Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
Chronic Obstructive Pulmonary Disease (COPD), GSK573719, Pharmacogenetics
Brief summary
The objective of this study is to evaluate the safety and tolerability of GSK573719 Inhalation Powder 125 mcg once-daily over 52 weeks in Japanese subjects with COPD.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) treatment guidelines recommend an incremental approach to pharmacological treatment as the disease state worsens, involving the use of combinations of drug classes with different or complementary mechanisms of action \[Celli, 2004, GOLD 2009\]. As disease progresses from mild to moderate, regular treatment with one or more long-acting bronchodilators is recommended. Inhaled bronchodilators, including beta2 agonists and anticholinergics are included with inhaled corticosteroids (ICS) therapy and are mainstays of therapy in patients diagnosed with COPD. Since GSK573719 Inhalation Powder is expected to be used for chronic management of COPD as long-acting muscarinic antagonist (LAMA), this study is intended to evaluate the safety and tolerability of long-term administration of GSK573719 Inhalation Powder 125 mcg in Japanese patients with COPD at doses possibly used to be in Japan. In this study, patient safety will also be monitored by evaluating pulmonary function and clinical symptoms.
Interventions
DRUGGSK573719
GSK573719 inhalation powder inhaled orally once daily for 52 weeks.
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Outpatient. * A signed and dated written informed consent prior to study participation. * Japanese subjects 40 years of age or older at Visit 1. * Male or female subjects. A female is eligible if she is of: Non-child bearing potential or Child bearing potential agrees to one of the contraceptive methods. * Subjects with a clinical history of COPD in accordance with the definition by COPD domestic guideline. * Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Visit 1. * Subject with a measured post-salbutamol forced expiratory volume/forced vital capacity (FEV1/FVC) ratio of \<70% and Subjects with a measured post-salbutamol FEV1 \<80% of predicted normal values.
Exclusion criteria
(Visit 1): * Women who are pregnant or lactating or are planning on becoming pregnant during the study. * A current diagnosis of asthma. * Known respiratory disorders other than COPD. * Subjects with historical or current evidence of clinically significant abnormalities that are uncontrolled. * A chest X-ray or computed tomography (CT) scan that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. * Allergy or hypersensitivity to muscarinic, beta2-agonist, lactose/milk protein or magnesium stearate or a condition that contraindicates participation. * Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1. * Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1). * An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. * Significantly abnormal finding from clinical chemistry or hematology, tests at Visit 1. * Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. * Regular use (prescribed every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol) via nebulized therapy. * Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. * A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1. * Affiliation with Investigator Site. * Previous use of GSK573719, the GSK573719/GW642444 combination. * Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period | From the first dose of study medication up to 52 weeks | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations. |
| Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period | From the first dose of study medication up to 52 weeks | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit). |
| Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit). |
| Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit). |
| Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit). |
| Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit | Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit). |
| Change From BL in Blood Pressure Throughout the Treatment Period | BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit | Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52. |
| Change From BL in Heart Rate Throughout the Treatment Period | BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit | Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52. |
| Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit | A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) \>500 milliseconds (msec) or an uncorrected QT interval \>600 msec, for participants with Bundle Branch Block QTc \>530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit). |
| Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit). |
| Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit). |
Countries
Japan
Participant flow
Recruitment details
A total of 131 Japanese participants with chronic obstructive pulmonary disease (COPD) who met the eligibility criteria were registered and administration of investigational product was started
Pre-assignment details
Participants entered a 7- to 14-day Run-in Period followed by a 52-week Treatment Period. Follow-up was conducted by a phone call approximately 1 week following the completion of treatment or withdrawal from the trial.
Participants by arm
| Arm | Count |
|---|---|
| UMEC 125 µg QD Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks. | 131 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 14 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | UMEC 125 µg QD |
|---|---|
| Age, Continuous | 69.2 Years STANDARD_DEVIATION 7.77 |
| Gender Female | 3 Participants |
| Gender Male | 128 Participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 71 / 131 |
| serious Total, serious adverse events | 17 / 131 |
Outcome results
Primary
Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. AEs were classified according to intensity based upon the investigators' clinical judgment. The intensity was categorized as: mild (an event that is easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities); moderate (an event that is sufficiently discomforting to interfere with normal everyday activities); or severe (an event that prevents normal everyday activities).
Time frame: From the first dose of study medication up to 52 weeks
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UMEC 125 µg QD | Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period | Any AE, mild | 78 Participants |
| UMEC 125 µg QD | Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period | Any AE, moderate | 18 Participants |
| UMEC 125 µg QD | Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period | Any AE, severe | 9 Participants |
Primary
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of the study medication, whether or not considered related to the study medication. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the study medication. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect, or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Medical or scientific judgment was exercised in deciding whether reporting was appropriate in other situations.
