Trial Outcomes & Findings for Long-term Safety Study for GSK573719 in Japanese (NCT NCT01702363)
NCT ID: NCT01702363
Last Updated: 2017-01-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
From the first dose of study medication up to 52 weeks
Results posted on
2017-01-09
Participant Flow
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
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.
Participant milestones
| Measure |
UMEC 125 µg QD
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
131
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
20
|
Reasons for withdrawal
| Measure |
UMEC 125 µg QD
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
Long-term Safety Study for GSK573719 in Japanese
Baseline characteristics by cohort
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
Age, Continuous
|
69.2 Years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
|
Gender
Female
|
3 Participants
n=5 Participants
|
|
Gender
Male
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
131 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study medication up to 52 weeksPopulation: 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.
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.
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period
Any AE
|
105 Participants
|
|
Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) Throughout the Treatment Period
Any SAE
|
17 Participants
|
PRIMARY outcome
Timeframe: From the first dose of study medication up to 52 weeksPopulation: ITT Population
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period
Any AE, mild
|
78 Participants
|
|
Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period
Any AE, moderate
|
18 Participants
|
|
Number of Participants With AEs Classified by the Indicated Maximum Grade Severity Throughout the Treatment Period
Any AE, severe
|
9 Participants
|
SECONDARY outcome
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD VisitPopulation: 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.
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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 7.340
|
|
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
|
|
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
|
|
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
|
|
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 1.800
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.460
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 6.840
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: 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.
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.690
|
SECONDARY outcome
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: 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.
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: 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.
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week36, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: 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.
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 9.70
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 60.10
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 8.10
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: 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.
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 2.8930
|
|
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
|
|
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
|
|
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 4.0720
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 15.62560
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 78.06630
|
|
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 78.45280
|
|
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
|
|
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 67.79140
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: 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.
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 0.09580
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.90
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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 1.73080
|
|
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
|
|
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
|
|
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
|
SECONDARY outcome
Timeframe: 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 VisitPopulation: 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.
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.
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
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
|
|
Change From BL in Blood Pressure Throughout the Treatment Period
DBP, Week 8, n=127
|
1.6 millimeters of mercury (mmHg)
Standard Deviation 10.40
|
|
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
|
|
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
|
|
Change From BL in Blood Pressure Throughout the Treatment Period
DBP, WD Visit, n=17
|
-0.4 millimeters of mercury (mmHg)
Standard Deviation 11.50
|
|
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
|
|
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 outcome
Timeframe: 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 VisitPopulation: 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.
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.
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
Change From BL in Heart Rate Throughout the Treatment Period
Week 4, n=128
|
0.1 beats per minute
Standard Deviation 9.36
|
|
Change From BL in Heart Rate Throughout the Treatment Period
Week 8, n=127
|
-0.3 beats per minute
Standard Deviation 11.07
|
|
Change From BL in Heart Rate Throughout the Treatment Period
WD Visit, n=17
|
7.8 beats per minute
Standard Deviation 30.78
|
|
Change From BL in Heart Rate Throughout the Treatment Period
Week 12, n=126
|
-1.4 beats per minute
Standard Deviation 9.71
|
|
Change From BL in Heart Rate Throughout the Treatment Period
Week 24, n=121
|
-0.1 beats per minute
Standard Deviation 9.42
|
|
Change From BL in Heart Rate Throughout the Treatment Period
Week 36, n=114
|
-1.8 beats per minute
Standard Deviation 10.84
|
|
Change From BL in Heart Rate Throughout the Treatment Period
Week 52, n=111
|
-0.4 beats per minute
Standard Deviation 9.72
|
|
Change From BL in Heart Rate Throughout the Treatment Period
Week 24/WD, n=129
|
1.0 beats per minute
Standard Deviation 14.17
|
|
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 outcome
Timeframe: BL (Screening Visit: Week -2), Week 12, Week 24,Week 36, Week 52, WD Visit, Week 24/WD Visit, and Week 52/WD VisitPopulation: 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.
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).
Outcome measures
| Measure |
UMEC 125 µg QD
n=131 Participants
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
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
|
|
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
|
|
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
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Week 12, Abnormal NCS, n=126
|
55 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Week 12, Abnormal CS, n=126
|
0 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Week 24, Abnormal NCS, n=121
|
50 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Week 24, Abnormal CS, n=121
|
0 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Week 36, Abnormal NCS, n=114
|
45 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Week 36, Abnormal CS, n=114
|
0 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Week 52, Abnormal NCS, n=111
|
50 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
Week 52, Abnormal CS, n=111
|
0 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
WD Visit, Abnormal NCS, n=16
|
8 Participants
|
|
Number of Participants With Abnormal Findings in 12-lead Electrocardiograms (ECG) at the Indicated Time Points
WD Visit, Abnormal CS, n=16
|
1 Participants
|
|
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
|
|
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
|
|
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
|
Adverse Events
UMEC 125 µg QD
Serious events: 17 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
UMEC 125 µg QD
n=131 participants at risk
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
2.3%
3/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
3/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Nervous system disorders
Cerebellar haemorrhage
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
General disorders
Hypothermia
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.76%
1/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
Other adverse events
| Measure |
UMEC 125 µg QD
n=131 participants at risk
Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
32.1%
42/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
7.6%
10/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
6.9%
9/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
6.9%
9/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
8.4%
11/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.6%
10/131 • Serious adverse events (SAEs) and non-serious AEs were collected from the start of study medication until Follow-up (up to 53 weeks).
SAEs and non-serious AEs were collected in members of the ITT Population, comprised of all participants who had received one dose of study drug.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER