 0.0 gram per liter (g/L) | Standard Deviation 3.21 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 32; n= 61, 67 | -0.5 gram per liter (g/L) | Standard Deviation 4.09 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 36; n= 60, 67 | -0.1 gram per liter (g/L) | Standard Deviation 2.58 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 36; n= 60, 67 | -0.2 gram per liter (g/L) | Standard Deviation 3.82 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 8; n= 67, 66 | -0.8 gram per liter (g/L) | Standard Deviation 2.16 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 40; n= 61, 66 | -0.4 gram per liter (g/L) | Standard Deviation 3.48 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 40; n= 61, 66 | -0.2 gram per liter (g/L) | Standard Deviation 2.98 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 44; n= 61, 66 | 0.4 gram per liter (g/L) | Standard Deviation 4.43 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; week 56; n= 61, 63 | -0.1 gram per liter (g/L) | Standard Deviation 4.77 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 48; n= 61, 64 | -0.5 gram per liter (g/L) | Standard Deviation 3.94 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 44; n= 61, 66 | 0.3 gram per liter (g/L) | Standard Deviation 2.95 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 52; n= 60, 65 | -0.3 gram per liter (g/L) | Standard Deviation 3.75 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 12; n= 65, 68 | -0.2 gram per liter (g/L) | Standard Deviation 2.47 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 60; n= 60, 65 | -0.7 gram per liter (g/L) | Standard Deviation 4.17 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 8; n= 67, 66 | -0.9 gram per liter (g/L) | Standard Deviation 3.6 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 20; n= 63, 68 | 0.1 gram per liter (g/L) | Standard Deviation 4.28 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 52; n= 60, 65 | -0.4 gram per liter (g/L) | Standard Deviation 4.08 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Absolute Albumin; Baseline; n= 68, 68 | 43.5 gram per liter (g/L) | Standard Deviation 3.01 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 4; n= 68, 68 | -0.1 gram per liter (g/L) | Standard Deviation 2.16 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 8; n= 67, 66 | -0.6 gram per liter (g/L) | Standard Deviation 2.72 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 12; n= 65, 68 | -0.4 gram per liter (g/L) | Standard Deviation 2.64 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 16; n= 65, 68 | -0.6 gram per liter (g/L) | Standard Deviation 2.54 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 20; n= 63, 68 | -0.2 gram per liter (g/L) | Standard Deviation 2.92 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 24; n= 63, 66 | 0.1 gram per liter (g/L) | Standard Deviation 2.72 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 28; n= 62, 66 | 0.1 gram per liter (g/L) | Standard Deviation 2.67 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 32; n= 61, 67 | -0.1 gram per liter (g/L) | Standard Deviation 2.69 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 36; n= 60, 67 | 0.3 gram per liter (g/L) | Standard Deviation 3.01 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 40; n= 61, 66 | 0.2 gram per liter (g/L) | Standard Deviation 2.82 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 44; n= 61, 66 | -0.3 gram per liter (g/L) | Standard Deviation 2.87 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 48; n= 61, 64 | -0.3 gram per liter (g/L) | Standard Deviation 2.77 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 52; n= 60, 65 | -0.3 gram per liter (g/L) | Standard Deviation 3.1 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 56; n= 61, 63 | -0.5 gram per liter (g/L) | Standard Deviation 2.88 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Albumin; Week 60; n= 60, 65 | -0.7 gram per liter (g/L) | Standard Deviation 3.04 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Absolute Protein; Baseline; n= 68, 68 | 67.3 gram per liter (g/L) | Standard Deviation 4.46 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 4; n= 68, 68 | -0.5 gram per liter (g/L) | Standard Deviation 3.19 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 12; n= 65, 68 | -0.6 gram per liter (g/L) | Standard Deviation 3.3 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 16; n= 65, 68 | -0.8 gram per liter (g/L) | Standard Deviation 3.93 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 24; n= 63, 66 | 0.0 gram per liter (g/L) | Standard Deviation 3.96 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 28; n= 62, 66 | -0.1 gram per liter (g/L) | Standard Deviation 3.59 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 32; n= 61, 67 | -0.4 gram per liter (g/L) | Standard Deviation 3.91 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 36; n= 60, 67 | 0.2 gram per liter (g/L) | Standard Deviation 4.45 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 40; n= 61, 66 | 0.1 gram per liter (g/L) | Standard Deviation 3.98 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 44; n= 61, 66 | -0.6 gram per liter (g/L) | Standard Deviation 4.19 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; Week 48; n= 61, 64 | -0.5 gram per liter (g/L) | Standard Deviation 4.29 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Albumin and Protein Levels | Protein; week 56; n= 61, 63 | -0.5 gram per liter (g/L) | Standard Deviation 4.21 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 40; n= 61, 66 | -0.2 micromole per liter (µmol/L) | Standard Deviation 3.22 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 52; n= 60, 65 | -0.2 micromole per liter (µmol/L) | Standard Deviation 2.84 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 48; n= 61, 64 | -0.2 micromole per liter (µmol/L) | Standard Deviation 2.59 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 40; n= 61, 66 | -0.1 micromole per liter (µmol/L) | Standard Deviation 2.56 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 52; n= 60, 65 | -0.1 micromole per liter (µmol/L) | Standard Deviation 3.41 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 24; n= 63, 66 | -0.3 micromole per liter (µmol/L) | Standard Deviation 3.36 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 56; n= 61, 63 | -0.8 micromole per liter (µmol/L) | Standard Deviation 3.17 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 44; n= 61, 66 | -0.1 micromole per liter (µmol/L) | Standard Deviation 2.19 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 4; n= 68, 68 | 0.69 micromole per liter (µmol/L) | Standard Deviation 7.195 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 56; n= 61, 63 | -0.9 micromole per liter (µmol/L) | Standard Deviation 2.72 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 12; n= 65, 68 | 1.50 micromole per liter (µmol/L) | Standard Deviation 9.029 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 56; n= 61, 63 | 0.1 micromole per liter (µmol/L) | Standard Deviation 1.08 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Absolute Creatinine; Baseline; n= 68, 68 | 75.49 micromole per liter (µmol/L) | Standard Deviation 12.878 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 20; n= 63, 68 | 1.73 micromole per liter (µmol/L) | Standard Deviation 6.916 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 60; n= 60, 65 | 0.1 micromole per liter (µmol/L) | Standard Deviation 1.1 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 24; n= 63, 66 | 0.74 micromole per liter (µmol/L) | Standard Deviation 7.775 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 60; n= 60, 65 | -0.6 micromole per liter (µmol/L) | Standard Deviation 2.64 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 28; n= 62, 66 | 0.96 micromole per liter (µmol/L) | Standard Deviation 7.504 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Absolute Indirect bilirubin; Baseline; n= 68, 68 | 7.7 micromole per liter (µmol/L) | Standard Deviation 5.09 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 32; n= 61, 67 | 1.89 micromole per liter (µmol/L) | Standard Deviation 9.809 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 44; n= 61, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 2.5 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 36; n= 60, 67 | 1.42 micromole per liter (µmol/L) | Standard Deviation 6.957 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 4; n= 68, 68 | -0.8 micromole per liter (µmol/L) | Standard Deviation 3.68 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 40; n= 61, 66 | 1.16 micromole per liter (µmol/L) | Standard Deviation 8.253 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 16; n= 65, 68 | -0.9 micromole per liter (µmol/L) | Standard Deviation 3.67 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 44; n= 61, 66 | 2.14 micromole per liter (µmol/L) | Standard Deviation 8.991 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 8; n= 67, 66 | -1.2 micromole per liter (µmol/L) | Standard Deviation 3.86 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 48; n= 61, 64 | 1.53 micromole per liter (µmol/L) | Standard Deviation 7.972 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 28; n= 62, 66 | -0.8 micromole per liter (µmol/L) | Standard Deviation 3.13 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 52; n= 60, 65 | 0.52 micromole per liter (µmol/L) | Standard Deviation 7.719 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 12; n= 65, 68 | -0.3 micromole per liter (µmol/L) | Standard Deviation 2.61 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 56; n= 61, 63 | 1.39 micromole per liter (µmol/L) | Standard Deviation 7.367 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 20; n= 63, 68 | -0.5 micromole per liter (µmol/L) | Standard Deviation 2.37 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 60; n= 60, 65 | 0.34 micromole per liter (µmol/L) | Standard Deviation 7.014 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Absolute Total bilirubin; Baseline; n= 68, 68 | 9.8 micromole per liter (µmol/L) | Standard Deviation 6.14 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Absolute Direct bilirubin; Baseline; n= 68, 68 | 2.1 micromole per liter (µmol/L) | Standard Deviation 1.33 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 8; n= 67, 66 | 1.87 micromole per liter (µmol/L) | Standard Deviation 7.505 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 4; n= 68, 68 | 0.0 micromole per liter (µmol/L) | Standard Deviation 1.06 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; week 4; n= 68, 68 | -0.9 micromole per liter (µmol/L) | Standard Deviation 4.02 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 8; n= 67, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 1.01 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 16; n= 65, 68 | 1.53 micromole per liter (µmol/L) | Standard Deviation 10.012 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 12; n= 65, 68 | 0.0 micromole per liter (µmol/L) | Standard Deviation 0.97 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 