Trial Outcomes & Findings for A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (NCT NCT02020889)
NCT ID: NCT02020889
Last Updated: 2018-01-31
Results Overview
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.
COMPLETED
PHASE3
136 participants
Up to Week 52
2018-01-31
Participant Flow
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.
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.
Participant milestones
| Measure |
Placebo
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
61
|
65
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
Baseline characteristics by cohort
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.2 Years
STANDARD_DEVIATION 14.32 • n=5 Participants
|
48.7 Years
STANDARD_DEVIATION 12.39 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 13.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race customized · American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race customized · Asian - Japanese Heritage
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race customized · Asian - South East Asian Heritage
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race customized · White - Arabic/North African Heritage
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race customized · White - White/Caucasian/European Heritage
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race customized · Mixed Race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Number of Participants in Each Category of Accrued Duration of Remission
Zero
|
55 Participants
|
32 Participants
|
|
Number of Participants in Each Category of Accrued Duration of Remission
>0 to <12 weeks
|
8 Participants
|
8 Participants
|
|
Number of Participants in Each Category of Accrued Duration of Remission
12 to <24 weeks
|
3 Participants
|
9 Participants
|
|
Number of Participants in Each Category of Accrued Duration of Remission
24 to <36 weeks
|
0 Participants
|
10 Participants
|
|
Number of Participants in Each Category of Accrued Duration of Remission
>=36 weeks
|
2 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Week 36 and Week 48Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Number of Participants Who Are in Remission at 36 and 48 Weeks
|
2 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Time to First EGPA Relapse
|
56 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Week 48 and Week52Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
12 Participants
|
|
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
|
18 Participants
|
|
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
|
10 Participants
|
|
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
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Number of Participants Who Achieved Remission Within the First 24 Weeks and Remained in Remission for the Remainder of the Treatment Period
|
1 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Number of Participants in Each Category of Accrued Duration of Remission
Zero
|
36 Participants
|
15 Participants
|
|
Number of Participants in Each Category of Accrued Duration of Remission
>0 to <12 weeks
|
19 Participants
|
15 Participants
|
|
Number of Participants in Each Category of Accrued Duration of Remission
12 to <24 weeks
|
0 Participants
|
7 Participants
|
|
Number of Participants in Each Category of Accrued Duration of Remission
24 to <36 weeks
|
7 Participants
|
9 Participants
|
|
Number of Participants in Each Category of Accrued Duration of Remission
>=36 weeks
|
6 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Week 36 and Week 48Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Number of Participants Who Are in Remission at 36 and 48 Weeks
|
7 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: ITT Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Facial paralysis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Flushing
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Hypersensitivity
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Rash pruritic
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Injection related reactions
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Injection site bruising
|
0 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Injection site erythema
|
1 Participants
|
1 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Injection site pain
|
1 Participants
|
0 Participants
|
|
Number of Participants With Local and Systemic Adverse Events (AEs)
Injection site reaction
|
7 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
-1.7 International Unit per Liter (IU/L)
Standard Deviation 11.56
|
|
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
|
21.3 International Unit per Liter (IU/L)
Standard Deviation 14.22
|
|
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
|
-2.2 International Unit per Liter (IU/L)
Standard Deviation 8.59
|
|
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
|
-1.7 International Unit per Liter (IU/L)
Standard Deviation 10.14
|
|
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
|
-0.7 International Unit per Liter (IU/L)
Standard Deviation 12.65
|
|
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
|
-2.2 International Unit per Liter (IU/L)
Standard Deviation 9.73
|
|
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
|
-1.2 International Unit per Liter (IU/L)
Standard Deviation 12.30
|
|
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
|
-0.2 International Unit per Liter (IU/L)
Standard Deviation 15.77
|
|
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
|
-0.4 International Unit per Liter (IU/L)
Standard Deviation 13.62
|
|
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
|
-2.4 International Unit per Liter (IU/L)
Standard Deviation 11.30
|
|
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
|
-3.0 International Unit per Liter (IU/L)
Standard Deviation 11.66
|
|
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
|
-2.3 International Unit per Liter (IU/L)
Standard Deviation 11.70
|
|
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
|
-2.7 International Unit per Liter (IU/L)
Standard Deviation 9.51
|
|
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
|
-1.6 International Unit per Liter (IU/L)
Standard Deviation 15.47
|
|
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
|
-2.8 International Unit per Liter (IU/L)
Standard Deviation 12.87
|
|
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
|
-3.6 International Unit per Liter (IU/L)
Standard Deviation 12.79
|
|
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
|
-4.7 International Unit per Liter (IU/L)
Standard Deviation 14.11
|
|
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
|
60.4 International Unit per Liter (IU/L)
Standard Deviation 20.90
|
|
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
|
-3.2 International Unit per Liter (IU/L)
Standard Deviation 10.01
|
|
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
|
-1.1 International Unit per Liter (IU/L)
Standard Deviation 12.99
|
|
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
|
-1.1 International Unit per Liter (IU/L)
Standard Deviation 14.61
|
|
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
|
4.4 International Unit per Liter (IU/L)
Standard Deviation 21.90
|
|
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
|
2.8 International Unit per Liter (IU/L)
Standard Deviation 17.64
|
|
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
|
4.9 International Unit per Liter (IU/L)
Standard Deviation 17.17
|
|
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
|
4.4 International Unit per Liter (IU/L)
Standard Deviation 15.83
|
|
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
|
4.8 International Unit per Liter (IU/L)
Standard Deviation 14.71
|
|
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
|
6.2 International Unit per Liter (IU/L)
Standard Deviation 18.43
|
|
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
|
5.1 International Unit per Liter (IU/L)
Standard Deviation 16.53
|
|
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
|
5.1 International Unit per Liter (IU/L)
Standard Deviation 17.56
|
|
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 12.30
|
2.3 International Unit per Liter (IU/L)
Standard Deviation 14.47
|
|
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
|
1.7 International Unit per Liter (IU/L)
Standard Deviation 16.42
|
|
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
|
1.0 International Unit per Liter (IU/L)
Standard Deviation 15.08
|
|
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
|
21.8 International Unit per Liter (IU/L)
Standard Deviation 10.73
|
|
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
|
-1.7 International Unit per Liter (IU/L)
Standard Deviation 8.61
|
|
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
|
-1.0 International Unit per Liter (IU/L)
Standard Deviation 8.21
|
|
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
|
-0.7 International Unit per Liter (IU/L)
Standard Deviation 9.62
|
|
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
|
-0.6 International Unit per Liter (IU/L)
Standard Deviation 7.90
|
|
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
|
-0.6 International Unit per Liter (IU/L)
Standard Deviation 8.49
|
|
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
|
-0.4 International Unit per Liter (IU/L)
Standard Deviation 10.44
|
|
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
|
-0.4 International Unit per Liter (IU/L)
Standard Deviation 10.59
|
|
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
|
-1.3 International Unit per Liter (IU/L)
Standard Deviation 10.67
|
|
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
|
-2.2 International Unit per Liter (IU/L)
Standard Deviation 9.61
|
|
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
|
-1.6 International Unit per Liter (IU/L)
Standard Deviation 8.97
|
|
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
|
-2.4 International Unit per Liter (IU/L)
Standard Deviation 9.02
|
|
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
|
-2.3 International Unit per Liter (IU/L)
Standard Deviation 10.14
|
|
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
|
-3.0 International Unit per Liter (IU/L)
Standard Deviation 10.49
|
|
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
|
-2.8 International Unit per Liter (IU/L)
Standard Deviation 10.64
|
|
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