Time frame: From the first dose of study medication up to 52 weeks
Population: Intent-to Treat (ITT) Population: All participants who received at least one dose of the study medication. For participants who withdrew from the study, all available data collected until the time of study discontinuation were included in the ITT analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UMEC 125 µg QD | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period | Any AE | 105 Participants |
| UMEC 125 µg QD | Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period | Any SAE | 17 Participants |
Secondary
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 24, n=121 | 19.9 International Units per Liter (IU/L) | Standard Deviation 10.45 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 36, n=114 | 20.1 International Units per Liter (IU/L) | Standard Deviation 11.94 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 52, n=111 | 20.7 International Units per Liter (IU/L) | Standard Deviation 10.34 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, WD Visit, n=15 | 23.9 International Units per Liter (IU/L) | Standard Deviation 27.36 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 24/WD, n=128 | 20.5 International Units per Liter (IU/L) | Standard Deviation 13.62 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 52/WD, n=126 | 21.1 International Units per Liter (IU/L) | Standard Deviation 13.38 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, BL (Week -2), n=131 | 23.7 International Units per Liter (IU/L) | Standard Deviation 11.72 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 12, n=126 | 23.0 International Units per Liter (IU/L) | Standard Deviation 8.46 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 24, n=121 | 22.2 International Units per Liter (IU/L) | Standard Deviation 7.12 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 36, n=114 | 22.5 International Units per Liter (IU/L) | Standard Deviation 11.72 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 52, n=111 | 23.2 International Units per Liter (IU/L) | Standard Deviation 8.1 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, WD Visit, n=15 | 28.7 International Units per Liter (IU/L) | Standard Deviation 25.04 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 24/WD, n=128 | 23.1 International Units per Liter (IU/L) | Standard Deviation 10.97 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AST, Week 52/WD, n=126 | 23.8 International Units per Liter (IU/L) | Standard Deviation 11.45 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, BL (Week -2), n=131 | 124.8 International Units per Liter (IU/L) | Standard Deviation 71.56 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 12, n=126 | 119.7 International Units per Liter (IU/L) | Standard Deviation 92.39 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 24, n=121 | 117.3 International Units per Liter (IU/L) | Standard Deviation 70.74 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 36, n=114 | 113.8 International Units per Liter (IU/L) | Standard Deviation 70.26 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 52, n=111 | 109.5 International Units per Liter (IU/L) | Standard Deviation 60.1 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, WD Visit, n=15 | 144.7 International Units per Liter (IU/L) | Standard Deviation 147.28 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 24/WD, n=128 | 119.8 International Units per Liter (IU/L) | Standard Deviation 82.66 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatine Kinase, Week 52/WD, n=126 | 113.7 International Units per Liter (IU/L) | Standard Deviation 75.76 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, BL (Week -2), n=131 | 40.1 International Units per Liter (IU/L) | Standard Deviation 38.68 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 12, n=126 | 38.1 International Units per Liter (IU/L) | Standard Deviation 34.09 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 24, n=121 | 39.5 International Units per Liter (IU/L) | Standard Deviation 42.83 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 36, n=114 | 40.0 International Units per Liter (IU/L) | Standard Deviation 44.18 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 52, n=111 | 42.2 International Units per Liter (IU/L) | Standard Deviation 49.47 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, WD Visit, n=15 | 49.5 International Units per Liter (IU/L) | Standard Deviation 77.05 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 24/WD, n=128 | 40.9 International Units per Liter (IU/L) | Standard Deviation 48.86 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | GGT, Week 52/WD, n=126 | 43.1 International Units per Liter (IU/L) | Standard Deviation 53.14 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, BL (Week -2), n=131 | 233.1 International Units per Liter (IU/L) | Standard Deviation 61.19 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 12, n=126 | 239.2 International Units per Liter (IU/L) | Standard Deviation 68.51 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 24, n=121 | 237.5 International Units per Liter (IU/L) | Standard Deviation 63.33 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 36, n=114 | 232.4 International Units per Liter (IU/L) | Standard Deviation 65.73 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 52, n=111 | 235.1 International Units per Liter (IU/L) | Standard Deviation 64.83 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, WD Visit, n=15 | 258.0 International Units per Liter (IU/L) | Standard Deviation 83.49 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 24/WD, n=128 | 239.4 International Units per Liter (IU/L) | Standard Deviation 67.27 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | AP, Week 52/WD, n=126 | 237.8 International Units per Liter (IU/L) | Standard Deviation 67.34 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, BL (Week -2), n=131 | 21.1 International Units per Liter (IU/L) | Standard Deviation 11.25 |