8; n= 67, 66 | -1.2 micromole per liter (µmol/L) | Standard Deviation 4.38 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 16; n= 65, 68 | -0.2 micromole per liter (µmol/L) | Standard Deviation 0.96 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 28; n= 62, 66 | -0.7 micromole per liter (µmol/L) | Standard Deviation 2.6 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 20; n= 63, 68 | 0.0 micromole per liter (µmol/L) | Standard Deviation 0.86 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 12; n= 65, 68 | -0.3 micromole per liter (µmol/L) | Standard Deviation 3.01 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 24; n= 63, 66 | 0.1 micromole per liter (µmol/L) | Standard Deviation 0.9 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 24; n= 63, 66 | -0.4 micromole per liter (µmol/L) | Standard Deviation 2.94 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 28; n= 62, 66 | -0.1 micromole per liter (µmol/L) | Standard Deviation 1.2 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 16; n= 65, 68 | -1.1 micromole per liter (µmol/L) | Standard Deviation 4.15 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 32; n= 61, 67 | -0.2 micromole per liter (µmol/L) | Standard Deviation 0.99 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 32; n= 61, 66 | -0.9 micromole per liter (µmol/L) | Standard Deviation 2.48 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 36; n= 60, 67 | -0.1 micromole per liter (µmol/L) | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 20; n= 63, 68 | -0.5 micromole per liter (µmol/L) | Standard Deviation 2.9 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 40; n= 61, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 1.11 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 32; n= 61, 67 | -1.1 micromole per liter (µmol/L) | Standard Deviation 3.07 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 44; n= 61, 66 | 0.1 micromole per liter (µmol/L) | Standard Deviation 0.93 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 60; n= 60, 65 | -0.5 micromole per liter (µmol/L) | Standard Deviation 3.21 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 48; n= 61, 64 | 0.1 micromole per liter (µmol/L) | Standard Deviation 0.99 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 36; n= 60, 67 | -0.7 micromole per liter (µmol/L) | Standard Deviation 3.39 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 52; n= 60, 65 | 0.1 micromole per liter (µmol/L) | Standard Deviation 1.05 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 36; n= 60, 67 | -0.6 micromole per liter (µmol/L) | Standard Deviation 2.77 |
| Placebo | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 48; n= 61, 64 | -0.3 micromole per liter (µmol/L) | Standard Deviation 2.19 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 24; n= 63, 66 | 0.06 micromole per liter (µmol/L) | Standard Deviation 6.538 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 24; n= 63, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 2.71 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 28; n= 62, 66 | 0.3 micromole per liter (µmol/L) | Standard Deviation 4.43 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 44; n= 61, 66 | 0.1 micromole per liter (µmol/L) | Standard Deviation 3.64 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 60; n= 60, 65 | 0.0 micromole per liter (µmol/L) | Standard Deviation 3.42 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Absolute Creatinine; Baseline; n= 68, 68 | 73.00 micromole per liter (µmol/L) | Standard Deviation 12.289 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 4; n= 68, 68 | 2.09 micromole per liter (µmol/L) | Standard Deviation 5.533 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 48; n= 61, 64 | -0.1 micromole per liter (µmol/L) | Standard Deviation 3.13 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 52; n= 60, 65 | 0.5 micromole per liter (µmol/L) | Standard Deviation 3.32 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 56; n= 61, 63 | 0.4 micromole per liter (µmol/L) | Standard Deviation 2.64 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 60; n= 60, 65 | -0.1 micromole per liter (µmol/L) | Standard Deviation 2.81 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 16; n= 65, 68 | 0.1 micromole per liter (µmol/L) | Standard Deviation 3.37 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 20; n= 63, 68 | 0.2 micromole per liter (µmol/L) | Standard Deviation 3 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 24; n= 63, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 2.37 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 28; n= 62, 66 | 0.1 micromole per liter (µmol/L) | Standard Deviation 3.71 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 32; n= 61, 66 | -0.2 micromole per liter (µmol/L) | Standard Deviation 3.02 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 36; n= 60, 67 | 0.0 micromole per liter (µmol/L) | Standard Deviation 3.3 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 40; n= 61, 66 | -0.2 micromole per liter (µmol/L) | Standard Deviation 3.16 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 44; n= 61, 66 | 0.1 micromole per liter (µmol/L) | Standard Deviation 2.99 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 56; n= 61, 63 | 0.1 micromole per liter (µmol/L) | Standard Deviation 1.06 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 60; n= 60, 65 | 0.1 micromole per liter (µmol/L) | Standard Deviation 1.07 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Absolute Indirect bilirubin; Baseline; n= 68, 68 | 6.9 micromole per liter (µmol/L) | Standard Deviation 3.38 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 4; n= 68, 68 | 0.0 micromole per liter (µmol/L) | Standard Deviation 3.06 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 8; n= 67, 66 | -0.1 micromole per liter (µmol/L) | Standard Deviation 2.94 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Indirect bilirubin; Week 12; n= 65, 68 | 0.1 micromole per liter (µmol/L) | Standard Deviation 2.79 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Absolute Total bilirubin; Baseline; n= 68, 68 | 8.8 micromole per liter (µmol/L) | Standard Deviation 4.1 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; week 4; n= 68, 68 | 0.1 micromole per liter (µmol/L) | Standard Deviation 3.48 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 8; n= 67, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 3.5 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 12; n= 65, 68 | 0.1 micromole per liter (µmol/L) | Standard Deviation 3.27 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 16; n= 65, 68 | 0.0 micromole per liter (µmol/L) | Standard Deviation 4.14 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 32; n= 61, 67 | -0.1 micromole per liter (µmol/L) | Standard Deviation 3.63 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 36; n= 60, 67 | 0.1 micromole per liter (µmol/L) | Standard Deviation 4.09 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 40; n= 61, 66 | -0.3 micromole per liter (µmol/L) | Standard Deviation 3.78 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 48; n= 61, 64 | -0.1 micromole per liter (µmol/L) | Standard Deviation 3.77 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 52; n= 60, 65 | 0.7 micromole per liter (µmol/L) | Standard Deviation 3.92 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 56; n= 61, 63 | 0.5 micromole per liter (µmol/L) | Standard Deviation 3.24 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 8; n= 67, 66 | 1.15 micromole per liter (µmol/L) | Standard Deviation 6.737 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 12; n= 65, 68 | 0.34 micromole per liter (µmol/L) | Standard Deviation 7.006 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 16; n= 65, 68 | 2.72 micromole per liter (µmol/L) | Standard Deviation 6.702 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 20; n= 63, 68 | 2.60 micromole per liter (µmol/L) | Standard Deviation 7.739 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Total bilirubin; Week 20; n= 63, 68 | 0.3 micromole per liter (µmol/L) | Standard Deviation 3.57 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 28; n= 62, 66 | 1.02 micromole per liter (µmol/L) | Standard Deviation 7.764 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 32; n= 61, 67 | 1.85 micromole per liter (µmol/L) | Standard Deviation 8.589 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 36; n= 60, 67 | 0.40 micromole per liter (µmol/L) | Standard Deviation 7.839 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 40; n= 61, 66 | 0.34 micromole per liter (µmol/L) | Standard Deviation 8.119 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 44; n= 61, 66 | 0.04 micromole per liter (µmol/L) | Standard Deviation 9.07 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 48; n= 61, 64 | -2.25 micromole per liter (µmol/L) | Standard Deviation 7.398 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 52; n= 60, 65 | -1.35 micromole per liter (µmol/L) | Standard Deviation 7.182 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 56; n= 61, 63 | -0.30 micromole per liter (µmol/L) | Standard Deviation 8.695 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Creatinine; Week 60; n= 60, 65 | -1.22 micromole per liter (µmol/L) | Standard Deviation 10.896 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Absolute Direct bilirubin; Baseline; n= 68, 68 | 1.9 micromole per liter (µmol/L) | Standard Deviation 0.98 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 4; n= 68, 68 | 0.0 micromole per liter (µmol/L) | Standard Deviation 0.84 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 8; n= 67, 66 | 0.1 micromole per liter (µmol/L) | Standard Deviation 0.96 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 12; n= 65, 68 | 0.0 micromole per liter (µmol/L) | Standard Deviation 1.04 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 16; n= 65, 68 | -0.1 micromole per liter (µmol/L) | Standard Deviation 1.2 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 20; n= 63, 68 | 0.1 micromole per liter (µmol/L) | Standard Deviation 1.03 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 24; n= 63, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 0.88 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 28; n= 62, 66 | 0.2 micromole per liter (µmol/L) | Standard Deviation 1.15 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 32; n= 61, 67 | 0.1 micromole per liter (µmol/L) | Standard Deviation 0.99 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 36; n= 60, 67 | 0.1 micromole per liter (µmol/L) | Standard Deviation 1.17 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 40; n= 61, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 0.94 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 44; n= 61, 66 | 0.0 micromole per liter (µmol/L) | Standard Deviation 1.12 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 48; n= 61, 64 | 0.0 micromole per liter (µmol/L) | Standard Deviation 1.17 |