|
-3.7 International Unit per Liter (IU/L)
Standard Deviation 10.92
|
|
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
|
88.8 International Unit per Liter (IU/L)
Standard Deviation 75.18
|
|
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
|
2.0 International Unit per Liter (IU/L)
Standard Deviation 60.92
|
|
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
|
3.5 International Unit per Liter (IU/L)
Standard Deviation 50.48
|
|
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
|
6.1 International Unit per Liter (IU/L)
Standard Deviation 40.86
|
|
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
|
0.5 International Unit per Liter (IU/L)
Standard Deviation 49.65
|
|
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
|
6.5 International Unit per Liter (IU/L)
Standard Deviation 54.83
|
|
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
|
6.0 International Unit per Liter (IU/L)
Standard Deviation 66.69
|
|
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
|
6.3 International Unit per Liter (IU/L)
Standard Deviation 55.84
|
|
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
|
0.2 International Unit per Liter (IU/L)
Standard Deviation 49.68
|
|
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
|
4.9 International Unit per Liter (IU/L)
Standard Deviation 52.71
|
|
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
|
2.8 International Unit per Liter (IU/L)
Standard Deviation 62.74
|
|
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
|
-2.4 International Unit per Liter (IU/L)
Standard Deviation 62.13
|
|
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
|
-2.6 International Unit per Liter (IU/L)
Standard Deviation 90.09
|
|
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
|
0.2 International Unit per Liter (IU/L)
Standard Deviation 53.45
|
|
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
|
-0.2 International Unit per Liter (IU/L)
Standard Deviation 62.08
|
|
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
|
0.4 International Unit per Liter (IU/L)
Standard Deviation 61.45
|
|
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
|
30.1 International Unit per Liter (IU/L)
Standard Deviation 27.24
|
|
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 11.70
|
-2.0 International Unit per Liter (IU/L)
Standard Deviation 9.68
|
|
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
|
-0.6 International Unit per Liter (IU/L)
Standard Deviation 17.99
|
|
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
|
-1.9 International Unit per Liter (IU/L)
Standard Deviation 18.70
|
|
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
|
-1.5 International Unit per Liter (IU/L)
Standard Deviation 21.36
|
|
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
|
-1.1 International Unit per Liter (IU/L)
Standard Deviation 24.50
|
|
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
|
-3.3 International Unit per Liter (IU/L)
Standard Deviation 22.52
|
|
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
|
-3.1 International Unit per Liter (IU/L)
Standard Deviation 16.86
|
|
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
|
-3.6 International Unit per Liter (IU/L)
Standard Deviation 17.87
|
|
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
|
-4.7 International Unit per Liter (IU/L)
Standard Deviation 14.96
|
|
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
|
-0.3 International Unit per Liter (IU/L)
Standard Deviation 19.75
|
|
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
|
-2.7 International Unit per Liter (IU/L)
Standard Deviation 15.25
|
|
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
|
-3.0 International Unit per Liter (IU/L)
Standard Deviation 16.51
|
|
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
|
-4.2 International Unit per Liter (IU/L)
Standard Deviation 13.53
|
|
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
|
-3.6 International Unit per Liter (IU/L)
Standard Deviation 17.02
|
|
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
|
-5.6 International Unit per Liter (IU/L)
Standard Deviation 15.37
|
|
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
|
179.6 International Unit per Liter (IU/L)
Standard Deviation 38.88
|
|
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
|
-2.3 International Unit per Liter (IU/L)
Standard Deviation 27.80
|
|
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
|
-5.3 International Unit per Liter (IU/L)
Standard Deviation 24.46
|
|
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
|
-7.7 International Unit per Liter (IU/L)
Standard Deviation 25.56
|
|
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
|
-10.6 International Unit per Liter (IU/L)
Standard Deviation 26.12
|
|
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 26.80
|
-13.7 International Unit per Liter (IU/L)
Standard Deviation 25.79
|
|
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
|
-13.5 International Unit per Liter (IU/L)
Standard Deviation 26.99
|
|
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
|
-15.9 International Unit per Liter (IU/L)
Standard Deviation 30.44
|
|
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
|
-17.1 International Unit per Liter (IU/L)
Standard Deviation 24.88
|
|
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
|
-16.2 International Unit per Liter (IU/L)
Standard Deviation 30.54
|
|
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
|
-13.5 International Unit per Liter (IU/L)
Standard Deviation 36.31
|
|
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 33.40
|
-17.0 International Unit per Liter (IU/L)
Standard Deviation 31.37
|
|
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
|
-19.0 International Unit per Liter (IU/L)
Standard Deviation 30.66
|
|
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
|
-17.8 International Unit per Liter (IU/L)
Standard Deviation 33.45
|
|
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
|
-16.0 International Unit per Liter (IU/L)
Standard Deviation 30.87
|
|
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
|
-12.4 International Unit per Liter (IU/L)
Standard Deviation 33.23
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
43.5 gram per liter (g/L)
Standard Deviation 3.01
|
|
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
|
-0.1 gram per liter (g/L)
Standard Deviation 2.16
|
|
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
|
-0.6 gram per liter (g/L)
Standard Deviation 2.72
|
|
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
|
-0.4 gram per liter (g/L)
Standard Deviation 2.64
|
|
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
|
-0.6 gram per liter (g/L)
Standard Deviation 2.54
|
|
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
|
-0.2 gram per liter (g/L)
Standard Deviation 2.92
|
|
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 2.80
|
0.1 gram per liter (g/L)
Standard Deviation 2.72
|
|
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
|
0.1 gram per liter (g/L)
Standard Deviation 2.67
|
|
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
|
-0.1 gram per liter (g/L)
Standard Deviation 2.69
|
|
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
|
0.3 gram per liter (g/L)
Standard Deviation 3.01
|
|
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
|
0.2 gram per liter (g/L)
Standard Deviation 2.82
|
|
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
|
-0.3 gram per liter (g/L)
Standard Deviation 2.87
|
|
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
|
-0.3 gram per liter (g/L)
Standard Deviation 2.77
|
|
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
|
-0.3 gram per liter (g/L)
Standard Deviation 3.10
|
|
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
|
-0.5 gram per liter (g/L)
Standard Deviation 2.88
|
|
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
|
-0.7 gram per liter (g/L)
Standard Deviation 3.04
|
|
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
|
67.3 gram per liter (g/L)
Standard Deviation 4.46
|
|
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 3.00
|
-0.5 gram per liter (g/L)
Standard Deviation 3.19
|
|
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
|
-0.9 gram per liter (g/L)
Standard Deviation 3.60
|
|
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
|
-0.6 gram per liter (g/L)
Standard Deviation 3.30
|
|
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
|
-0.8 gram per liter (g/L)
Standard Deviation 3.93
|
|
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
|
0.1 gram per liter (g/L)
Standard Deviation 4.28
|
|
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
|
0.0 gram per liter (g/L)
Standard Deviation 3.96
|
|
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
|
-0.1 gram per liter (g/L)
Standard Deviation 3.59
|
|
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
|
-0.4 gram per liter (g/L)
Standard Deviation 3.91
|
|
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
|
0.2 gram per liter (g/L)
Standard Deviation 4.45
|
|
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
|
0.1 gram per liter (g/L)
Standard Deviation 3.98
|
|
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
|
-0.6 gram per liter (g/L)
Standard Deviation 4.19
|
|
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
|
-0.5 gram per liter (g/L)
Standard Deviation 4.29
|
|
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
|
-0.4 gram per liter (g/L)
Standard Deviation 4.08
|
|
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
|
-0.5 gram per liter (g/L)
Standard Deviation 4.21
|
|
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
|
-0.7 gram per liter (g/L)
Standard Deviation 4.17
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
0.2 micromole per liter (µmol/L)
Standard Deviation 1.06
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 1.06
|
|
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
|
8.8 micromole per liter (µmol/L)
Standard Deviation 4.10
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 3.48
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 3.50
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 3.27
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 4.14
|
|
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 2.90
|
0.3 micromole per liter (µmol/L)
Standard Deviation 3.57
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 2.71
|
|
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