| UMEC 125 µg QD | Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | ALT, Week 12, n=126 | 20.2 International Units per Liter (IU/L) | Standard Deviation 9.7 |
Secondary
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD Visit (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD Visit (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, BL (Week -2), n=131 | 0.62 Percentage of cells in blood | Standard Deviation 0.462 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 12, n=126 | 0.68 Percentage of cells in blood | Standard Deviation 0.494 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 24, n=121 | 0.63 Percentage of cells in blood | Standard Deviation 0.433 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, WD Visit, n=15 | 0.61 Percentage of cells in blood | Standard Deviation 0.516 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 24/WD, n=128 | 0.63 Percentage of cells in blood | Standard Deviation 0.446 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 52/WD, n=126 | 0.63 Percentage of cells in blood | Standard Deviation 0.46 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, BL (Week -2), n=131 | 3.74 Percentage of cells in blood | Standard Deviation 3.573 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 12, n=126 | 3.61 Percentage of cells in blood | Standard Deviation 2.451 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 24, n=121 | 3.74 Percentage of cells in blood | Standard Deviation 3.453 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 36, n=114 | 3.69 Percentage of cells in blood | Standard Deviation 2.903 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 52, n=111 | 3.93 Percentage of cells in blood | Standard Deviation 4.188 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, WD Visit, n=15 | 2.94 Percentage of cells in blood | Standard Deviation 3.715 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 52/WD, n=126 | 3.81 Percentage of cells in blood | Standard Deviation 4.133 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 12, n=126 | 29.53 Percentage of cells in blood | Standard Deviation 7.34 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 36, n=114 | 30.76 Percentage of cells in blood | Standard Deviation 6.84 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 52, n=111 | 29.87 Percentage of cells in blood | Standard Deviation 6.622 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, WD Visit, n=15 | 23.58 Percentage of cells in blood | Standard Deviation 10.609 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 52/WD, n=126 | 29.12 Percentage of cells in blood | Standard Deviation 7.442 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, BL (Week -2), n=131 | 6.35 Percentage of cells in blood | Standard Deviation 1.494 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 12, n=126 | 6.25 Percentage of cells in blood | Standard Deviation 1.516 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 24, n=121 | 6.39 Percentage of cells in blood | Standard Deviation 1.751 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 36, n=114 | 6.25 Percentage of cells in blood | Standard Deviation 1.539 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 52, n=111 | 6.45 Percentage of cells in blood | Standard Deviation 1.727 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, WD Visit, n=15 | 5.83 Percentage of cells in blood | Standard Deviation 2.264 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 52/WD, n=126 | 6.38 Percentage of cells in blood | Standard Deviation 1.8 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, BL (Week -2), n=131 | 58.34 Percentage of cells in blood | Standard Deviation 7.818 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 12, n=126 | 59.93 Percentage of cells in blood | Standard Deviation 8.065 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 24, n=121 | 59.26 Percentage of cells in blood | Standard Deviation 8.273 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 36, n=114 | 58.67 Percentage of cells in blood | Standard Deviation 7.219 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 52, n=111 | 59.11 Percentage of cells in blood | Standard Deviation 7.107 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, WD Visit, n=15 | 67.04 Percentage of cells in blood | Standard Deviation 14.099 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 24/WD, n=128 | 60.16 Percentage of cells in blood | Standard Deviation 9.378 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 52/WD, n=126 | 60.05 Percentage of cells in blood | Standard Deviation 8.565 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 36, n=114 | 0.63 Percentage of cells in blood | Standard Deviation 0.391 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Basophils, Week 52, n=111 | 0.64 Percentage of cells in blood | Standard Deviation 0.455 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 24/WD, n=128 | 3.61 Percentage of cells in blood | Standard Deviation 3.424 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, BL (Week -2), n=131 | 30.96 Percentage of cells in blood | Standard Deviation 7.711 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 24, n=121 | 29.98 Percentage of cells in blood | Standard Deviation 7.214 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Lymphocytes, Week 24/WD, n=128 | 29.26 Percentage of cells in blood | Standard Deviation 8.001 |
| UMEC 125 µg QD | Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL) (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Monocytes, Week 24/WD, n=128 | 6.34 Percentage of cells in blood | Standard Deviation 1.848 |
Secondary