| Mepolizumab 300mg | Change From Baseline in Clinical Chemistry Parameters of Direct, Indirect and Total Bilirubin and Creatinine Levels | Direct bilirubin; Week 52; n= 60, 65 | 0.2 micromole per liter (µmol/L) | Standard Deviation 1.06 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 32; n= 61, 66 | 0.244 10^9 cells/L | Standard Deviation 0.9633 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 20; n= 61, 66 | 0.132 10^9 cells/L | Standard Deviation 0.2684 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 24; n= 61, 66 | 0.061 10^9 cells/L | Standard Deviation 0.229 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 28; n= 62, 65 | 0.107 10^9 cells/L | Standard Deviation 0.2363 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 32; n= 61, 66 | 0.108 10^9 cells/L | Standard Deviation 0.2839 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 36; n= 60, 66 | 0.089 10^9 cells/L | Standard Deviation 0.2992 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 40; n= 61, 65 | 0.084 10^9 cells/L | Standard Deviation 0.2495 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 44; n= 59, 61 | 0.090 10^9 cells/L | Standard Deviation 0.2494 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 48; n= 59, 64 | 0.078 10^9 cells/L | Standard Deviation 0.2261 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 52; n= 60, 64 | 0.075 10^9 cells/L | Standard Deviation 0.2407 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 56; n= 59, 61 | 0.051 10^9 cells/L | Standard Deviation 0.2104 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 60; n= 58, 64 | 0.052 10^9 cells/L | Standard Deviation 0.26 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Neutrophils; Baseline; n= 68, 68 | 7.500 10^9 cells/L | Standard Deviation 2.7424 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 4; n= 66, 66 | -0.124 10^9 cells/L | Standard Deviation 2.617 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 8; n= 65, 66 | -0.572 10^9 cells/L | Standard Deviation 2.6791 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 12; n= 63, 65 | -0.797 10^9 cells/L | Standard Deviation 2.2948 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 16; n= 64, 68 | -0.222 10^9 cells/L | Standard Deviation 2.7666 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 20; n= 61, 66 | -0.560 10^9 cells/L | Standard Deviation 2.3679 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 24; n= 61, 66 | -0.980 10^9 cells/L | Standard Deviation 2.3151 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 28; n= 62, 65 | -0.555 10^9 cells/L | Standard Deviation 2.3719 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 32; n= 61, 66 | -0.762 10^9 cells/L | Standard Deviation 2.4952 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 36; n= 60, 66 | -0.509 10^9 cells/L | Standard Deviation 2.8231 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 40; n= 61, 65 | -0.009 10^9 cells/L | Standard Deviation 3.0467 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Basophils; Baselin; n= 68, 68 | 0.030 10^9 cells/L | Standard Deviation 0.0253 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 4; n= 66, 66 | -0.002 10^9 cells/L | Standard Deviation 0.0302 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 8; n= 65, 66 | 0.005 10^9 cells/L | Standard Deviation 0.0285 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 12; n= 63, 65 | 0.007 10^9 cells/L | Standard Deviation 0.0351 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 16; n= 64, 68 | 0.005 10^9 cells/L | Standard Deviation 0.0333 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 20; n= 61, 66 | 0.005 10^9 cells/L | Standard Deviation 0.0338 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 24; n= 61, 66 | 0.004 10^9 cells/L | Standard Deviation 0.0341 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 28; n= 62, 65 | 0.006 10^9 cells/L | Standard Deviation 0.0411 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 32; n= 61, 66 | 0.010 10^9 cells/L | Standard Deviation 0.0467 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 36; n= 60, 66 | 0.009 10^9 cells/L | Standard Deviation 0.0321 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 40; n= 61, 65 | 0.005 10^9 cells/L | Standard Deviation 0.0357 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 44; n= 59, 61 | 0.008 10^9 cells/L | Standard Deviation 0.0328 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 48; n= 59, 64 | 0.003 10^9 cells/L | Standard Deviation 0.0408 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 52; n= 60, 64 | 0.004 10^9 cells/L | Standard Deviation 0.0289 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 56; n= 59, 61 | 0.009 10^9 cells/L | Standard Deviation 0.0381 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 60; n= 58, 64 | 0.002 10^9 cells/L | Standard Deviation 0.0316 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Eosinophils; Baseline; n= 68, 68 | 0.362 10^9 cells/L | Standard Deviation 0.5835 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 4; n= 66, 66 | -0.054 10^9 cells/L | Standard Deviation 0.3309 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 8; n= 65, 66 | 0.103 10^9 cells/L | Standard Deviation 0.2921 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 12; n= 63, 65 | 0.027 10^9 cells/L | Standard Deviation 0.3515 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 16; n= 64, 68 | 0.058 10^9 cells/L | Standard Deviation 0.4092 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 20; n= 61, 66 | 0.162 10^9 cells/L | Standard Deviation 0.59 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 24; n= 61, 66 | 0.136 10^9 cells/L | Standard Deviation 0.4044 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 44; n= 59, 61 | -0.020 10^9 cells/L | Standard Deviation 3.3497 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 48; n= 59, 64 | -0.403 10^9 cells/L | Standard Deviation 3.2656 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 52; n= 60, 64 | -0.391 10^9 cells/L | Standard Deviation 3.4463 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 56; n= 59, 61 | -0.381 10^9 cells/L | Standard Deviation 3.4297 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 60; n= 58, 64 | -0.048 10^9 cells/L | Standard Deviation 3.5724 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Platelets; Baseline; n= 68, 68 | 259.8 10^9 cells/L | Standard Deviation 61.16 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 4; n= 66, 67 | 4.5 10^9 cells/L | Standard Deviation 38.14 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 8; n= 66, 66 | 5.0 10^9 cells/L | Standard Deviation 43.97 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 12; n= 63, 65 | 3.1 10^9 cells/L | Standard Deviation 50.6 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 16; n= 64, 68 | 15.4 10^9 cells/L | Standard Deviation 71.2 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 20; n= 61, 68 | 12.3 10^9 cells/L | Standard Deviation 49.92 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 24; n= 62, 65 | 10.9 10^9 cells/L | Standard Deviation 50.38 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 28; n= 62, 66 | 13.3 10^9 cells/L | Standard Deviation 55.12 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 32; n= 61, 67 | 12.1 10^9 cells/L | Standard Deviation 45.36 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 36; n= 60, 66 | 9.3 10^9 cells/L | Standard Deviation 42.64 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 28; n= 62, 65 | 0.172 10^9 cells/L | Standard Deviation 0.4365 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 32; n= 61, 66 | 0.079 10^9 cells/L | Standard Deviation 0.3759 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 36; n= 60, 66 | 0.086 10^9 cells/L | Standard Deviation 0.3758 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 40; n= 61, 65 | 0.022 10^9 cells/L | Standard Deviation 0.4448 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 44; n= 59, 61 | 0.051 10^9 cells/L | Standard Deviation 0.4472 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 48; n= 59, 64 | 0.109 10^9 cells/L | Standard Deviation 0.3873 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 52; n= 60, 64 | 0.055 10^9 cells/L | Standard Deviation 0.3764 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 56; n= 59, 61 | 0.071 10^9 cells/L | Standard Deviation 0.4137 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 60; n= 58, 64 | 0.111 10^9 cells/L | Standard Deviation 0.4666 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Leukocytes; Baseline; n= 68, 68 | 9.91 10^9 cells/L | Standard Deviation 2.714 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 4; 66, 66 | -0.11 10^9 cells/L | Standard Deviation 2.109 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 8; n= 65, 66 | -0.18 10^9 cells/L | Standard Deviation 2.562 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 12; n= 63, 65 | -0.53 10^9 cells/L | Standard Deviation 1.765 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 40; n= 61, 65 | 14.7 10^9 cells/L | Standard Deviation 45.63 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 44; n= 60, 63 | 19.3 10^9 cells/L | Standard Deviation 48.88 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 48; n= 59, 64 | 14.2 10^9 cells/L | Standard Deviation 53.93 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 52; n= 60, 64 | 14.7 10^9 cells/L | Standard Deviation 48.19 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 56; n= 59, 61 | 20.3 10^9 cells/L | Standard Deviation 47.35 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 60; n= 59, 64 | 13.0 10^9 cells/L | Standard Deviation 50.07 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; ; Week 16; n= 64, 68 | 0.01 10^9 cells/L | Standard Deviation 2.567 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 20; n= 61, 66 | -0.13 10^9 cells/L | Standard Deviation 2.269 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 24; n= 61, 66 | -0.73 10^9 cells/L | Standard Deviation 2.11 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 28; n= 62, 65 | -0.01 10^9 cells/L | Standard Deviation 2.297 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; week 32; n= 61, 66 | -0.33 10^9 cells/L | Standard Deviation 2.218 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 36; n= 60, 66 | -0.17 10^9 cells/L | Standard Deviation 2.501 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 40; n= 61, 65 | 0.17 10^9 cells/L | Standard Deviation 2.912 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 44; n= 59, 61 | 0.25 10^9 cells/L | Standard Deviation 3.166 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 48; n= 59, 64 | -0.10 10^9 cells/L | Standard Deviation 3.092 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 52; n= 60, 64 | -0.12 10^9 cells/L | Standard Deviation 3.114 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 56; n= 59, 61 | -0.05 10^9 cells/L | Standard Deviation 3.357 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 60; n= 58, 64 | 0.19 10^9 cells/L | Standard Deviation 3.533 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Lymphocytes; Baseline; n= 68, 68 | 1.638 10^9 cells/L | Standard Deviation 0.9375 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 