|
0.3 micromole per liter (µmol/L)
Standard Deviation 4.43
|
|
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
|
-0.1 micromole per liter (µmol/L)
Standard Deviation 3.63
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 4.09
|
|
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
|
-0.3 micromole per liter (µmol/L)
Standard Deviation 3.78
|
|
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 2.50
|
0.1 micromole per liter (µmol/L)
Standard Deviation 3.64
|
|
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
|
-0.1 micromole per liter (µmol/L)
Standard Deviation 3.77
|
|
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
|
0.7 micromole per liter (µmol/L)
Standard Deviation 3.92
|
|
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
|
0.5 micromole per liter (µmol/L)
Standard Deviation 3.24
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 3.42
|
|
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
|
73.00 micromole per liter (µmol/L)
Standard Deviation 12.289
|
|
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
|
2.09 micromole per liter (µmol/L)
Standard Deviation 5.533
|
|
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
|
1.15 micromole per liter (µmol/L)
Standard Deviation 6.737
|
|
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
|
0.34 micromole per liter (µmol/L)
Standard Deviation 7.006
|
|
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
|
2.72 micromole per liter (µmol/L)
Standard Deviation 6.702
|
|
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
|
2.60 micromole per liter (µmol/L)
Standard Deviation 7.739
|
|
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
|
0.06 micromole per liter (µmol/L)
Standard Deviation 6.538
|
|
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
|
1.02 micromole per liter (µmol/L)
Standard Deviation 7.764
|
|
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
|
1.85 micromole per liter (µmol/L)
Standard Deviation 8.589
|
|
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
|
0.40 micromole per liter (µmol/L)
Standard Deviation 7.839
|
|
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
|
0.34 micromole per liter (µmol/L)
Standard Deviation 8.119
|
|
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
|
0.04 micromole per liter (µmol/L)
Standard Deviation 9.070
|
|
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
|
-2.25 micromole per liter (µmol/L)
Standard Deviation 7.398
|
|
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
|
-1.35 micromole per liter (µmol/L)
Standard Deviation 7.182
|
|
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
|
-0.30 micromole per liter (µmol/L)
Standard Deviation 8.695
|
|
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
|
-1.22 micromole per liter (µmol/L)
Standard Deviation 10.896
|
|
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
|
1.9 micromole per liter (µmol/L)
Standard Deviation 0.98
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 0.84
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 0.96
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 1.04
|
|
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
|
-0.1 micromole per liter (µmol/L)
Standard Deviation 1.20
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 1.03
|
|
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 0.90
|
0.0 micromole per liter (µmol/L)
Standard Deviation 0.88
|
|
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 1.20
|
0.2 micromole per liter (µmol/L)
Standard Deviation 1.15
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 0.99
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 1.17
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 0.94
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 1.12
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 1.17
|
|
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 1.10
|
0.1 micromole per liter (µmol/L)
Standard Deviation 1.07
|
|
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
|
6.9 micromole per liter (µmol/L)
Standard Deviation 3.38
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 3.06
|
|
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
|
-0.1 micromole per liter (µmol/L)
Standard Deviation 2.94
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 2.79
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 3.37
|
|
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
|
0.2 micromole per liter (µmol/L)
Standard Deviation 3.00
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 2.37
|
|
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 2.60
|
0.1 micromole per liter (µmol/L)
Standard Deviation 3.71
|
|
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
|
-0.2 micromole per liter (µmol/L)
Standard Deviation 3.02
|
|
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
|
0.0 micromole per liter (µmol/L)
Standard Deviation 3.30
|
|
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
|
-0.2 micromole per liter (µmol/L)
Standard Deviation 3.16
|
|
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
|
0.1 micromole per liter (µmol/L)
Standard Deviation 2.99
|
|
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
|
-0.1 micromole per liter (µmol/L)
Standard Deviation 3.13
|
|
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
|
0.5 micromole per liter (µmol/L)
Standard Deviation 3.32
|
|
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
|
0.4 micromole per liter (µmol/L)
Standard Deviation 2.64
|
|
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
|
-0.1 micromole per liter (µmol/L)
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
-0.790 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
-0.540 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.215 millimoles per liter (mmol/L)
Standard Deviation 0.8079
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
1.066 millimoles per liter (mmol/L)
Standard Deviation 0.1939
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.014 millimoles per liter (mmol/L)
Standard Deviation 0.1833
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.024 millimoles per liter (mmol/L)
Standard Deviation 0.2239
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.019 millimoles per liter (mmol/L)
Standard Deviation 0.2181
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.016 millimoles per liter (mmol/L)
Standard Deviation 0.2205
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.019 millimoles per liter (mmol/L)
Standard Deviation 0.2087
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.007 millimoles per liter (mmol/L)
Standard Deviation 0.2142
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.003 millimoles per liter (mmol/L)
Standard Deviation 0.2539
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.040 millimoles per liter (mmol/L)
Standard Deviation 0.2172
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.023 millimoles per liter (mmol/L)
Standard Deviation 0.2260
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.026 millimoles per liter (mmol/L)
Standard Deviation 0.2213
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.041 millimoles per liter (mmol/L)
Standard Deviation 0.2240
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.020 millimoles per liter (mmol/L)
Standard Deviation 0.2443
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.053 millimoles per liter (mmol/L)
Standard Deviation 0.2988
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.043 millimoles per liter (mmol/L)
Standard Deviation 0.3066
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.007 millimoles per liter (mmol/L)
Standard Deviation 0.2322
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
4.10 millimoles per liter (mmol/L)
Standard Deviation 0.359
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.02 millimoles per liter (mmol/L)
Standard Deviation 0.345
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.02 millimoles per liter (mmol/L)
Standard Deviation 0.323
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.01 millimoles per liter (mmol/L)
Standard Deviation 0.296
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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 0.340
|
0.05 millimoles per liter (mmol/L)
Standard Deviation 0.317
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.01 millimoles per liter (mmol/L)
Standard Deviation 0.372
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.3 millimoles per liter (mmol/L)
Standard Deviation 2.03
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.04 millimoles per liter (mmol/L)
Standard Deviation 0.350
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.10 millimoles per liter (mmol/L)
Standard Deviation 0.382
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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 0.340
|
0.11 millimoles per liter (mmol/L)
Standard Deviation 0.305
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.01 millimoles per liter (mmol/L)
Standard Deviation 0.351
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.14 millimoles per liter (mmol/L)
Standard Deviation 0.313
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.09 millimoles per liter (mmol/L)
Standard Deviation 0.341
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.05 millimoles per liter (mmol/L)
Standard Deviation 0.349
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.01 millimoles per liter (mmol/L)
Standard Deviation 0.329
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.08 millimoles per liter (mmol/L)
Standard Deviation 0.378
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.10 millimoles per liter (mmol/L)
Standard Deviation 0.390
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
140.3 millimoles per liter (mmol/L)
Standard Deviation 1.83
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.2 millimoles per liter (mmol/L)
Standard Deviation 1.89
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.1 millimoles per liter (mmol/L)
Standard Deviation 2.28
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.1 millimoles per liter (mmol/L)
Standard Deviation 1.91
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.1 millimoles per liter (mmol/L)
Standard Deviation 2.09
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.0 millimoles per liter (mmol/L)
Standard Deviation 1.95
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.0 millimoles per liter (mmol/L)