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 24/WD, n=128 | 2.2556 Millimoles per Liter (MMOL/L) | Standard Deviation 0.10334 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, BL (Week -2), n=131 | 103.2 Millimoles per Liter (MMOL/L) | Standard Deviation 2.58 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 24/WD, n=128 | 6.3364 Millimoles per Liter (MMOL/L) | Standard Deviation 1.83801 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, WD Visit, n=15 | 22.9 Millimoles per Liter (MMOL/L) | Standard Deviation 2.09 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Inorganic Phosphorus, Week 52, n=111 | 0.9888 Millimoles per Liter (MMOL/L) | Standard Deviation 0.15944 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, BL (Week -2), n=131 | 2.2804 Millimoles per Liter (MMOL/L) | Standard Deviation 0.09567 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 12, n=126 | 2.2720 Millimoles per Liter (MMOL/L) | Standard Deviation 0.09628 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 24, n=121 | 2.2589 Millimoles per Liter (MMOL/L) | Standard Deviation 0.10287 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 36, n=114 | 2.2505 Millimoles per Liter (MMOL/L) | Standard Deviation 0.09407 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 52, n=111 | 2.2680 Millimoles per Liter (MMOL/L) | Standard Deviation 0.0958 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, WD Visit, n=15 | 2.1923 Millimoles per Liter (MMOL/L) | Standard Deviation 0.09281 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Calcium, Week 52/WD, n=126 | 2.2590 Millimoles per Liter (MMOL/L) | Standard Deviation 0.09822 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 12, n=126 | 103.0 Millimoles per Liter (MMOL/L) | Standard Deviation 2.61 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 24, n=121 | 103.0 Millimoles per Liter (MMOL/L) | Standard Deviation 2.89 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 36, n=114 | 104.2 Millimoles per Liter (MMOL/L) | Standard Deviation 3.26 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 52, n=111 | 104.1 Millimoles per Liter (MMOL/L) | Standard Deviation 2.74 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, WD Visit, n=15 | 104.1 Millimoles per Liter (MMOL/L) | Standard Deviation 4.61 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 24/WD, n=128 | 103.0 Millimoles per Liter (MMOL/L) | Standard Deviation 3.06 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Chloride, Week 52/WD, n=126 | 104.1 Millimoles per Liter (MMOL/L) | Standard Deviation 2.99 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, BL (Week -2), n=131 | 5.9980 Millimoles per Liter (MMOL/L) | Standard Deviation 1.55438 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 12, n=126 | 6.3127 Millimoles per Liter (MMOL/L) | Standard Deviation 1.91203 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 24, n=121 | 6.2735 Millimoles per Liter (MMOL/L) | Standard Deviation 1.75968 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 36, n=114 | 6.6047 Millimoles per Liter (MMOL/L) | Standard Deviation 2.23873 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 52, n=111 | 6.3957 Millimoles per Liter (MMOL/L) | Standard Deviation 1.88553 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, WD Visit, n=15 | 6.9721 Millimoles per Liter (MMOL/L) | Standard Deviation 2.28881 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Glucose, Week 52/WD, n=126 | 6.4643 Millimoles per Liter (MMOL/L) | Standard Deviation 1.93661 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, BL (Week -2), n=131 | 24.7 Millimoles per Liter (MMOL/L) | Standard Deviation 1.95 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 12, n=126 | 24.2 Millimoles per Liter (MMOL/L) | Standard Deviation 1.85 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 24, n=121 | 24.0 Millimoles per Liter (MMOL/L) | Standard Deviation 2.17 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 36, n=114 | 22.6 Millimoles per Liter (MMOL/L) | Standard Deviation 2.18 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 52, n=111 | 22.8 Millimoles per Liter (MMOL/L) | Standard Deviation 2.16 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 24/WD, n=128 | 24.0 Millimoles per Liter (MMOL/L) | Standard Deviation 2.14 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | CO2/HCO3, Week 52/WD, n=126 | 22.8 Millimoles per Liter (MMOL/L) | Standard Deviation 2.14 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, BL (Week -2), n=131 | 4.28 Millimoles per Liter (MMOL/L) | Standard Deviation 0.322 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 12, n=126 | 4.34 Millimoles per Liter (MMOL/L) | Standard Deviation 0.309 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 24, n=121 | 4.32 Millimoles per Liter (MMOL/L) | Standard Deviation 0.359 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 36, n=114 | 4.26 Millimoles per Liter (MMOL/L) | Standard Deviation 0.345 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 52, n=111 | 4.23 Millimoles per Liter (MMOL/L) | Standard Deviation 0.325 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, WD Visit, n=15 | 4.21 Millimoles per Liter (MMOL/L) | Standard Deviation 0.261 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 24/WD, n=128 | 4.31 Millimoles per Liter (MMOL/L) | Standard Deviation 0.355 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Potassium, Week 52/WD, n=126 | 4.23 Millimoles per Liter (MMOL/L) | Standard Deviation 0.317 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, BL (Week -2), n=131 | 141.5 Millimoles per Liter (MMOL/L) | Standard Deviation 1.99 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 12, n=126 | 141.6 Millimoles per Liter (MMOL/L) | Standard Deviation 1.97 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 24, n=121 | 142.0 Millimoles per Liter (MMOL/L) | Standard Deviation 1.98 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 36, n=114 | 141.6 Millimoles per Liter (MMOL/L) | Standard Deviation 1.9 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 52, n=111 | 141.0 Millimoles per Liter (MMOL/L) | Standard Deviation 1.95 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, WD Visit, n=15 | 140.8 Millimoles per Liter (MMOL/L) | Standard Deviation 2.98 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 24/WD, n=128 | 141.9 Millimoles per Liter (MMOL/L) | Standard Deviation 2.17 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Sodium, Week 52/WD, n=126 | 141.0 Millimoles per Liter (MMOL/L) | Standard Deviation 2.09 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Inorganic Phosphorus , BL (Week -2), n=131 | 0.9707 Millimoles per Liter (MMOL/L) | Standard Deviation 0.14747 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Inorganic Phosphorus, Week 12, n=126 | 0.9731 Millimoles per Liter (MMOL/L) | Standard Deviation 0.14204 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Inorganic Phosphorus, Week 24, n=121 | 0.9895 Millimoles per Liter (MMOL/L) | Standard Deviation 0.14258 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Inorganic Phosphorus, Week 36, n=114 | 0.9942 Millimoles per Liter (MMOL/L) | Standard Deviation 0.14571 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Inorganic Phosphorus, WD Visit, n=15 | 0.9687 Millimoles per Liter (MMOL/L) | Standard Deviation 0.18388 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Inorganic Phosphorus, Week 24/WD, n=128 | 0.9853 Millimoles per Liter (MMOL/L) | Standard Deviation 0.14531 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Inorganic Phosphorus, Week 52/WD, n=126 | 0.9864 Millimoles per Liter (MMOL/L) | Standard Deviation 0.16187 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, BL (Week -2), n=131 | 5.2945 Millimoles per Liter (MMOL/L) | Standard Deviation 1.72055 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 12, n=126 | 5.4556 Millimoles per Liter (MMOL/L) | Standard Deviation 1.50863 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 24, n=121 | 5.4072 Millimoles per Liter (MMOL/L) | Standard Deviation 1.44057 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 36, n=114 | 5.4386 Millimoles per Liter (MMOL/L) | Standard Deviation 1.7308 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 52, n=111 | 5.1788 Millimoles per Liter (MMOL/L) | Standard Deviation 1.37133 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, WD Visit, n=15 | 6.2546 Millimoles per Liter (MMOL/L) | Standard Deviation 2.28218 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 24/WD, n=128 | 5.4551 Millimoles per Liter (MMOL/L) | Standard Deviation 1.48499 |
| UMEC 125 µg QD | Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Inorganic Phosphorus, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD | Urea/BUN, Week 52/WD, n=126 | 5.3068 Millimoles per Liter (MMOL/L) | Standard Deviation 1.53642 |
Secondary
Change From BL in Blood Pressure Throughout the Treatment Period
Blood pressure measurements included systolic blood pressure (SBP) and diastolic blood pressure (DBP). Blood pressure was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
Time frame: BL(Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, Week 8, n=127 | 1.6 millimeters of mercury (mmHg) | Standard Deviation 10.4 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, Week 4, n=128 | 2.2 millimeters of mercury (mmHg) | Standard Deviation 12.47 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, Week 8, n=127 | 4.1 millimeters of mercury (mmHg) | Standard Deviation 13.06 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, Week 12, n=126 | 3.3 millimeters of mercury (mmHg) | Standard Deviation 15.14 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, Week 24, n=121 | 2.6 millimeters of mercury (mmHg) | Standard Deviation 15.18 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, Week 36, n=114 | -1.1 millimeters of mercury (mmHg) | Standard Deviation 16.78 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, Week 52, n=111 | -0.5 millimeters of mercury (mmHg) | Standard Deviation 14.95 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, WD Visit, n=17 | -2.4 millimeters of mercury (mmHg) | Standard Deviation 20.96 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, Week 24/WD, n=129 | 2.0 millimeters of mercury (mmHg) | Standard Deviation 16.19 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | SBP, Week 52/WD, n=128 | -0.8 millimeters of mercury (mmHg) | Standard Deviation 15.79 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, Week 4, n=128 | 0.4 millimeters of mercury (mmHg) | Standard Deviation 9.98 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, Week 12, n=126 | 1.2 millimeters of mercury (mmHg) | Standard Deviation 10.63 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, Week 24, n=121 | 1.3 millimeters of mercury (mmHg) | Standard Deviation 9.86 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, Week 36, n=114 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 11.24 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, Week 52, n=111 | -1.3 millimeters of mercury (mmHg) | Standard Deviation 9.29 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, WD Visit, n=17 | -0.4 millimeters of mercury (mmHg) | Standard Deviation 11.5 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, Week 24/WD, n=129 | 0.9 millimeters of mercury (mmHg) | Standard Deviation 10.15 |
| UMEC 125 µg QD | Change From BL in Blood Pressure Throughout the Treatment Period | DBP, Week 52/WD, n=128 | -1.2 millimeters of mercury (mmHg) | Standard Deviation 9.57 |
Secondary
Change From BL in Heart Rate Throughout the Treatment Period
Heart rate was measured in a sitting position after the participant was kept at rest for at least 5 minutes. Change from BL was calculated as the assessment value at the time of interest minus the BL value. The BL value was recorded at Week 0. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD Visit was conducted for participants who completed the Week 24 Visit or withdrew before Week 24. The Week 52/WD Visit was conducted for participants who completed the Week 52 Visit or withdrew before Week 52.