4; n= 66, 66 | 0.031 10^9 cells/L | Standard Deviation 0.899 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 8; n= 65, 66 | 0.245 10^9 cells/L | Standard Deviation 0.8804 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 12; n= 63, 65 | 0.160 10^9 cells/L | Standard Deviation 0.9043 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 16; n= 64, 68 | 0.078 10^9 cells/L | Standard Deviation 1.0337 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 20; n= 61, 66 | 0.137 10^9 cells/L | Standard Deviation 0.7984 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 24; n= 61, 66 | 0.056 10^9 cells/L | Standard Deviation 0.8778 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 28; n= 62, 65 | 0.261 10^9 cells/L | Standard Deviation 1.0966 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 36; n= 60, 66 | 0.156 10^9 cells/L | Standard Deviation 1.0399 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 40; n= 61, 65 | 0.064 10^9 cells/L | Standard Deviation 1.0537 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 44; n= 59, 61 | 0.130 10^9 cells/L | Standard Deviation 0.8773 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 48; n=59, 64 | 0.106 10^9 cells/L | Standard Deviation 0.8396 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 52; n= 60, 64 | 0.144 10^9 cells/L | Standard Deviation 0.9262 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 56; n= 59, 61 | 0.200 10^9 cells/L | Standard Deviation 0.8356 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 60; n= 58, 64 | 0.076 10^9 cells/L | Standard Deviation 0.8821 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Monocytes; Baseline; n= 68, 68 | 0.377 10^9 cells/L | Standard Deviation 0.2126 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; week 4; n= 66, 66 | 0.038 10^9 cells/L | Standard Deviation 0.2444 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 8; n= 65, 66 | 0.052 10^9 cells/L | Standard Deviation 0.2271 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 12; n= 63, 65 | 0.077 10^9 cells/L | Standard Deviation 0.2468 |
| Placebo | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 16; n= 64, 68 | 0.086 10^9 cells/L | Standard Deviation 0.279 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 52; n= 60, 64 | 0.031 10^9 cells/L | Standard Deviation 0.6244 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 32; n= 61, 66 | 0.057 10^9 cells/L | Standard Deviation 0.2069 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 16; n= 64, 68 | 0.031 10^9 cells/L | Standard Deviation 0.2157 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 20; n= 61, 68 | 6.1 10^9 cells/L | Standard Deviation 52.76 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 20; n= 61, 66 | 0.030 10^9 cells/L | Standard Deviation 0.1967 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; week 32; n= 61, 66 | -1.54 10^9 cells/L | Standard Deviation 2.725 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 24; n= 61, 66 | 0.013 10^9 cells/L | Standard Deviation 0.2412 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 24; n= 62, 65 | -4.2 10^9 cells/L | Standard Deviation 40.07 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 28; n= 62, 65 | 0.035 10^9 cells/L | Standard Deviation 0.235 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 24; n= 61, 66 | 0.011 10^9 cells/L | Standard Deviation 0.8077 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 28; n= 62, 66 | 5.4 10^9 cells/L | Standard Deviation 41.57 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 36; n= 60, 66 | 0.072 10^9 cells/L | Standard Deviation 0.2416 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 36; n= 60, 66 | -1.37 10^9 cells/L | Standard Deviation 2.578 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 40; n= 61, 65 | 0.050 10^9 cells/L | Standard Deviation 0.2096 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 32; n= 61, 67 | 0.7 10^9 cells/L | Standard Deviation 43.85 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 44; n= 59, 61 | 0.077 10^9 cells/L | Standard Deviation 0.2176 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 8; n= 65, 66 | 0.039 10^9 cells/L | Standard Deviation 0.1988 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 48; n= 59, 64 | 0.025 10^9 cells/L | Standard Deviation 0.2235 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 36; n= 60, 66 | 0.6 10^9 cells/L | Standard Deviation 37.87 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 52; n= 60, 64 | 0.024 10^9 cells/L | Standard Deviation 0.2098 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 40; n= 61, 65 | -1.28 10^9 cells/L | Standard Deviation 3.284 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 56; n= 59, 61 | 0.037 10^9 cells/L | Standard Deviation 0.2303 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 28; n= 62, 65 | -0.360 10^9 cells/L | Standard Deviation 0.8258 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 60; n= 58, 64 | 0.001 10^9 cells/L | Standard Deviation 0.2165 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 28; n= 62, 65 | 0.004 10^9 cells/L | Standard Deviation 0.7328 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Neutrophils; Baseline; n= 68, 68 | 7.198 10^9 cells/L | Standard Deviation 2.9732 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 32; n= 61, 66 | -0.347 10^9 cells/L | Standard Deviation 0.831 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 4; n= 66, 66 | -0.583 10^9 cells/L | Standard Deviation 2.2703 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 44; n= 59, 61 | -1.57 10^9 cells/L | Standard Deviation 2.198 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 8; n= 65, 66 | -0.443 10^9 cells/L | Standard Deviation 2.56476 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 36; n= 60, 66 | -0.347 10^9 cells/L | Standard Deviation 0.8388 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 12; n= 63, 65 | -0.799 10^9 cells/L | Standard Deviation 2.6278 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 32; n= 61, 66 | 0.031 10^9 cells/L | Standard Deviation 0.7986 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 16; n= 64, 68 | -0.914 10^9 cells/L | Standard Deviation 2.6034 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 40; n= 61, 65 | -0.358 10^9 cells/L | Standard Deviation 0.8396 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 20; n= 61, 66 | -1.243 10^9 cells/L | Standard Deviation 2.6857 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 48; n= 59, 64 | -1.46 10^9 cells/L | Standard Deviation 2.546 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 24; n= 61, 66 | -1.120 10^9 cells/L | Standard Deviation 2.8349 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 44; n= 59, 61 | -0.365 10^9 cells/L | Standard Deviation 0.8604 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 28; n= 62, 65 | -1.335 10^9 cells/L | Standard Deviation 2.9428 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 56; n= 59, 61 | 0.128 10^9 cells/L | Standard Deviation 0.7824 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 32; n= 61, 66 | -1.286 10^9 cells/L | Standard Deviation 2.6995 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 48; n= 59, 64 | -0.364 10^9 cells/L | Standard Deviation 0.854 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 36; n= 60, 66 | -1.131 10^9 cells/L | Standard Deviation 2.4261 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 52; n= 60, 64 | -1.50 10^9 cells/L | Standard Deviation 2.521 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 52; n= 60, 64 | -0.341 10^9 cells/L | Standard Deviation 0.8456 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Basophils; Baselin; n= 68, 68 | 0.028 10^9 cells/L | Standard Deviation 0.0236 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 36; n= 60, 66 | 0.031 10^9 cells/L | Standard Deviation 0.5939 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 4; n= 66, 66 | -0.007 10^9 cells/L | Standard Deviation 0.0282 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 56; n= 59, 61 | -0.351 10^9 cells/L | Standard Deviation 0.8624 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 8; n= 65, 66 | -0.002 10^9 cells/L | Standard Deviation 0.0261 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 56; n= 59, 61 | -1.50 10^9 cells/L | Standard Deviation 2.84 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 12; n= 63, 65 | -0.007 10^9 cells/L | Standard Deviation 0.0222 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 60; n= 58, 64 | -0.302 10^9 cells/L | Standard Deviation 0.8352 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 16; n= 64, 68 | -0.004 10^9 cells/L | Standard Deviation 0.0295 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; week 4; n= 66, 66 | 0.014 10^9 cells/L | Standard Deviation 0.2127 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 20; n= 61, 66 | -0.002 10^9 cells/L | Standard Deviation 0.0287 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Leukocytes; Baseline; n= 68, 68 | 9.54 10^9 cells/L | Standard Deviation 3.13 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 24; n= 61, 66 | -0.002 10^9 cells/L | Standard Deviation 0.0328 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 60; n= 58, 64 | -1.20 10^9 cells/L | Standard Deviation 2.396 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 28; n= 62, 65 | -0.005 10^9 cells/L | Standard Deviation 0.0297 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 4; 66, 66 | -0.77 10^9 cells/L | Standard Deviation 2.356 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 32; n= 61, 66 | 0.002 10^9 cells/L | Standard Deviation 0.0355 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 40; n= 61, 65 | 0.037 10^9 cells/L | Standard Deviation 0.6391 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 36; n= 60, 66 | 0.005 10^9 cells/L | Standard Deviation 0.0424 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 8; n= 65, 66 | -0.83 10^9 cells/L | Standard Deviation 2.511 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 40; n= 61, 65 | -0.002 10^9 cells/L | Standard Deviation 0.0356 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Lymphocytes; Baseline; n= 68, 68 | 1.508 10^9 cells/L | Standard Deviation 0.823 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 44; n= 59, 61 | 0.000 10^9 cells/L | Standard Deviation 0.0296 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 60; n= 58, 64 | -0.101 10^9 cells/L | Standard Deviation 0.6848 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 48; n= 59, 64 | -0.004 10^9 cells/L | Standard Deviation 0.03 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 40; n= 61, 65 | 2.0 10^9 cells/L | Standard Deviation 42.12 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 52; n= 60, 64 | -0.003 10^9 cells/L | Standard Deviation 0.0284 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 4; n= 66, 66 | 0.145 10^9 cells/L | Standard Deviation 0.7485 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 56; n= 59, 61 | -0.003 10^9 cells/L | Standard Deviation 0.0286 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 44; n= 60, 63 | 4.9 10^9 cells/L | Standard Deviation 40.27 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Basophils; Week 60; n= 58, 64 | -0.006 10^9 cells/L | Standard Deviation 0.0248 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 44; n= 59, 61 | 0.059 10^9 cells/L | Standard Deviation 0.6471 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Eosinophils; Baseline; n= 68, 68 | 0.398 10^9 cells/L | Standard Deviation 0.8415 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 48; n= 59, 64 | 5.4 10^9 cells/L | Standard Deviation 44.8 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 4; n= 66, 66 | -0.339 10^9 cells/L | Standard Deviation 0.6794 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 8; n= 65, 66 | -0.048 10^9 cells/L | Standard Deviation 0.6388 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 8; n= 65, 66 | -0.370 10^9 cells/L | Standard Deviation 0.8092 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 52; n= 60, 64 | -3.7 10^9 cells/L | Standard Deviation 46.34 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 12; n= 63, 65 | -0.364 10^9 cells/L | Standard Deviation 0.8407 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Monocytes; Week 12; n= 63, 65 | -0.004 10^9 cells/L | Standard Deviation 0.1985 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 16; n= 64, 68 | -0.355 10^9 cells/L | Standard Deviation 0.828 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 56; n= 59, 61 | -1.0 10^9 cells/L | Standard Deviation 48.51 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 20; n= 61, 66 | -0.347 10^9 cells/L | Standard Deviation 0.8266 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 12; n= 63, 65 | -0.071 10^9 cells/L | Standard Deviation 0.7665 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Eosinophils; Week 24; n= 61, 66 | -0.364 10^9 cells/L | Standard Deviation 0.8211 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 40; n= 61, 65 | -1.010 10^9 cells/L | Standard Deviation 3.3999 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 60; n= 59, 64 | -2.0 10^9 cells/L | Standard Deviation 41.32 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 44; n= 59, 61 | -1.344 10^9 cells/L | Standard Deviation 2.1031 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 12; n= 63, 65 | -1.24 10^9 cells/L | Standard Deviation 2.716 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 48; n= 59, 64 | -1.151 10^9 cells/L | Standard Deviation 2.5806 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 48; n=59, 64 | 0.035 10^9 cells/L | Standard Deviation 0.7368 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 52; n= 60, 64 | -1.211 10^9 cells/L | Standard Deviation 2.2815 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; ; Week 16; n= 64, 68 | -1.16 10^9 cells/L | Standard Deviation 2.827 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 56; n= 59, 61 | -1.311 10^9 cells/L | Standard Deviation 3.0024 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 16; n= 64, 68 | 0.079 10^9 cells/L | Standard Deviation 0.7254 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Neutrophils; Week 60; n= 58, 64 | -0.795 10^9 cells/L | Standard Deviation 2.6501 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 20; n= 61, 66 | -1.43 10^9 cells/L | Standard Deviation 2.649 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Platelets; Baseline; n= 68, 68 | 270.3 10^9 cells/L | Standard Deviation 60.86 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Absolute Monocytes; Baseline; n= 68, 68 | 0.405 10^9 cells/L | Standard Deviation 0.2376 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 4; n= 66, 67 | -1.4 10^9 cells/L | Standard Deviation 33.79 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 24; n= 61, 66 | -1.47 10^9 cells/L | Standard Deviation 2.738 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 8; n= 66, 66 | 4.1 10^9 cells/L | Standard Deviation 26.48 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Lymphocytes; Week 20; n= 61, 66 | 0.127 10^9 cells/L | Standard Deviation 0.7096 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 12; n= 63, 65 | -4.3 10^9 cells/L | Standard Deviation 37.89 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Leukocytes; Week 28; n= 62, 65 | -1.66 10^9 cells/L | Standard Deviation 2.804 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Basophils, Eosinophil, Leukocytes, Lymphocytes, Monocytes, Neutrophils, Platelets Levels | Platelets; Week 16; n= 64, 68 | 1.8 10^9 cells/L | Standard Deviation 40.25 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Absolute, Baseline; n= 68, 68 | 4.64 10^12 cells/L | Standard Deviation 0.511 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 4; n= 66, 67 | -0.07 10^12 cells/L | Standard Deviation 0.228 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 8; n= 66, 66 | -0.07 10^12 cells/L | Standard Deviation 0.278 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 12; n= 63, 65 | -0.04 10^12 cells/L | Standard Deviation 0.273 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 16; n= 64, 68 | -0.02 10^12 cells/L | Standard Deviation 0.266 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 20; n= 61, 68 | 0.03 10^12 cells/L | Standard Deviation 0.243 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 24; n= 62, 66 | 0.02 10^12 cells/L | Standard Deviation 0.252 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 28; n= 62, 66 | 0.03 10^12 cells/L | Standard Deviation 0.286 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 32; n= 61, 67 | 0.06 10^12 cells/L | Standard Deviation 0.3 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 36; n= 60, 66 | 0.08 10^12 cells/L | Standard Deviation 0.314 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 40; n= 61, 65 | 0.09 10^12 cells/L | Standard Deviation 0.274 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 44; n= 60, 64 | 0.13 10^12 cells/L | Standard Deviation 0.332 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 48; n= 59, 64 | 0.14 10^12 cells/L | Standard Deviation 0.293 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 52; n= 60, 64 | 0.10 10^12 cells/L | Standard Deviation 0.309 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 56; n= 59, 61 | 0.06 10^12 cells/L | Standard Deviation 0.365 |
| Placebo | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 60; n= 59, 64 | 0.07 10^12 cells/L | Standard Deviation 0.384 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 60; n= 59, 64 | 0.05 10^12 cells/L | Standard Deviation 0.318 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Absolute, Baseline; n= 68, 68 | 4.58 10^12 cells/L | Standard Deviation 0.456 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 32; n= 61, 67 | 0.09 10^12 cells/L | Standard Deviation 0.273 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 4; n= 66, 67 | -0.03 10^12 cells/L | Standard Deviation 0.226 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 48; n= 59, 64 | 0.10 10^12 cells/L | Standard Deviation 0.271 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 8; n= 66, 66 | -0.01 10^12 cells/L | Standard Deviation 0.211 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 36; n= 60, 66 | 0.14 10^12 cells/L | Standard Deviation 0.299 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 12; n= 63, 65 | -0.04 10^12 cells/L | Standard Deviation 0.252 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 56; n= 59, 61 | 0.07 10^12 cells/L | Standard Deviation 0.284 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 16; n= 64, 68 | -0.01 10^12 cells/L | Standard Deviation 0.243 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 40; n= 61, 65 | 0.09 10^12 cells/L | Standard Deviation 0.27 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 20; n= 61, 68 | 0.03 10^12 cells/L | Standard Deviation 0.252 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 52; n= 60, 64 | 0.09 10^12 cells/L | Standard Deviation 0.251 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 24; n= 62, 66 | 0.05 10^12 cells/L | Standard Deviation 0.265 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 44; n= 60, 64 | 0.08 10^12 cells/L | Standard Deviation 0.26 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Erythrocytes Levels | Week 28; n= 62, 66 | 0.08 10^12 cells/L | Standard Deviation 0.264 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 32; n= 61, 67 | -6.6 g/L | Standard Deviation 8.19 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 4; n= 66, 67 | -1.2 g/L | Standard Deviation 6.02 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 8; n= 66, 66 | -1.5 g/L | Standard Deviation 6.69 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 12; n= 63, 65 | -1.3 g/L | Standard Deviation 7.73 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 16; n= 64, 68 | -2.3 g/L | Standard Deviation 7.11 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 20; n= 61, 68 | -2.2 g/L | Standard Deviation 6.65 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 24; n= 62, 66 | -3.2 g/L | Standard Deviation 10.19 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 28; n= 62, 66 | -4.3 g/L | Standard Deviation 7.07 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Absolute MCHC; Baseline; n= 68, 68 | 324.9 g/L | Standard Deviation 7.53 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 36; n= 60, 66 | -4.7 g/L | Standard Deviation 8.05 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 40; n= 61, 65 | -4.5 g/L | Standard Deviation 8.04 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 44; n= 60, 64 | -4.7 g/L | Standard Deviation 8.51 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 48; n= 59, 64 | -6.0 g/L | Standard Deviation 8.03 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 52; n= 60, 64 | -5.2 g/L | Standard Deviation 7.79 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 60; n= 59, 64 | -1.8 g/L | Standard Deviation 9.86 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 56; n= 59, 61 | -6.9 g/L | Standard Deviation 7.74 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 60; n= 59, 64 | -7.5 g/L | Standard Deviation 7.41 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Absolute Hemoglobin; Baseline; n= 68, 68 | 141.6 g/L | Standard Deviation 12.67 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 4; n= 66, 67 | -2.3 g/L | Standard Deviation 6.86 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 28; n= 62, 66 | -1.3 g/L | Standard Deviation 7.48 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 32; n= 61, 67 | -1.3 g/L | Standard Deviation 8.03 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 36; n= 60, 66 | -0.2 g/L | Standard Deviation 8.5 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 40; n= 61, 65 | 0.1 g/L | Standard Deviation 8.35 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 44; n= 60, 64 | 0.7 g/L | Standard Deviation 9.59 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 48; n= 59, 64 | 0.5 g/L | Standard Deviation 8.2 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 52; n= 60, 64 | 0.1 g/L | Standard Deviation 8.57 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 8; n= 66, 66 | -2.5 g/L | Standard Deviation 7.56 