Standard Deviation 2.23
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.1 millimoles per liter (mmol/L)
Standard Deviation 2.13
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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 2.10
|
0.0 millimoles per liter (mmol/L)
Standard Deviation 1.95
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.0 millimoles per liter (mmol/L)
Standard Deviation 2.18
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.2 millimoles per liter (mmol/L)
Standard Deviation 2.02
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.4 millimoles per liter (mmol/L)
Standard Deviation 1.97
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.2 millimoles per liter (mmol/L)
Standard Deviation 2.17
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.5 millimoles per liter (mmol/L)
Standard Deviation 2.08
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.3 millimoles per liter (mmol/L)
Standard Deviation 2.36
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
5.79 millimoles per liter (mmol/L)
Standard Deviation 1.629
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.09 millimoles per liter (mmol/L)
Standard Deviation 1.241
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.20 millimoles per liter (mmol/L)
Standard Deviation 1.206
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.10 millimoles per liter (mmol/L)
Standard Deviation 1.217
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.00 millimoles per liter (mmol/L)
Standard Deviation 1.317
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.23 millimoles per liter (mmol/L)
Standard Deviation 1.286
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.18 millimoles per liter (mmol/L)
Standard Deviation 1.128
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.12 millimoles per liter (mmol/L)
Standard Deviation 1.172
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.22 millimoles per liter (mmol/L)
Standard Deviation 1.350
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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 1.320
|
-0.23 millimoles per liter (mmol/L)
Standard Deviation 1.359
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.32 millimoles per liter (mmol/L)
Standard Deviation 1.391
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.23 millimoles per liter (mmol/L)
Standard Deviation 1.375
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.19 millimoles per liter (mmol/L)
Standard Deviation 1.698
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.09 millimoles per liter (mmol/L)
Standard Deviation 1.429
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.13 millimoles per liter (mmol/L)
Standard Deviation 1.539
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.10 millimoles per liter (mmol/L)
Standard Deviation 1.170
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.646 millimoles per liter (mmol/L)
Standard Deviation 0.2841
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
0.640 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
0.490 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.051 millimoles per liter (mmol/L)
Standard Deviation 0.1927
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
2.382 millimoles per liter (mmol/L)
Standard Deviation 0.1189
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.012 millimoles per liter (mmol/L)
Standard Deviation 0.1200
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.010 millimoles per liter (mmol/L)
Standard Deviation 0.1003
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.026 millimoles per liter (mmol/L)
Standard Deviation 0.0889
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.029 millimoles per liter (mmol/L)
Standard Deviation 0.1018
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.016 millimoles per liter (mmol/L)
Standard Deviation 0.1032
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.013 millimoles per liter (mmol/L)
Standard Deviation 0.1111
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.001 millimoles per liter (mmol/L)
Standard Deviation 0.1039
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.006 millimoles per liter (mmol/L)
Standard Deviation 0.0977
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.006 millimoles per liter (mmol/L)
Standard Deviation 0.1133
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.005 millimoles per liter (mmol/L)
Standard Deviation 0.1115
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.020 millimoles per liter (mmol/L)
Standard Deviation 0.1115
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.018 millimoles per liter (mmol/L)
Standard Deviation 0.1002
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.027 millimoles per liter (mmol/L)
Standard Deviation 0.1110
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.015 millimoles per liter (mmol/L)
Standard Deviation 0.0994
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.019 millimoles per liter (mmol/L)
Standard Deviation 0.1058
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
104.0 millimoles per liter (mmol/L)
Standard Deviation 2.21
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.2 millimoles per liter (mmol/L)
Standard Deviation 2.00
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.5 millimoles per liter (mmol/L)
Standard Deviation 2.06
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.7 millimoles per liter (mmol/L)
Standard Deviation 2.20
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.8 millimoles per liter (mmol/L)
Standard Deviation 1.95
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.7 millimoles per liter (mmol/L)
Standard Deviation 2.04
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.8 millimoles per liter (mmol/L)
Standard Deviation 2.20
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.8 millimoles per liter (mmol/L)
Standard Deviation 2.59
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.5 millimoles per liter (mmol/L)
Standard Deviation 2.32
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.6 millimoles per liter (mmol/L)
Standard Deviation 2.08
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.7 millimoles per liter (mmol/L)
Standard Deviation 2.13
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.21 millimoles per liter (mmol/L)
Standard Deviation 1.740
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.6 millimoles per liter (mmol/L)
Standard Deviation 2.55
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.5 millimoles per liter (mmol/L)
Standard Deviation 2.34
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.4 millimoles per liter (mmol/L)
Standard Deviation 2.24
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.2 millimoles per liter (mmol/L)
Standard Deviation 2.06
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.4 millimoles per liter (mmol/L)
Standard Deviation 2.20
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
5.788 millimoles per liter (mmol/L)
Standard Deviation 1.2386
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available
|
-0.300 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that data was not available
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available
|
-0.300 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that data was not available
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.384 millimoles per liter (mmol/L)
Standard Deviation 0.8798
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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 2.000
|
5.35 millimoles per liter (mmol/L)
Standard Deviation 1.195
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.01 millimoles per liter (mmol/L)
Standard Deviation 1.050
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.07 millimoles per liter (mmol/L)
Standard Deviation 0.986
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.26 millimoles per liter (mmol/L)
Standard Deviation 1.079
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.04 millimoles per liter (mmol/L)
Standard Deviation 1.077
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.03 millimoles per liter (mmol/L)
Standard Deviation 1.351
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.16 millimoles per liter (mmol/L)
Standard Deviation 1.211
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.21 millimoles per liter (mmol/L)
Standard Deviation 1.551
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.14 millimoles per liter (mmol/L)
Standard Deviation 1.162
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.03 millimoles per liter (mmol/L)
Standard Deviation 1.003
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.03 millimoles per liter (mmol/L)
Standard Deviation 1.305
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.05 millimoles per liter (mmol/L)
Standard Deviation 0.891
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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 1.650
|
0.02 millimoles per liter (mmol/L)
Standard Deviation 1.258
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.13 millimoles per liter (mmol/L)
Standard Deviation 1.852
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
0.11 millimoles per liter (mmol/L)
Standard Deviation 1.483
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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 0.4540
|
1.937 millimoles per liter (mmol/L)
Standard Deviation 0.5606
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available
|
-0.150 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that data was not available
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available
|
-0.250 millimoles per liter (mmol/L)
Standard Deviation NA
NA indicates that data was not available
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
-0.150 millimoles per liter (mmol/L)
Standard Deviation 0.3146
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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)
Standard Deviation NA
NA indicates that data was not available.
|
—
|
|
Change From Baseline in Calcium, Chloride, Cholesterol, 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
|
3.205 millimoles per liter (mmol/L)
Standard Deviation 1.0992
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Absolute Troponin; Baseline; n= 68, 68
|
0.013 µg/L
Standard Deviation 0.0110
|
0.013 µg/L
Standard Deviation 0.0092
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 4; n= 68, 66