Time frame: BL (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters or at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | WD Visit, n=17 | 7.8 beats per minute | Standard Deviation 30.78 |
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | Week 4, n=128 | 0.1 beats per minute | Standard Deviation 9.36 |
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | Week 8, n=127 | -0.3 beats per minute | Standard Deviation 11.07 |
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | Week 12, n=126 | -1.4 beats per minute | Standard Deviation 9.71 |
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | Week 24, n=121 | -0.1 beats per minute | Standard Deviation 9.42 |
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | Week 36, n=114 | -1.8 beats per minute | Standard Deviation 10.84 |
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | Week 52, n=111 | -0.4 beats per minute | Standard Deviation 9.72 |
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | Week 24/WD, n=129 | 1.0 beats per minute | Standard Deviation 14.17 |
| UMEC 125 µg QD | Change From BL in Heart Rate Throughout the Treatment Period | Week 52/WD, n=128 | 0.7 beats per minute | Standard Deviation 14.46 |
Secondary
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, BL (Week -2), n=131 | 3.577 Micromoles per Liter (µM/L) | Standard Deviation 2.0172 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 12, n=126 | 3.284 Micromoles per Liter (µM/L) | Standard Deviation 1.6699 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 24, n=121 | 3.137 Micromoles per Liter (µM/L) | Standard Deviation 1.5508 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 36, n=114 | 3.450 Micromoles per Liter (µM/L) | Standard Deviation 1.7323 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 52, n=111 | 3.389 Micromoles per Liter (µM/L) | Standard Deviation 1.6783 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, WD Visit, n=15 | 3.192 Micromoles per Liter (µM/L) | Standard Deviation 1.4258 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 24/WD, n=128 | 3.153 Micromoles per Liter (µM/L) | Standard Deviation 1.5539 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Direct Bilirubin, Week 52/WD, n=126 | 3.366 Micromoles per Liter (µM/L) | Standard Deviation 1.6464 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, BL (Week -2), n=131 | 6.305 Micromoles per Liter (µM/L) | Standard Deviation 2.8933 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 12, n=126 | 6.664 Micromoles per Liter (µM/L) | Standard Deviation 2.8271 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 24, n=121 | 6.444 Micromoles per Liter (µM/L) | Standard Deviation 2.8077 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 36, n=114 | 6.975 Micromoles per Liter (µM/L) | Standard Deviation 3.4662 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 52, n=111 | 6.948 Micromoles per Liter (µM/L) | Standard Deviation 3.0176 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, WD Visit, n=15 | 5.814 Micromoles per Liter (µM/L) | Standard Deviation 3.0861 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 24/WD, n=128 | 6.426 Micromoles per Liter (µM/L) | Standard Deviation 2.893 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, BL (Week -2), n=131 | 9.881 Micromoles per Liter (µM/L) | Standard Deviation 4.4353 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 12, n=126 | 9.948 Micromoles per Liter (µM/L) | Standard Deviation 4.072 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 24, n=121 | 9.582 Micromoles per Liter (µM/L) | Standard Deviation 3.9273 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 36, n=114 | 10.425 Micromoles per Liter (µM/L) | Standard Deviation 4.7718 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 52, n=111 | 10.337 Micromoles per Liter (µM/L) | Standard Deviation 4.3954 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, WD Visit, n=15 | 9.006 Micromoles per Liter (µM/L) | Standard Deviation 4.3099 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 24/WD, n=128 | 9.579 Micromoles per Liter (µM/L) | Standard Deviation 4.0337 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Total Bilirubin, Week 52/WD, n=126 | 10.179 Micromoles per Liter (µM/L) | Standard Deviation 4.3896 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, BL (Week -2), n=131 | 73.1088 Micromoles per Liter (µM/L) | Standard Deviation 15.6256 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 24, n=121 | 73.1894 Micromoles per Liter (µM/L) | Standard Deviation 15.82538 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 52, n=111 | 72.3287 Micromoles per Liter (µM/L) | Standard Deviation 14.54036 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, WD Visit, n=15 | 78.0277 Micromoles per Liter (µM/L) | Standard Deviation 26.02168 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 24/WD, n=128 | 73.3789 Micromoles per Liter (µM/L) | Standard Deviation 16.14369 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, BL (Week -2), n=131 | 347.9353 Micromoles per Liter (µM/L) | Standard Deviation 81.78271 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 12, n=126 | 336.5813 Micromoles per Liter (µM/L) | Standard Deviation 78.0663 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 24, n=121 | 346.9011 Micromoles per Liter (µM/L) | Standard Deviation 78.4528 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 36, n=114 | 352.6016 Micromoles per Liter (µM/L) | Standard Deviation 81.62589 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 52, n=111 | 343.4836 Micromoles per Liter (µM/L) | Standard Deviation 67.7914 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, WD Visit, n=15 | 343.3979 Micromoles per Liter (µM/L) | Standard Deviation 96.73417 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 24/WD, n=128 | 344.4264 Micromoles per Liter (µM/L) | Standard Deviation 78.41134 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Uric Acid, Week 52/WD, n=126 | 343.4734 Micromoles per Liter (µM/L) | Standard Deviation 71.35989 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Indirect Bilirubin, Week 52/WD, n=126 | 6.813 Micromoles per Liter (µM/L) | Standard Deviation 3.0358 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 12, n=126 | 73.5965 Micromoles per Liter (µM/L) | Standard Deviation 16.73127 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 36, n=114 | 73.2092 Micromoles per Liter (µM/L) | Standard Deviation 15.29351 |