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 12; n= 63, 65 | -1.6 g/L | Standard Deviation 8.28 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 16; n= 64, 68 | -1.6 g/L | Standard Deviation 8.24 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 20; n= 61, 68 | -0.3 g/L | Standard Deviation 6.85 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 24; n= 62, 66 | -1.1 g/L | Standard Deviation 8.06 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 56; n= 59, 61 | -1.5 g/L | Standard Deviation 9.92 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 60; n= 59, 64 | -4.7 g/L | Standard Deviation 9.9 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Absolute MCHC; Baseline; n= 68, 68 | 324.4 g/L | Standard Deviation 7.37 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 48; n= 59, 64 | -1.9 g/L | Standard Deviation 11.07 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 4; n= 66, 67 | -1.1 g/L | Standard Deviation 5.92 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Absolute Hemoglobin; Baseline; n= 68, 68 | 140.6 g/L | Standard Deviation 12.99 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 8; n= 66, 66 | -1.5 g/L | Standard Deviation 6.86 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 20; n= 61, 68 | -1.4 g/L | Standard Deviation 7.64 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 12; n= 63, 65 | 0.3 g/L | Standard Deviation 6.6 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 60; n= 59, 64 | -2.4 g/L | Standard Deviation 11.36 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 16; n= 64, 68 | -2.1 g/L | Standard Deviation 7.88 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 24; n= 62, 66 | -1.6 g/L | Standard Deviation 8.51 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 20; n= 61, 68 | -1.2 g/L | Standard Deviation 7.88 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 52; n= 60, 64 | -1.9 g/L | Standard Deviation 10.36 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 24; n= 62, 66 | -2.6 g/L | Standard Deviation 7.39 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 28; n= 62, 66 | -1.3 g/L | Standard Deviation 8.94 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 28; n= 62, 66 | -2.6 g/L | Standard Deviation 7.33 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 4; n= 66, 67 | -1.8 g/L | Standard Deviation 6.43 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 32; n= 61, 67 | -3.6 g/L | Standard Deviation 7.56 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 32; n= 61, 67 | -1.6 g/L | Standard Deviation 9.22 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 36; n= 60, 66 | -3.3 g/L | Standard Deviation 8.37 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 16; n= 64, 68 | -1.9 g/L | Standard Deviation 7.64 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 40; n= 61, 65 | -3.2 g/L | Standard Deviation 8.96 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 36; n= 60, 66 | -0.4 g/L | Standard Deviation 10.23 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 44; n= 60, 64 | -4.5 g/L | Standard Deviation 9.4 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 8; n= 66, 66 | -1.1 g/L | Standard Deviation 6.28 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 48; n= 59, 64 | -4.8 g/L | Standard Deviation 10.56 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 40; n= 61, 65 | -0.9 g/L | Standard Deviation 9.74 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 56; n= 59, 61 | -1.9 g/L | Standard Deviation 11.48 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 52; n= 60, 64 | -5.3 g/L | Standard Deviation 7.72 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 44; n= 60, 64 | -1.9 g/L | Standard Deviation 10.47 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | MCHC; Week 56; n= 59, 61 | -5.3 g/L | Standard Deviation 7.47 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin Concentration (MCHC) and Hemoglobin Levels | Hemoglobin; Week 12; n= 63, 65 | -2.2 g/L | Standard Deviation 7.17 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Absolute, Baseline; n= 68, 68 | 30.77 Picogram (pg) | Standard Deviation 2.902 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 4; n= 66, 67 | 0.04 Picogram (pg) | Standard Deviation 0.331 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 8; n= 66, 66 | -0.02 Picogram (pg) | Standard Deviation 0.95 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 12; n= 63, 65 | -0.04 Picogram (pg) | Standard Deviation 0.55 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 16; n= 64, 68 | -0.21 Picogram (pg) | Standard Deviation 0.845 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 20; n= 61, 68 | -0.28 Picogram (pg) | Standard Deviation 0.665 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 24; n= 62, 66 | -0.45 Picogram (pg) | Standard Deviation 1.27 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 28; n= 62, 66 | -0.51 Picogram (pg) | Standard Deviation 0.618 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 32; n= 61, 67 | -0.66 Picogram (pg) | Standard Deviation 0.764 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 36; n= 60, 66 | -0.60 Picogram (pg) | Standard Deviation 0.91 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 40; n= 61, 65 | -0.67 Picogram (pg) | Standard Deviation 1.171 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 44; n= 60, 64 | -0.78 Picogram (pg) | Standard Deviation 1.566 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 48; n= 59, 64 | -0.87 Picogram (pg) | Standard Deviation 1.745 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 52; n= 60, 64 | -0.69 Picogram (pg) | Standard Deviation 1.908 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 56; n= 59, 61 | -0.79 Picogram (pg) | Standard Deviation 2.056 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 60; n= 59, 64 | -0.86 Picogram (pg) | Standard Deviation 2.094 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 60; n= 59, 64 | -0.80 Picogram (pg) | Standard Deviation 1.818 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Absolute, Baseline; n= 68, 68 | 30.77 Picogram (pg) | Standard Deviation 2.255 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 32; n= 61, 67 | -0.88 Picogram (pg) | Standard Deviation 1.368 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 4; n= 66, 67 | -0.12 Picogram (pg) | Standard Deviation 0.785 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 48; n= 59, 64 | -0.96 Picogram (pg) | Standard Deviation 1.654 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 8; n= 66, 66 | -0.16 Picogram (pg) | Standard Deviation 0.653 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 36; n= 60, 66 | -0.90 Picogram (pg) | Standard Deviation 1.395 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 12; n= 63, 65 | -0.17 Picogram (pg) | Standard Deviation 0.769 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 56; n= 59, 61 | -0.83 Picogram (pg) | Standard Deviation 1.713 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 16; n= 64, 68 | -0.34 Picogram (pg) | Standard Deviation 0.769 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 40; n= 61, 65 | -0.79 Picogram (pg) | Standard Deviation 1.39 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 20; n= 61, 68 | -0.41 Picogram (pg) | Standard Deviation 0.851 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 52; n= 60, 64 | -0.95 Picogram (pg) | Standard Deviation 1.585 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 24; n= 62, 66 | -0.59 Picogram (pg) | Standard Deviation 0.959 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 44; n= 60, 64 | -0.95 Picogram (pg) | Standard Deviation 1.484 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels | Week 28; n= 62, 66 | -0.70 Picogram (pg) | Standard Deviation 1.184 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Absolute, Baseline; n= 68, 68 | 94.8 femtoliter (fL) | Standard Deviation 9.02 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 4; n= 66, 67 | 0.4 femtoliter (fL) | Standard Deviation 1.67 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 8; n= 66, 66 | 0.3 femtoliter (fL) | Standard Deviation 2.5 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 12; n= 63, 65 | 0.2 femtoliter (fL) | Standard Deviation 2 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 16; n= 64, 68 | 0.0 femtoliter (fL) | Standard Deviation 2.22 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 20; n= 61, 68 | -0.3 femtoliter (fL) | Standard Deviation 1.87 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 24; n= 62, 66 | -0.5 femtoliter (fL) | Standard Deviation 2.21 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 28; n= 62, 66 | -0.4 femtoliter (fL) | Standard Deviation 2.86 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 32; n= 61, 67 | -0.2 femtoliter (fL) | Standard Deviation 3.01 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 36; n= 60, 66 | -0.5 femtoliter (fL) | Standard Deviation 3.55 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 40; n= 61, 65 | -0.9 femtoliter (fL) | Standard Deviation 4.09 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 44; n= 60, 64 | -1.2 femtoliter (fL) | Standard Deviation 5.06 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 48; n= 59, 64 | -1.1 femtoliter (fL) | Standard Deviation 5.96 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 52; n= 60, 64 | -0.8 femtoliter (fL) | Standard Deviation 6.52 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 56; n= 59, 61 | -0.5 femtoliter (fL) | Standard Deviation 6.47 |
| Placebo | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 60; n= 59, 64 | -0.6 femtoliter (fL) | Standard Deviation 6.57 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 60; n= 59, 64 | -1.0 femtoliter (fL) | Standard Deviation 4.49 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Absolute, Baseline; n= 68, 68 | 94.8 femtoliter (fL) | Standard Deviation 6.14 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 32; n= 61, 67 | -1.7 femtoliter (fL) | Standard Deviation 3.56 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 4; n= 66, 67 | 0.0 femtoliter (fL) | Standard Deviation 2.33 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 48; n= 59, 64 | -1.5 femtoliter (fL) | Standard Deviation 4.04 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 8; n= 66, 66 | 0.0 femtoliter (fL) | Standard Deviation 2.58 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 36; n= 60, 66 | -1.9 femtoliter (fL) | Standard Deviation 3.74 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 12; n= 63, 65 | -0.7 femtoliter (fL) | Standard Deviation 2.3 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 56; n= 59, 61 | -1.0 femtoliter (fL) | Standard Deviation 4.15 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 16; n= 64, 68 | -0.4 femtoliter (fL) | Standard Deviation 2.94 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 40; n= 61, 65 | -1.4 femtoliter (fL) | Standard Deviation 3.73 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 20; n= 61, 68 | -0.9 femtoliter (fL) | Standard Deviation 2.66 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 52; n= 60, 64 | -1.3 femtoliter (fL) | Standard Deviation 4.29 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 24; n= 62, 66 | -1.0 femtoliter (fL) | Standard Deviation 2.92 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 44; n= 60, 64 | -1.5 femtoliter (fL) | Standard Deviation 3.91 |