|
-0.001 µg/L
Standard Deviation 0.0106
|
0.008 µg/L
Standard Deviation 0.0717
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 8; n= 67, 67
|
-0.002 µg/L
Standard Deviation 0.0111
|
0.001 µg/L
Standard Deviation 0.0089
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 12; n= 64, 67
|
-0.002 µg/L
Standard Deviation 0.0108
|
-0.001 µg/L
Standard Deviation 0.0053
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 16; n= 65, 68
|
-0.002 µg/L
Standard Deviation 0.0104
|
0.002 µg/L
Standard Deviation 0.0272
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 20; n= 61, 68
|
-0.002 µg/L
Standard Deviation 0.0105
|
-0.001 µg/L
Standard Deviation 0.0089
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 24; n= 62, 67
|
-0.002 µg/L
Standard Deviation 0.0098
|
0.004 µg/L
Standard Deviation 0.0535
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 28; n= 63, 66
|
-0.003 µg/L
Standard Deviation 0.0102
|
-0.002 µg/L
Standard Deviation 0.0090
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 32; n= 61, 67
|
-0.003 µg/L
Standard Deviation 0.0100
|
-0.002 µg/L
Standard Deviation 0.0092
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 36; n= 61, 67
|
-0.002 µg/L
Standard Deviation 0.0107
|
0.000 µg/L
Standard Deviation 0.0185
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 40; n= 61, 66
|
-0.001 µg/L
Standard Deviation 0.0117
|
-0.002 µg/L
Standard Deviation 0.0090
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 44; n= 61, 65
|
-0.000 µg/L
Standard Deviation 0.0068
|
-0.001 µg/L
Standard Deviation 0.0095
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 48; n= 60, 65
|
0.017 µg/L
Standard Deviation 0.1479
|
-0.001 µg/L
Standard Deviation 0.0101
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 52; n= 60, 65
|
-0.002 µg/L
Standard Deviation 0.0114
|
-0.001 µg/L
Standard Deviation 0.0111
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 56; n= 61, 63
|
-0.003 µg/L
Standard Deviation 0.0112
|
-0.002 µg/L
Standard Deviation 0.0086
|
|
Change From Baseline in Clinical Chemistry Parameter of Troponin Levels
Troponin; Week 60; n= 59, 65
|
-0.003 µg/L
Standard Deviation 0.0109
|
-0.001 µg/L
Standard Deviation 0.0093
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
-0.364 10^9 cells/L
Standard Deviation 0.8540
|
|
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
|
-0.341 10^9 cells/L
Standard Deviation 0.8456
|
|
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
|
-0.351 10^9 cells/L
Standard Deviation 0.8624
|
|
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
|
-0.302 10^9 cells/L
Standard Deviation 0.8352
|
|
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
|
-0.365 10^9 cells/L
Standard Deviation 0.8604
|
|
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
|
0.028 10^9 cells/L
Standard Deviation 0.0236
|
|
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
|
-0.007 10^9 cells/L
Standard Deviation 0.0282
|
|
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
|
-0.002 10^9 cells/L
Standard Deviation 0.0261
|
|
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
|
-0.007 10^9 cells/L
Standard Deviation 0.0222
|
|
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
|
-0.004 10^9 cells/L
Standard Deviation 0.0295
|
|
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
|
-0.002 10^9 cells/L
Standard Deviation 0.0287
|
|
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
|
-0.002 10^9 cells/L
Standard Deviation 0.0328
|
|
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
|
-0.005 10^9 cells/L
Standard Deviation 0.0297
|
|
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
|
0.002 10^9 cells/L
Standard Deviation 0.0355
|
|
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
|
0.005 10^9 cells/L
Standard Deviation 0.0424
|
|
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
|
-0.002 10^9 cells/L
Standard Deviation 0.0356
|
|
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
|
0.000 10^9 cells/L
Standard Deviation 0.0296
|
|
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
|
-0.004 10^9 cells/L
Standard Deviation 0.0300
|
|
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
|
-0.003 10^9 cells/L
Standard Deviation 0.0284
|
|
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
|
-0.003 10^9 cells/L
Standard Deviation 0.0286
|
|
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
|
-0.006 10^9 cells/L
Standard Deviation 0.0248
|
|
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
|
0.398 10^9 cells/L
Standard Deviation 0.8415
|
|
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
|
-0.339 10^9 cells/L
Standard Deviation 0.6794
|
|
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
|
-0.370 10^9 cells/L
Standard Deviation 0.8092
|
|
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
|
-0.364 10^9 cells/L
Standard Deviation 0.8407
|
|
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
|
-0.355 10^9 cells/L
Standard Deviation 0.8280
|
|
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 0.5900
|
-0.347 10^9 cells/L
Standard Deviation 0.8266
|
|
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
|
-0.364 10^9 cells/L
Standard Deviation 0.8211
|
|
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
|
-0.360 10^9 cells/L
Standard Deviation 0.8258
|
|
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
|
-0.347 10^9 cells/L
Standard Deviation 0.8310
|
|
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
|
-0.347 10^9 cells/L
Standard Deviation 0.8388
|
|
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
|
-0.358 10^9 cells/L
Standard Deviation 0.8396
|
|
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
|
9.54 10^9 cells/L
Standard Deviation 3.130
|
|
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
|
-0.77 10^9 cells/L
Standard Deviation 2.356
|
|
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
|
-0.83 10^9 cells/L
Standard Deviation 2.511
|
|
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
|
-1.24 10^9 cells/L
Standard Deviation 2.716
|
|
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
|
-1.16 10^9 cells/L
Standard Deviation 2.827
|
|
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
|
-1.43 10^9 cells/L
Standard Deviation 2.649
|
|
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 2.110
|
-1.47 10^9 cells/L
Standard Deviation 2.738
|
|
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
|
-1.66 10^9 cells/L
Standard Deviation 2.804
|
|
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
|
-1.54 10^9 cells/L
Standard Deviation 2.725
|
|
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
|
-1.37 10^9 cells/L
Standard Deviation 2.578
|
|
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
|
-1.28 10^9 cells/L
Standard Deviation 3.284
|
|
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
|
-1.57 10^9 cells/L
Standard Deviation 2.198
|
|
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
|
-1.46 10^9 cells/L
Standard Deviation 2.546
|
|
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
|
-1.50 10^9 cells/L
Standard Deviation 2.521
|
|
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
|
-1.50 10^9 cells/L
Standard Deviation 2.840
|
|
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
|
-1.20 10^9 cells/L
Standard Deviation 2.396
|
|
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
|
1.508 10^9 cells/L
Standard Deviation 0.8230
|
|
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 0.8990
|
0.145 10^9 cells/L
Standard Deviation 0.7485
|
|
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
|
-0.048 10^9 cells/L
Standard Deviation 0.6388
|
|
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
|
-0.071 10^9 cells/L
Standard Deviation 0.7665
|
|
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
|
0.079 10^9 cells/L
Standard Deviation 0.7254
|
|
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
|
0.127 10^9 cells/L
Standard Deviation 0.7096
|
|
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
|
0.011 10^9 cells/L
Standard Deviation 0.8077
|
|
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
|
0.004 10^9 cells/L
Standard Deviation 0.7328
|
|
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
|
0.031 10^9 cells/L
Standard Deviation 0.7986
|
|
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
|
0.031 10^9 cells/L
Standard Deviation 0.5939
|
|
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
|
0.037 10^9 cells/L
Standard Deviation 0.6391
|
|
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
|
0.059 10^9 cells/L
Standard Deviation 0.6471
|
|
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
|
0.035 10^9 cells/L
Standard Deviation 0.7368
|
|
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
|
0.031 10^9 cells/L
Standard Deviation 0.6244
|
|
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
|
0.128 10^9 cells/L
Standard Deviation 0.7824
|
|
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
|
-0.101 10^9 cells/L
Standard Deviation 0.6848
|
|
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
|
0.405 10^9 cells/L
Standard Deviation 0.2376
|
|
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
|
0.014 10^9 cells/L
Standard Deviation 0.2127
|
|
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
|
0.039 10^9 cells/L
Standard Deviation 0.1988
|
|
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
|
-0.004 10^9 cells/L
Standard Deviation 0.1985
|
|
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 0.2790
|
0.031 10^9 cells/L
Standard Deviation 0.2157
|
|
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
|
0.030 10^9 cells/L
Standard Deviation 0.1967
|
|
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 0.2290
|
0.013 10^9 cells/L
Standard Deviation 0.2412
|
|
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
|
0.035 10^9 cells/L
Standard Deviation 0.2350
|
|
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
|
0.057 10^9 cells/L
Standard Deviation 0.2069
|
|
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
|
0.072 10^9 cells/L
Standard Deviation 0.2416
|
|
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
|
0.050 10^9 cells/L
Standard Deviation 0.2096
|
|
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
|
0.077 10^9 cells/L
Standard Deviation 0.2176
|
|
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
|
0.025 10^9 cells/L
Standard Deviation 0.2235
|
|
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
|
0.024 10^9 cells/L
Standard Deviation 0.2098