| UMEC 125 µg QD | Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the WD Visit, Week 24/WD, and Week 52/WD | Creatinine, Week 52/WD, n=126 | 73.0072 Micromoles per Liter (µM/L) | Standard Deviation 16.28875 |
Secondary
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, BL (Week -2), n=131 | 0.222 10^9 cells per Liter (GI/L) | Standard Deviation 0.1808 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 12, n=126 | 0.213 10^9 cells per Liter (GI/L) | Standard Deviation 0.1426 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 24, n=121 | 0.218 10^9 cells per Liter (GI/L) | Standard Deviation 0.1958 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 36, n=114 | 0.215 10^9 cells per Liter (GI/L) | Standard Deviation 0.1542 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 52, n=111 | 0.233 10^9 cells per Liter (GI/L) | Standard Deviation 0.2074 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, WD Visit, n=15 | 0.189 10^9 cells per Liter (GI/L) | Standard Deviation 0.2265 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 24/WD, n=128 | 0.210 10^9 cells per Liter (GI/L) | Standard Deviation 0.1947 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Eosinophils, Week 52/WD, n=126 | 0.228 10^9 cells per Liter (GI/L) | Standard Deviation 0.2093 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, BL (Week -2), n=131 | 3.673 10^9 cells per Liter (GI/L) | Standard Deviation 1.1732 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 24, n=121 | 3.639 10^9 cells per Liter (GI/L) | Standard Deviation 1.2147 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 36, n=114 | 3.576 10^9 cells per Liter (GI/L) | Standard Deviation 1.1978 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 52, n=111 | 3.709 10^9 cells per Liter (GI/L) | Standard Deviation 1.1155 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, WD Visit, n=15 | 4.657 10^9 cells per Liter (GI/L) | Standard Deviation 2.3277 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 24/WD, n=128 | 3.709 10^9 cells per Liter (GI/L) | Standard Deviation 1.4098 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 52/WD, n=126 | 3.821 10^9 cells per Liter (GI/L) | Standard Deviation 1.3405 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, BL (Week -2), n=131 | 228.8 10^9 cells per Liter (GI/L) | Standard Deviation 55.42 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 12, n=126 | 232.1 10^9 cells per Liter (GI/L) | Standard Deviation 57.03 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 24, n=121 | 228.3 10^9 cells per Liter (GI/L) | Standard Deviation 53.74 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 36, n=114 | 224.6 10^9 cells per Liter (GI/L) | Standard Deviation 51.22 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 52, n=111 | 229.3 10^9 cells per Liter (GI/L) | Standard Deviation 52.38 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, WD Visit, n=15 | 217.3 10^9 cells per Liter (GI/L) | Standard Deviation 48.02 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 24/WD, n=128 | 226.9 10^9 cells per Liter (GI/L) | Standard Deviation 54.03 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Platelet Count, Week 52/WD, n=126 | 227.9 10^9 cells per Liter (GI/L) | Standard Deviation 51.85 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, BL (Week -2), n=131 | 6.24 10^9 cells per Liter (GI/L) | Standard Deviation 1.594 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 12, n=126 | 6.13 10^9 cells per Liter (GI/L) | Standard Deviation 1.549 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 24, n=121 | 6.07 10^9 cells per Liter (GI/L) | Standard Deviation 1.544 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 36, n=114 | 6.04 10^9 cells per Liter (GI/L) | Standard Deviation 1.552 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 52, n=111 | 6.23 10^9 cells per Liter (GI/L) | Standard Deviation 1.558 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, WD Visit, n=15 | 6.87 10^9 cells per Liter (GI/L) | Standard Deviation 2.456 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 24/WD, n=128 | 6.08 10^9 cells per Liter (GI/L) | Standard Deviation 1.664 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WBC Count, Week 52/WD, n=126 | 6.31 10^9 cells per Liter (GI/L) | Standard Deviation 1.69 |
| UMEC 125 µg QD | Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Neutrophils, Week 12, n=126 | 3.705 10^9 cells per Liter (GI/L) | Standard Deviation 1.1894 |
Secondary
Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | BL (Week -2), n=131 | 0.4457 Proportion of red blood cells in blood | Standard Deviation 0.03961 |
| UMEC 125 µg QD | Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 12, n=126 | 0.4511 Proportion of red blood cells in blood | Standard Deviation 0.04075 |
| UMEC 125 µg QD | Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 24, n=121 | 0.4513 Proportion of red blood cells in blood | Standard Deviation 0.03895 |
| UMEC 125 µg QD | Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 36, n=114 | 0.4434 Proportion of red blood cells in blood | Standard Deviation 0.03628 |
| UMEC 125 µg QD | Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 52, n=111 | 0.4419 Proportion of red blood cells in blood | Standard Deviation 0.03726 |
| UMEC 125 µg QD | Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | WD Visit, n=15 | 0.4124 Proportion of red blood cells in blood | Standard Deviation 0.04371 |
| UMEC 125 µg QD | Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 24/WD, n=128 | 0.4484 Proportion of red blood cells in blood | Standard Deviation 0.04108 |
| UMEC 125 µg QD | Hematocrit Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Week 52/WD, n=126 | 0.4384 Proportion of red blood cells in blood | Standard Deviation 0.03909 |
Secondary
Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Blood samples were collected for the measurement of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit (conducted for participants who withdrew at any point during the study), Week 24/WD (conducted for participants who completed the Week 24 Visit or withdrew before Week 24), and Week 52/WD (conducted for participants who completed the Week 52 Visit or withdrew before Week 52). The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed for different parameters and at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Hemoglobin, BL (Week -2), n=131 | 146.2 Grams per Liter (G/L) | Standard Deviation 13.66 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Hemoglobin, Week 12, n=126 | 147.4 Grams per Liter (G/L) | Standard Deviation 13.96 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Hemoglobin, Week 24, n=121 | 147.3 Grams per Liter (G/L) | Standard Deviation 13.59 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Hemoglobin, Week 36, n=114 | 145.6 Grams per Liter (G/L) | Standard Deviation 12.39 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Hemoglobin, Week 52, n=111 | 147.8 Grams per Liter (G/L) | Standard Deviation 13.39 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Hemoblobin, WD Visit, n=15 | 134.4 Grams per Liter (G/L) | Standard Deviation 13.92 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Hemoglobin, Week 24/WD, n=128 | 146.5 Grams per Liter (G/L) | Standard Deviation 14.19 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Hemoglobin, Week 52/WD, n=126 | 146.2 Grams per Liter (G/L) | Standard Deviation 14.09 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Albumin, Week 12, n=126 | 42.5 Grams per Liter (G/L) | Standard Deviation 3.06 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Albumin, Week 24, n=121 | 42.3 Grams per Liter (G/L) | Standard Deviation 3.05 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Albumin, Week 36, n=114 | 42.3 Grams per Liter (G/L) | Standard Deviation 2.94 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Albumin, Week 52, n=111 | 42.6 Grams per Liter (G/L) | Standard Deviation 3.06 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Albumin, WD Visit, n=15 | 38.9 Grams per Liter (G/L) | Standard Deviation 3.13 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Albumin, Week 24/WD, n=128 | 42.1 Grams per Liter (G/L) | Standard Deviation 3.18 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Albumin, Week 52/WD, n=126 | 42.2 Grams per Liter (G/L) | Standard Deviation 3.29 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Protein, BL (Week -2), n=131 | 70.4 Grams per Liter (G/L) | Standard Deviation 4.05 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Protein, Week 12, n=126 | 70.9 Grams per Liter (G/L) | Standard Deviation 4.13 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Protein, Week 24, n=121 | 70.8 Grams per Liter (G/L) | Standard Deviation 4.09 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Protein, Week 36, n=114 | 70.0 Grams per Liter (G/L) | Standard Deviation 4.36 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Protein, Week 52, n=111 | 70.4 Grams per Liter (G/L) | Standard Deviation 4.42 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Protein, WD Visit, n=15 | 67.7 Grams per Liter (G/L) | Standard Deviation 4.67 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Protein, Week 24/WD, n=128 | 70.6 Grams per Liter (G/L) | Standard Deviation 4.23 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Total Protein, Week 52/WD, n=126 | 70.1 Grams per Liter (G/L) | Standard Deviation 4.52 |
| UMEC 125 µg QD | Hemoglobin, Albumin, and Total Protein Values at BL (Week -2), Week 12, Week 24, Week 36, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD | Albumin, BL (Week -2), n=131 | 41.9 Grams per Liter (G/L) | Standard Deviation 2.91 |
Secondary
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. An abnormal and significant ECG finding includes the presence of a QT interval corrected for heart rate (QTc interval) \>500 milliseconds (msec) or an uncorrected QT interval \>600 msec, for participants with Bundle Branch Block QTc \>530 msec based on an average QTc value of triplicate ECGs. The study investigator determined if the abnormal ECG finding was CS or NCS. The WD Visit was conducted for participants who withdrew at any point during the study. The Week 24/WD and Week 52/WD Visits were conducted for participants who completed the Week 24 Visit or withdrew before Week 24 and completed the Week 52 Visit or withdrew before Week 52, respectively. The BL value for clinical laboratory tests was the value recorded on Week -2 (Screening Visit).
Time frame: BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD Visit
Population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | BL (Week -2) Abnormal NCS, n=131 | 57 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | BL (Week -2), Abnormal CS, n=131 | 1 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 12, Abnormal NCS, n=126 | 55 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 12, Abnormal CS, n=126 | 0 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 24, Abnormal NCS, n=121 | 50 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 24, Abnormal CS, n=121 | 0 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 36, Abnormal NCS, n=114 | 45 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 36, Abnormal CS, n=114 | 0 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 52, Abnormal NCS, n=111 | 50 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 52, Abnormal CS, n=111 | 0 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | WD Visit, Abnormal NCS, n=16 | 8 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | WD Visit, Abnormal CS, n=16 | 1 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 24/WD, Abnormal NCS, n=128 | 53 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 24/WD, Abnormal CS, n=128 | 1 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 52/WD, Abnormal NCS, n=127 | 58 Participants |
| UMEC 125 µg QD | Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points | Week 52/WD, Abnormal CS, n=127 | 1 Participants |