| Mepolizumab 300mg | Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels | Week 28; n= 62, 66 | -1.4 femtoliter (fL) | Standard Deviation 3.48 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Pulse Rate | Week 8; n= 67, 68 | 0.97 beats per minute (bpm) | Standard Deviation 10.718 |
| Placebo | Change From Baseline in Pulse Rate | Absolute Baseline; n= 68, 68 | 77.38 beats per minute (bpm) | Standard Deviation 13.763 |
| Placebo | Change From Baseline in Pulse Rate | Week 4; n= 68, 68 | 2.01 beats per minute (bpm) | Standard Deviation 12.294 |
| Placebo | Change From Baseline in Pulse Rate | Week 12; n= 66, 68 | 1.52 beats per minute (bpm) | Standard Deviation 12.393 |
| Placebo | Change From Baseline in Pulse Rate | Week 16; n= 64, 68 | 0.59 beats per minute (bpm) | Standard Deviation 11.287 |
| Placebo | Change From Baseline in Pulse Rate | Week 20; n= 63, 68 | 1.03 beats per minute (bpm) | Standard Deviation 11.521 |
| Placebo | Change From Baseline in Pulse Rate | Week 24; n= 63, 67 | 0.79 beats per minute (bpm) | Standard Deviation 12.134 |
| Placebo | Change From Baseline in Pulse Rate | Week 28; n= 62, 67 | 1.29 beats per minute (bpm) | Standard Deviation 10.439 |
| Placebo | Change From Baseline in Pulse Rate | Week 32; n= 62, 67 | 1.60 beats per minute (bpm) | Standard Deviation 11.703 |
| Placebo | Change From Baseline in Pulse Rate | Week 36; n= 62, 67 | 3.47 beats per minute (bpm) | Standard Deviation 12.538 |
| Placebo | Change From Baseline in Pulse Rate | Week 40; n= 62, 66 | 2.65 beats per minute (bpm) | Standard Deviation 12.297 |
| Placebo | Change From Baseline in Pulse Rate | Week 44; n= 61, 66 | 3.10 beats per minute (bpm) | Standard Deviation 12.195 |
| Placebo | Change From Baseline in Pulse Rate | Week 48; n= 61, 65 | 3.85 beats per minute (bpm) | Standard Deviation 12.383 |
| Placebo | Change From Baseline in Pulse Rate | Week 52; n= 61, 65 | 1.85 beats per minute (bpm) | Standard Deviation 11.987 |
| Placebo | Change From Baseline in Pulse Rate | Week 56; n= 62, 63 | 2.60 beats per minute (bpm) | Standard Deviation 14.041 |
| Placebo | Change From Baseline in Pulse Rate | Week 60; n= 61, 65 | 1.51 beats per minute (bpm) | Standard Deviation 12.793 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 60; n= 61, 65 | 0.09 beats per minute (bpm) | Standard Deviation 10.28 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 32; n= 62, 67 | -0.31 beats per minute (bpm) | Standard Deviation 10.53 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Absolute Baseline; n= 68, 68 | 75.75 beats per minute (bpm) | Standard Deviation 10.404 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 48; n= 61, 65 | -1.12 beats per minute (bpm) | Standard Deviation 10.315 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 4; n= 68, 68 | 1.87 beats per minute (bpm) | Standard Deviation 10.543 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 8; n= 67, 68 | -1.01 beats per minute (bpm) | Standard Deviation 10.304 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 36; n= 62, 67 | -0.57 beats per minute (bpm) | Standard Deviation 11.422 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 12; n= 66, 68 | -0.12 beats per minute (bpm) | Standard Deviation 10.855 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 56; n= 62, 63 | -0.35 beats per minute (bpm) | Standard Deviation 9.986 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 16; n= 64, 68 | 0.44 beats per minute (bpm) | Standard Deviation 11.411 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 40; n= 62, 66 | 0.74 beats per minute (bpm) | Standard Deviation 11.669 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 20; n= 63, 68 | -0.56 beats per minute (bpm) | Standard Deviation 9.687 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 52; n= 61, 65 | -2.17 beats per minute (bpm) | Standard Deviation 9.596 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 24; n= 63, 67 | 0.37 beats per minute (bpm) | Standard Deviation 10.057 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 44; n= 61, 66 | 0.15 beats per minute (bpm) | Standard Deviation 12.763 |
| Mepolizumab 300mg | Change From Baseline in Pulse Rate | Week 28; n= 62, 67 | 0.16 beats per minute (bpm) | Standard Deviation 10.093 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 32; n= 62, 67 | -2.35 millimeter of mercury (mm of Hg) | Standard Deviation 14.027 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 4; n= 68, 68 | 0.47 millimeter of mercury (mm of Hg) | Standard Deviation 15.865 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 8; n= 67, 68 | 0.07 millimeter of mercury (mm of Hg) | Standard Deviation 14.192 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 12; n= 66, 68 | -1.12 millimeter of mercury (mm of Hg) | Standard Deviation 14.38 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 16; n= 64, 68 | -0.97 millimeter of mercury (mm of Hg) | Standard Deviation 16.63 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 20; n= 63, 68 | -0.97 millimeter of mercury (mm of Hg) | Standard Deviation 15.028 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 24; n= 63, 67 | -1.54 millimeter of mercury (mm of Hg) | Standard Deviation 15.449 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 28; n= 63, 67 | -0.06 millimeter of mercury (mm of Hg) | Standard Deviation 14.337 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | Absolute SBP; Baseline; n= 68, 68 | 127.46 millimeter of mercury (mm of Hg) | Standard Deviation 17.794 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 36; n= 62, 67 | 1.02 millimeter of mercury (mm of Hg) | Standard Deviation 14.663 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 40; n= 62, 66 | 0.90 millimeter of mercury (mm of Hg) | Standard Deviation 14.202 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 44; n= 61, 66 | 1.41 millimeter of mercury (mm of Hg) | Standard Deviation 16.143 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 48; n= 61, 65 | -0.41 millimeter of mercury (mm of Hg) | Standard Deviation 17.14 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP: Week 52; n= 61, 65 | -1.03 millimeter of mercury (mm of Hg) | Standard Deviation 13.2 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 56; n= 62, 63 | 0.06 millimeter of mercury (mm of Hg) | Standard Deviation 15.216 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 60; n= 61, 65 | 0.61 millimeter of mercury (mm of Hg) | Standard Deviation 15.627 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | Absolute DBP; Baseline; n= 68, 68 | 80.21 millimeter of mercury (mm of Hg) | Standard Deviation 10.127 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 4; n= 68, 68 | -2.26 millimeter of mercury (mm of Hg) | Standard Deviation 10.046 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 8; n= 67, 68 | -2.04 millimeter of mercury (mm of Hg) | Standard Deviation 8.461 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 12; n= 66, 68 | -1.92 millimeter of mercury (mm of Hg) | Standard Deviation 10.115 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 16; n= 64, 68 | -1.36 millimeter of mercury (mm of Hg) | Standard Deviation 10.237 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 20; n= 63, 68 | -1.25 millimeter of mercury (mm of Hg) | Standard Deviation 8.092 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 24; n= 63, 67 | -2.24 millimeter of mercury (mm of Hg) | Standard Deviation 8.751 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 28; n= 63, 67 | -2.02 millimeter of mercury (mm of Hg) | Standard Deviation 9.939 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 32; n= 62, 67 | -4.27 millimeter of mercury (mm of Hg) | Standard Deviation 9.313 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 36; n= 62, 67 | -1.97 millimeter of mercury (mm of Hg) | Standard Deviation 10.995 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 40; n= 62, 66 | -0.48 millimeter of mercury (mm of Hg) | Standard Deviation 9.625 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 44; n= 61, 66 | -0.79 millimeter of mercury (mm of Hg) | Standard Deviation 9.93 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 48; n= 61, 65 | -3.26 millimeter of mercury (mm of Hg) | Standard Deviation 10.466 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 52; n= 61, 65 | -3.66 millimeter of mercury (mm of Hg) | Standard Deviation 10.628 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 56; n= 62, 63 | -3.48 millimeter of mercury (mm of Hg) | Standard Deviation 10.57 |
| Placebo | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 60; n= 61, 65 | -2.54 millimeter of mercury (mm of Hg) | Standard Deviation 11.278 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 60; n= 61, 65 | -0.45 millimeter of mercury (mm of Hg) | Standard Deviation 9.836 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | Absolute SBP; Baseline; n= 68, 68 | 122.46 millimeter of mercury (mm of Hg) | Standard Deviation 14.134 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | Absolute DBP; Baseline; n= 68, 68 | 76.22 millimeter of mercury (mm of Hg) | Standard Deviation 9.646 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 4; n= 68, 68 | 0.93 millimeter of mercury (mm of Hg) | Standard Deviation 12.37 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 32; n= 62, 67 | -0.49 millimeter of mercury (mm of Hg) | Standard Deviation 10.652 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 8; n= 67, 68 | 1.29 millimeter of mercury (mm of Hg) | Standard Deviation 11.066 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 4; n= 68, 68 | 1.01 millimeter of mercury (mm of Hg) | Standard Deviation 10.13 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 12; n= 66, 68 | -1.41 millimeter of mercury (mm of Hg) | Standard Deviation 12.071 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 48; n= 61, 65 | -1.71 millimeter of mercury (mm of Hg) | Standard Deviation 9.239 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 16; n= 64, 68 | -0.41 millimeter of mercury (mm of Hg) | Standard Deviation 11.579 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 8; n= 67, 68 | -0.34 millimeter of mercury (mm of Hg) | Standard Deviation 10.078 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 20; n= 63, 68 | -0.85 millimeter of mercury (mm of Hg) | Standard Deviation 12.019 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 36; n= 62, 67 | 0.16 millimeter of mercury (mm of Hg) | Standard Deviation 10.988 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 24; n= 63, 67 | -1.57 millimeter of mercury (mm of Hg) | Standard Deviation 12.824 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 12; n= 66, 68 | -0.37 millimeter of mercury (mm of Hg) | Standard Deviation 9.167 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 28; n= 63, 67 | -0.15 millimeter of mercury (mm of Hg) | Standard Deviation 13.24 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 56; n= 62, 63 | 0.11 millimeter of mercury (mm of Hg) | Standard Deviation 8.899 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 32; n= 62, 67 | 0.04 millimeter of mercury (mm of Hg) | Standard Deviation 11.181 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 16; n= 64, 68 | 0.46 millimeter of mercury (mm of Hg) | Standard Deviation 9.824 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 36; n= 62, 67 | 0.48 millimeter of mercury (mm of Hg) | Standard Deviation 14.397 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 40; n= 62, 66 | -0.03 millimeter of mercury (mm of Hg) | Standard Deviation 8.868 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 40; n= 62, 66 | 1.27 millimeter of mercury (mm of Hg) | Standard Deviation 12.075 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 20; n= 63, 68 | -1.19 millimeter of mercury (mm of Hg) | Standard Deviation 9.214 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 44; n= 61, 66 | -0.36 millimeter of mercury (mm of Hg) | Standard Deviation 13.694 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 52; n= 61, 65 | -0.06 millimeter of mercury (mm of Hg) | Standard Deviation 9.236 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 48; n= 61, 65 | -0.22 millimeter of mercury (mm of Hg) | Standard Deviation 12.351 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 24; n= 63, 67 | -1.16 millimeter of mercury (mm of Hg) | Standard Deviation 9.629 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP: Week 52; n= 61, 65 | -0.32 millimeter of mercury (mm of Hg) | Standard Deviation 13.091 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 44; n= 61, 66 | -1.03 millimeter of mercury (mm of Hg) | Standard Deviation 9.595 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 56; n= 62, 63 | 1.02 millimeter of mercury (mm of Hg) | Standard Deviation 13.559 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | DBP; Week 28; n= 63, 67 | 0.36 millimeter of mercury (mm of Hg) | Standard Deviation 10.071 |
| Mepolizumab 300mg | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Levels | SBP; Week 60; n= 61, 65 | -0.63 millimeter of mercury (mm of Hg) | Standard Deviation 11.656 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Maximum Change From Baseline in QTcF and QTcB Values | QTcB interval | 18.8 msec | Standard Deviation 26.46 |
| Placebo | Maximum Change From Baseline in QTcF and QTcB Values | QTcF interval | 16.9 msec | Standard Deviation 23.74 |
| Mepolizumab 300mg | Maximum Change From Baseline in QTcF and QTcB Values | QTcB interval | 18.1 msec | Standard Deviation 15.28 |
| Mepolizumab 300mg | Maximum Change From Baseline in QTcF and QTcB Values | QTcF interval | 15.4 msec | Standard Deviation 13.79 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 8; n= 66, 66 | 0.1 milliseconds (msec) | Standard Deviation 17.9 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 16; n= 64, 66 | 0.8 milliseconds (msec) | Standard Deviation 15.26 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 24; n= 60, 66 | 2.8 milliseconds (msec) | Standard Deviation 14.43 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 32; n= 61, 66 | 6.2 milliseconds (msec) | Standard Deviation 25.19 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 40; n= 61, 65 | -0.5 milliseconds (msec) | Standard Deviation 15.25 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 52; n= 58, 64 | 2.0 milliseconds (msec) | Standard Deviation 15.96 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 60; n= 58, 63 | 3.0 milliseconds (msec) | Standard Deviation 14.3 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Any time post Baseline; n= 68, 68 | 16.9 milliseconds (msec) | Standard Deviation 23.74 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 8; n= 66, 66 | -0.8 milliseconds (msec) | Standard Deviation 19.05 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 16; n= 64, 66 | -0.1 milliseconds (msec) | Standard Deviation 18.33 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 24; n= 60, 66 | 1.4 milliseconds (msec) | Standard Deviation 17.89 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 32; n= 61, 66 | 5.2 milliseconds (msec) | Standard Deviation 29.63 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 40; n= 61, 65 | -0.6 milliseconds (msec) | Standard Deviation 17.83 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 52; n= 58, 64 | 1.8 milliseconds (msec) | Standard Deviation 17.64 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 60; n= 58, 63 | 1.2 milliseconds (msec) | Standard Deviation 16.56 |
| Placebo | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Any time post Baseline; n= 68, 68 | 18.8 milliseconds (msec) | Standard Deviation 26.46 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Any time post Baseline; n= 68, 68 | 18.1 milliseconds (msec) | Standard Deviation 15.28 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 8; n= 66, 66 | 1.0 milliseconds (msec) | Standard Deviation 15.03 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 8; n= 66, 66 | 0.9 milliseconds (msec) | Standard Deviation 17.31 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 16; n= 64, 66 | 0.2 milliseconds (msec) | Standard Deviation 14.05 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 40; n= 61, 65 | -1.4 milliseconds (msec) | Standard Deviation 18.88 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 24; n= 60, 66 | 1.9 milliseconds (msec) | Standard Deviation 16.66 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 16; n= 64, 66 | -0.9 milliseconds (msec) | Standard Deviation 14.76 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 32; n= 61, 66 | 1.5 milliseconds (msec) | Standard Deviation 17.16 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 60; n= 58, 63 | 2.7 milliseconds (msec) | Standard Deviation 17.27 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 40; n= 61, 65 | -0.3 milliseconds (msec) | Standard Deviation 17.53 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 24; n= 60, 66 | 1.0 milliseconds (msec) | Standard Deviation 18.1 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 52; n= 58, 64 | 3.0 milliseconds (msec) | Standard Deviation 16.04 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 52; n= 58, 64 | 0.7 milliseconds (msec) | Standard Deviation 18.27 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Week 60; n= 58, 63 | 2.9 milliseconds (msec) | Standard Deviation 14.97 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcB; Week 32; n= 61, 66 | 0.0 milliseconds (msec) | Standard Deviation 19.63 |
| Mepolizumab 300mg | Mean Change From Baseline in QT Interval Corrected by Fridericia's Method (QTcF) and QT Interval Corrected by Bazett's Method (QTcB) Values | QTcF; Any time post Baseline; n= 68, 68 | 15.4 milliseconds (msec) | Standard Deviation 13.79 |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | >0 to <12 weeks | 19 Participants |
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | 24 to <36 weeks | 7 Participants |
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | 12 to <24 weeks | 0 Participants |
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | >=36 weeks | 6 Participants |
| Placebo | Number of Participants in Each Category of Accrued Duration of Remission | Zero | 36 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | >=36 weeks | 22 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | Zero | 15 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | >0 to <12 weeks | 15 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | 12 to <24 weeks | 7 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Accrued Duration of Remission | 24 to <36 weeks | 9 Participants |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | Zero | 2 Participants |
| Placebo | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | >0 to <=4.0mg | 3 Participants |
| Placebo | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | >4.0 to <=7.5mg | 18 Participants |
| Placebo | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | >7.5mg | 45 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | >7.5mg | 28 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | Zero | 12 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | >4.0 to <=7.5mg | 10 Participants |
| Mepolizumab 300mg | Number of Participants in Each Category of Average Daily Prednisolone/Prednisone Dose During the Last 4 Weeks of the Study Treatment Period. | >0 to <=4.0mg | 18 Participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | 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 | 2 Participants |
| Mepolizumab 300mg | 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 | 16 Participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | 1 Participants |
| Mepolizumab 300mg | Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period | 13 Participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Participants Who Are in Remission at 36 and 48 Weeks | 7 Participants |
| Mepolizumab 300mg | Number of Participants Who Are in Remission at 36 and 48 Weeks | 28 Participants |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Anti-Mepolizumab Antibodies | Negative | 66 Participants |
| Placebo | Number of Participants With Anti-Mepolizumab Antibodies | Positive | 1 Participants |
| Mepolizumab 300mg | Number of Participants With Anti-Mepolizumab Antibodies | Negative | 65 Participants |
| Mepolizumab 300mg | Number of Participants With Anti-Mepolizumab Antibodies | Positive | 1 Participants |
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Flushing | 0 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Rash pruritic | 0 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection site erythema | 1 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Hypersensitivity | 0 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection site pain | 1 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection related reactions | 0 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection site reaction | 7 Participants |
| Placebo | Number of Participants With Local and Systemic Adverse Events (AEs) | Facial paralysis | 1 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection site reaction | 9 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Facial paralysis | 0 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Flushing | 1 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Hypersensitivity | 1 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Rash pruritic | 1 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection related reactions | 1 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection site bruising | 1 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection site erythema | 1 Participants |
| Mepolizumab 300mg | Number of Participants With Local and Systemic Adverse Events (AEs) | Injection site pain | 0 Participants |
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Time to First EGPA Relapse | 56 Participants |
| Mepolizumab 300mg | Time to First EGPA Relapse | 38 Participants |