|
|
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
|
0.037 10^9 cells/L
Standard Deviation 0.2303
|
|
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 0.2600
|
0.001 10^9 cells/L
Standard Deviation 0.2165
|
|
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
|
7.198 10^9 cells/L
Standard Deviation 2.9732
|
|
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 2.6170
|
-0.583 10^9 cells/L
Standard Deviation 2.2703
|
|
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
|
-0.443 10^9 cells/L
Standard Deviation 2.56476
|
|
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
|
-0.799 10^9 cells/L
Standard Deviation 2.6278
|
|
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
|
-0.914 10^9 cells/L
Standard Deviation 2.6034
|
|
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
|
-1.243 10^9 cells/L
Standard Deviation 2.6857
|
|
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
|
-1.120 10^9 cells/L
Standard Deviation 2.8349
|
|
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
|
-1.335 10^9 cells/L
Standard Deviation 2.9428
|
|
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
|
-1.286 10^9 cells/L
Standard Deviation 2.6995
|
|
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
|
-1.131 10^9 cells/L
Standard Deviation 2.4261
|
|
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
|
-1.010 10^9 cells/L
Standard Deviation 3.3999
|
|
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
|
-1.344 10^9 cells/L
Standard Deviation 2.1031
|
|
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
|
-1.151 10^9 cells/L
Standard Deviation 2.5806
|
|
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
|
-1.211 10^9 cells/L
Standard Deviation 2.2815
|
|
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
|
-1.311 10^9 cells/L
Standard Deviation 3.0024
|
|
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
|
-0.795 10^9 cells/L
Standard Deviation 2.6501
|
|
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
|
270.3 10^9 cells/L
Standard Deviation 60.86
|
|
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
|
-1.4 10^9 cells/L
Standard Deviation 33.79
|
|
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
|
4.1 10^9 cells/L
Standard Deviation 26.48
|
|
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 50.60
|
-4.3 10^9 cells/L
Standard Deviation 37.89
|
|
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 71.20
|
1.8 10^9 cells/L
Standard Deviation 40.25
|
|
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
|
6.1 10^9 cells/L
Standard Deviation 52.76
|
|
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
|
-4.2 10^9 cells/L
Standard Deviation 40.07
|
|
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
|
5.4 10^9 cells/L
Standard Deviation 41.57
|
|
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
|
0.7 10^9 cells/L
Standard Deviation 43.85
|
|
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
|
0.6 10^9 cells/L
Standard Deviation 37.87
|
|
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
|
2.0 10^9 cells/L
Standard Deviation 42.12
|
|
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
|
4.9 10^9 cells/L
Standard Deviation 40.27
|
|
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
|
5.4 10^9 cells/L
Standard Deviation 44.80
|
|
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
|
-3.7 10^9 cells/L
Standard Deviation 46.34
|
|
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
|
-1.0 10^9 cells/L
Standard Deviation 48.51
|
|
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
|
-2.0 10^9 cells/L
Standard Deviation 41.32
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
-1.6 g/L
Standard Deviation 9.22
|
|
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 8.50
|
-0.4 g/L
Standard Deviation 10.23
|
|
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
|
-0.9 g/L
Standard Deviation 9.74
|
|
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
|
-1.9 g/L
Standard Deviation 10.47
|
|
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 8.20
|
-1.9 g/L
Standard Deviation 11.07
|
|
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
|
-1.9 g/L
Standard Deviation 10.36
|
|
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
|
-1.9 g/L
Standard Deviation 11.48
|
|
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
|
-2.4 g/L
Standard Deviation 11.36
|
|
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
|
-1.1 g/L
Standard Deviation 6.28
|
|
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
|
-2.2 g/L
Standard Deviation 7.17
|
|
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
|
-1.9 g/L
Standard Deviation 7.64
|
|
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
|
-1.4 g/L
Standard Deviation 7.64
|
|
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
|
-1.6 g/L
Standard Deviation 8.51
|
|
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
|
-1.3 g/L
Standard Deviation 8.94
|
|
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
|
324.4 g/L
Standard Deviation 7.37
|
|
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
|
-1.1 g/L
Standard Deviation 5.92
|
|
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
|
-1.5 g/L
Standard Deviation 6.86
|
|
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
|
0.3 g/L
Standard Deviation 6.60
|
|
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
|
-2.1 g/L
Standard Deviation 7.88
|
|
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
|
-1.2 g/L
Standard Deviation 7.88
|
|
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
|
-2.6 g/L
Standard Deviation 7.39
|
|
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
|
-2.6 g/L
Standard Deviation 7.33
|
|
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
|
-3.6 g/L
Standard Deviation 7.56
|
|
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
|
-3.3 g/L
Standard Deviation 8.37
|
|
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
|
-3.2 g/L
Standard Deviation 8.96
|
|
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
|
-4.5 g/L
Standard Deviation 9.40
|
|
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
|
-4.8 g/L
Standard Deviation 10.56
|
|
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
|
-5.3 g/L
Standard Deviation 7.72
|
|
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
|
-5.3 g/L
Standard Deviation 7.47
|
|
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
|
-4.7 g/L
Standard Deviation 9.90
|
|
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
|
140.6 g/L
Standard Deviation 12.99
|
|
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
|
-1.8 g/L
Standard Deviation 6.43
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels
Week 12; n= 63, 65
|
0.2 femtoliter (fL)
Standard Deviation 2.00
|
-0.7 femtoliter (fL)
Standard Deviation 2.30
|
|
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
|
94.8 femtoliter (fL)
Standard Deviation 6.14
|
|
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
|
0.0 femtoliter (fL)
Standard Deviation 2.33
|
|
Change From Baseline in Hematology Parameters of Mean Corpuscle Volume (MCV) Levels
Week 8; n= 66, 66
|
0.3 femtoliter (fL)
Standard Deviation 2.50
|
0.0 femtoliter (fL)
Standard Deviation 2.58
|
|
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
|
-0.4 femtoliter (fL)
Standard Deviation 2.94
|
|
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
|
-0.9 femtoliter (fL)
Standard Deviation 2.66
|
|
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
|
-1.0 femtoliter (fL)
Standard Deviation 2.92
|
|
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
|
-1.4 femtoliter (fL)
Standard Deviation 3.48
|
|
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
|
-1.7 femtoliter (fL)
Standard Deviation 3.56
|
|
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
|
-1.9 femtoliter (fL)
Standard Deviation 3.74
|
|
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
|
-1.4 femtoliter (fL)
Standard Deviation 3.73
|
|
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
|
-1.5 femtoliter (fL)
Standard Deviation 3.91
|
|
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
|
-1.5 femtoliter (fL)
Standard Deviation 4.04
|
|
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
|
-1.3 femtoliter (fL)
Standard Deviation 4.29
|
|
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
|
-1.0 femtoliter (fL)
Standard Deviation 4.15
|
|
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
|
-1.0 femtoliter (fL)
Standard Deviation 4.49
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
-0.70 Picogram (pg)
Standard Deviation 1.184
|
|
Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels
Week 12; n= 63, 65
|
-0.04 Picogram (pg)
Standard Deviation 0.550
|
-0.17 Picogram (pg)
Standard Deviation 0.769
|
|
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
|
-0.34 Picogram (pg)
Standard Deviation 0.769
|
|
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
|
-0.88 Picogram (pg)
Standard Deviation 1.368
|
|
Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels
Week 36; n= 60, 66
|
-0.60 Picogram (pg)
Standard Deviation 0.910
|
-0.90 Picogram (pg)
Standard Deviation 1.395
|
|
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
|
-0.79 Picogram (pg)
Standard Deviation 1.390
|
|
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
|
-0.95 Picogram (pg)
Standard Deviation 1.484
|
|
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
|
-0.96 Picogram (pg)
Standard Deviation 1.654
|
|
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
|
-0.95 Picogram (pg)
Standard Deviation 1.585
|
|
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
|
-0.83 Picogram (pg)
Standard Deviation 1.713
|
|
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
|
-0.80 Picogram (pg)
Standard Deviation 1.818
|
|
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
|
-0.41 Picogram (pg)
Standard Deviation 0.851
|
|
Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels
Week 24; n= 62, 66
|
-0.45 Picogram (pg)
Standard Deviation 1.270
|
-0.59 Picogram (pg)
Standard Deviation 0.959
|
|
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
|
30.77 Picogram (pg)
Standard Deviation 2.255
|
|
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
|
-0.12 Picogram (pg)
Standard Deviation 0.785
|
|
Change From Baseline in Hematology Parameters of Mean Corpuscle Hemoglobin (MCH) Levels
Week 8; n= 66, 66
|
-0.02 Picogram (pg)
Standard Deviation 0.950
|
-0.16 Picogram (pg)
Standard Deviation 0.653
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 8; n= 66, 66
|
-0.07 10^12 cells/L
Standard Deviation 0.278
|
-0.01 10^12 cells/L
Standard Deviation 0.211
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 12; n= 63, 65
|
-0.04 10^12 cells/L
Standard Deviation 0.273
|
-0.04 10^12 cells/L
Standard Deviation 0.252
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 16; n= 64, 68
|
-0.02 10^12 cells/L
Standard Deviation 0.266
|
-0.01 10^12 cells/L
Standard Deviation 0.243
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 20; n= 61, 68
|
0.03 10^12 cells/L
Standard Deviation 0.243
|
0.03 10^12 cells/L
Standard Deviation 0.252
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 24; n= 62, 66
|
0.02 10^12 cells/L
Standard Deviation 0.252
|
0.05 10^12 cells/L
Standard Deviation 0.265
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 28; n= 62, 66
|
0.03 10^12 cells/L
Standard Deviation 0.286
|
0.08 10^12 cells/L
Standard Deviation 0.264
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 40; n= 61, 65
|
0.09 10^12 cells/L
Standard Deviation 0.274
|
0.09 10^12 cells/L
Standard Deviation 0.270
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Absolute, Baseline; n= 68, 68
|
4.64 10^12 cells/L
Standard Deviation 0.511
|
4.58 10^12 cells/L
Standard Deviation 0.456
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 4; n= 66, 67
|
-0.07 10^12 cells/L
Standard Deviation 0.228
|
-0.03 10^12 cells/L
Standard Deviation 0.226
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 44; n= 60, 64
|
0.13 10^12 cells/L
Standard Deviation 0.332
|
0.08 10^12 cells/L
Standard Deviation 0.260
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 48; n= 59, 64
|
0.14 10^12 cells/L
Standard Deviation 0.293
|
0.10 10^12 cells/L
Standard Deviation 0.271
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 52; n= 60, 64
|
0.10 10^12 cells/L
Standard Deviation 0.309
|
0.09 10^12 cells/L
Standard Deviation 0.251
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 56; n= 59, 61
|
0.06 10^12 cells/L
Standard Deviation 0.365
|
0.07 10^12 cells/L
Standard Deviation 0.284
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 60; n= 59, 64
|
0.07 10^12 cells/L
Standard Deviation 0.384
|
0.05 10^12 cells/L
Standard Deviation 0.318
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 32; n= 61, 67
|
0.06 10^12 cells/L
Standard Deviation 0.300
|
0.09 10^12 cells/L
Standard Deviation 0.273
|
|
Change From Baseline in Hematology Parameters of Erythrocytes Levels
Week 36; n= 60, 66
|
0.08 10^12 cells/L
Standard Deviation 0.314
|
0.14 10^12 cells/L
Standard Deviation 0.299
|
SECONDARY outcome
Timeframe: Up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=66 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Number of Participants With Anti-Mepolizumab Antibodies
Negative
|
66 Participants
|
65 Participants
|
|
Number of Participants With Anti-Mepolizumab Antibodies
Positive
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
122.46 millimeter of mercury (mm of Hg)
Standard Deviation 14.134
|
|
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
|
1.29 millimeter of mercury (mm of Hg)
Standard Deviation 11.066
|
|
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 14.380
|
-1.41 millimeter of mercury (mm of Hg)
Standard Deviation 12.071
|
|
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 16.630
|
-0.41 millimeter of mercury (mm of Hg)
Standard Deviation 11.579
|
|
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
|
-0.85 millimeter of mercury (mm of Hg)
Standard Deviation 12.019
|
|
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
|
-0.15 millimeter of mercury (mm of Hg)
Standard Deviation 13.240
|
|
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
|
0.04 millimeter of mercury (mm of Hg)
Standard Deviation 11.181
|
|
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
|
0.48 millimeter of mercury (mm of Hg)
Standard Deviation 14.397
|
|
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
|
-0.36 millimeter of mercury (mm of Hg)
Standard Deviation 13.694
|
|
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 17.140
|
-0.22 millimeter of mercury (mm of Hg)
Standard Deviation 12.351
|
|
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
|
1.02 millimeter of mercury (mm of Hg)
Standard Deviation 13.559
|
|
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
|
-0.63 millimeter of mercury (mm of Hg)
Standard Deviation 11.656
|
|
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
|
76.22 millimeter of mercury (mm of Hg)
Standard Deviation 9.646
|
|
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
|
1.01 millimeter of mercury (mm of Hg)
Standard Deviation 10.130
|
|
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
|
-0.37 millimeter of mercury (mm of Hg)
Standard Deviation 9.167
|
|
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
|
0.46 millimeter of mercury (mm of Hg)
Standard Deviation 9.824
|
|
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
|
-1.19 millimeter of mercury (mm of Hg)
Standard Deviation 9.214
|
|
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
|
0.16 millimeter of mercury (mm of Hg)
Standard Deviation 10.988
|
|
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
|
-0.03 millimeter of mercury (mm of Hg)
Standard Deviation 8.868
|
|
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 9.930
|
-1.03 millimeter of mercury (mm of Hg)
Standard Deviation 9.595
|
|
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
|
-1.71 millimeter of mercury (mm of Hg)
Standard Deviation 9.239
|
|
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
|
-0.06 millimeter of mercury (mm of Hg)
Standard Deviation 9.236
|
|
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
|
1.27 millimeter of mercury (mm of Hg)
Standard Deviation 12.075
|
|
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 13.200
|
-0.32 millimeter of mercury (mm of Hg)
Standard Deviation 13.091
|
|
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
|
-0.34 millimeter of mercury (mm of Hg)
Standard Deviation 10.078
|
|
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
|
-1.16 millimeter of mercury (mm of Hg)
Standard Deviation 9.629
|
|
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
|
0.93 millimeter of mercury (mm of Hg)
Standard Deviation 12.370
|
|
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
|
0.36 millimeter of mercury (mm of Hg)
Standard Deviation 10.071
|
|
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
|
-1.57 millimeter of mercury (mm of Hg)
Standard Deviation 12.824
|
|
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
|
-0.49 millimeter of mercury (mm of Hg)
Standard Deviation 10.652
|
|
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 10.570
|
0.11 millimeter of mercury (mm of Hg)
Standard Deviation 8.899
|
|
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
|
-0.45 millimeter of mercury (mm of Hg)
Standard Deviation 9.836
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Change From Baseline in Pulse Rate
Week 16; n= 64, 68
|
0.59 beats per minute (bpm)
Standard Deviation 11.287
|
0.44 beats per minute (bpm)
Standard Deviation 11.411
|
|
Change From Baseline in Pulse Rate
Week 44; n= 61, 66
|
3.10 beats per minute (bpm)
Standard Deviation 12.195
|
0.15 beats per minute (bpm)
Standard Deviation 12.763
|
|
Change From Baseline in Pulse Rate
Week 48; n= 61, 65
|
3.85 beats per minute (bpm)
Standard Deviation 12.383
|
-1.12 beats per minute (bpm)
Standard Deviation 10.315
|
|
Change From Baseline in Pulse Rate
Week 52; n= 61, 65
|
1.85 beats per minute (bpm)
Standard Deviation 11.987
|
-2.17 beats per minute (bpm)
Standard Deviation 9.596
|
|
Change From Baseline in Pulse Rate
Week 56; n= 62, 63
|
2.60 beats per minute (bpm)
Standard Deviation 14.041
|
-0.35 beats per minute (bpm)
Standard Deviation 9.986
|
|
Change From Baseline in Pulse Rate
Week 60; n= 61, 65
|
1.51 beats per minute (bpm)
Standard Deviation 12.793
|
0.09 beats per minute (bpm)
Standard Deviation 10.280
|
|
Change From Baseline in Pulse Rate
Absolute Baseline; n= 68, 68
|
77.38 beats per minute (bpm)
Standard Deviation 13.763
|
75.75 beats per minute (bpm)
Standard Deviation 10.404
|
|
Change From Baseline in Pulse Rate
Week 4; n= 68, 68
|
2.01 beats per minute (bpm)
Standard Deviation 12.294
|
1.87 beats per minute (bpm)
Standard Deviation 10.543
|
|
Change From Baseline in Pulse Rate
Week 8; n= 67, 68
|
0.97 beats per minute (bpm)
Standard Deviation 10.718
|
-1.01 beats per minute (bpm)
Standard Deviation 10.304
|
|
Change From Baseline in Pulse Rate
Week 12; n= 66, 68
|
1.52 beats per minute (bpm)
Standard Deviation 12.393
|
-0.12 beats per minute (bpm)
Standard Deviation 10.855
|
|
Change From Baseline in Pulse Rate
Week 20; n= 63, 68
|
1.03 beats per minute (bpm)
Standard Deviation 11.521
|
-0.56 beats per minute (bpm)
Standard Deviation 9.687
|
|
Change From Baseline in Pulse Rate
Week 24; n= 63, 67
|
0.79 beats per minute (bpm)
Standard Deviation 12.134
|
0.37 beats per minute (bpm)
Standard Deviation 10.057
|
|
Change From Baseline in Pulse Rate
Week 28; n= 62, 67
|
1.29 beats per minute (bpm)
Standard Deviation 10.439
|
0.16 beats per minute (bpm)
Standard Deviation 10.093
|
|
Change From Baseline in Pulse Rate
Week 32; n= 62, 67
|
1.60 beats per minute (bpm)
Standard Deviation 11.703
|
-0.31 beats per minute (bpm)
Standard Deviation 10.530
|
|
Change From Baseline in Pulse Rate
Week 36; n= 62, 67
|
3.47 beats per minute (bpm)
Standard Deviation 12.538
|
-0.57 beats per minute (bpm)
Standard Deviation 11.422
|
|
Change From Baseline in Pulse Rate
Week 40; n= 62, 66
|
2.65 beats per minute (bpm)
Standard Deviation 12.297
|
0.74 beats per minute (bpm)
Standard Deviation 11.669
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Change From Baseline in Body Temperature
Absolute Baseline; n= 68, 68
|
36.52 Degree celsius
Standard Deviation 0.385
|
36.51 Degree celsius
Standard Deviation 0.462
|
|
Change From Baseline in Body Temperature
Week 4; n= 68, 68
|
0.05 Degree celsius
Standard Deviation 0.439
|
-0.04 Degree celsius
Standard Deviation 0.411
|
|
Change From Baseline in Body Temperature
Week 8; n= 67,68
|
-0.01 Degree celsius
Standard Deviation 0.379
|
-0.02 Degree celsius
Standard Deviation 0.425
|
|
Change From Baseline in Body Temperature
Week 12; n= 66, 68
|
0.05 Degree celsius
Standard Deviation 0.410
|
-0.03 Degree celsius
Standard Deviation 0.447
|
|
Change From Baseline in Body Temperature
Week 16; n= 64, 68
|
-0.01 Degree celsius
Standard Deviation 0.421
|
-0.03 Degree celsius
Standard Deviation 0.432
|
|
Change From Baseline in Body Temperature
Week 20; n= 63, 68
|
-0.08 Degree celsius
Standard Deviation 0.351
|
-0.13 Degree celsius
Standard Deviation 0.376
|
|
Change From Baseline in Body Temperature
Week 24; n= 62, 67
|
-0.06 Degree celsius
Standard Deviation 0.449
|
-0.06 Degree celsius
Standard Deviation 0.389
|
|
Change From Baseline in Body Temperature
Week 28; n= 63, 67
|
-0.06 Degree celsius
Standard Deviation 0.499
|
-0.14 Degree celsius
Standard Deviation 0.411
|
|
Change From Baseline in Body Temperature
Week 32; n= 62, 67
|
-0.09 Degree celsius
Standard Deviation 0.392
|
-0.07 Degree celsius
Standard Deviation 0.355
|
|
Change From Baseline in Body Temperature
Week 36; n= 62, 67
|
-0.05 Degree celsius
Standard Deviation 0.431
|
0.03 Degree celsius
Standard Deviation 0.468
|
|
Change From Baseline in Body Temperature
Week 40; n= 62, 66
|
-0.03 Degree celsius
Standard Deviation 0.530
|
-0.13 Degree celsius
Standard Deviation 0.406
|
|
Change From Baseline in Body Temperature
Week 44; n= 61, 65
|
-0.03 Degree celsius
Standard Deviation 0.550
|
-0.08 Degree celsius
Standard Deviation 0.396
|
|
Change From Baseline in Body Temperature
Week 48; n= 61, 64
|
-0.04 Degree celsius
Standard Deviation 0.452
|
-0.09 Degree celsius
Standard Deviation 0.414
|
|
Change From Baseline in Body Temperature
Week 52; n= 60, 65
|
-0.04 Degree celsius
Standard Deviation 0.423
|
-0.12 Degree celsius
Standard Deviation 0.541
|
|
Change From Baseline in Body Temperature
Week 56; n= 61, 63
|
-0.08 Degree celsius
Standard Deviation 0.530
|
-0.00 Degree celsius
Standard Deviation 0.402
|
|
Change From Baseline in Body Temperature
Week 60; n= 61, 64
|
0.03 Degree celsius
Standard Deviation 0.467
|
-0.02 Degree celsius
Standard Deviation 0.479
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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).
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
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
|
1.9 milliseconds (msec)
Standard Deviation 16.66
|
|
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
|
2.7 milliseconds (msec)
Standard Deviation 17.27
|
|
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
|
18.1 milliseconds (msec)
Standard Deviation 15.28
|
|
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 17.90
|
1.0 milliseconds (msec)
Standard Deviation 15.03
|
|
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
|
0.2 milliseconds (msec)
Standard Deviation 14.05
|
|
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
|
1.5 milliseconds (msec)
Standard Deviation 17.16
|
|
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
|
-0.3 milliseconds (msec)
Standard Deviation 17.53
|
|
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
|
3.0 milliseconds (msec)
Standard Deviation 16.04
|
|
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 14.30
|
2.9 milliseconds (msec)
Standard Deviation 14.97
|
|
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
|
15.4 milliseconds (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
QTcB; Week 8; n= 66, 66
|
-0.8 milliseconds (msec)
Standard Deviation 19.05
|
0.9 milliseconds (msec)
Standard Deviation 17.31
|
|
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
|
-0.9 milliseconds (msec)
Standard Deviation 14.76
|
|
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
|
1.0 milliseconds (msec)
Standard Deviation 18.10
|
|
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
|
0.0 milliseconds (msec)
Standard Deviation 19.63
|
|
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
|
-1.4 milliseconds (msec)
Standard Deviation 18.88
|
|
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
|
0.7 milliseconds (msec)
Standard Deviation 18.27
|
SECONDARY outcome
Timeframe: Baseline and up to Week 60Population: Safety Population
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.
Outcome measures
| Measure |
Placebo
n=68 Participants
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 Participants
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Maximum Change From Baseline in QTcF and QTcB Values
QTcB interval
|
18.8 msec
Standard Deviation 26.46
|
18.1 msec
Standard Deviation 15.28
|
|
Maximum Change From Baseline in QTcF and QTcB Values
QTcF interval
|
16.9 msec
Standard Deviation 23.74
|
15.4 msec
Standard Deviation 13.79
|
Adverse Events
Placebo
Mepolizumab 300mg
Serious adverse events
| Measure |
Placebo
n=68 participants at risk
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 participants at risk
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Infections and infestations
Influenza
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Appendicitis
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Corona virus infection
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Herpes zoster
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Lower respiratory infection
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebellar ischaemia
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Facial paralysis
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Lacunar infarction
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Pachymeningitis
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Toxic encephalopathy
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Cardiac disorders
Stress cardiomyopathy
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Hernia
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Allergic granulomatous angiitis
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Testis cancer
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Mental status changes
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Placebo
n=68 participants at risk
Participants received placebo injection via subcutaneous (SC) route once every 4 weeks along with standard of care (SOC) drugs up to Week 48.
|
Mepolizumab 300mg
n=68 participants at risk
Participants received Mepolizumab 300mg injection via SC route once every 4 weeks along with SOC drugs up to Week 48.
|
|---|---|---|
|
Infections and infestations
Fungal skin infection
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Oral herpes
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Otitis media
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Viral infection
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
19.1%
13/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.2%
11/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.8%
8/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
17.6%
12/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
16.2%
11/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Fatigue
|
14.7%
10/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
14.7%
10/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site reaction
|
10.3%
7/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
13.2%
9/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Pyrexia
|
10.3%
7/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
10.3%
7/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Asthenia
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Chest pain
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Injection site pain
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Oedema peripheral
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
17.6%
12/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
22.1%
15/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.2%
9/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
11.8%
8/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
11.8%
8/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
10.3%
7/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
14.7%
10/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
8/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
23.5%
16/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
17.6%
12/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Sinusitis
|
16.2%
11/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
20.6%
14/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.2%
11/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
20.6%
14/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Bronchitis
|
11.8%
8/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
10.3%
7/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Influenza
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
10.3%
7/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
11.8%
8/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Acute sinusitis
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Conjunctivitis
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Rhinitis
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Infections and infestations
Ear infection
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
11.8%
8/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
10.3%
7/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Headache
|
17.6%
12/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
32.4%
22/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Dizziness
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Paraesthesia
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Sinus headache
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Migraine
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
13.2%
9/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
8.8%
6/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Vision blurred
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Cataract
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Vertigo
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
7.4%
5/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Weight increased
|
1.5%
1/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Psychiatric disorders
Insomnia
|
5.9%
4/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
2.9%
2/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
4.4%
3/68 • On-treatment Serious Adverse Events (SAEs) and non-serious Adverse Events (AEs) were collected from the start of the study treatment until week 52.
AEs and SAEs were collected in Safety Population which comprised of all participants who received at least one dose of study treatment.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER