Trial Outcomes & Findings for Long-term Safety Study for GSK573719/GW642444 in Japanese (NCT NCT01376388)
NCT ID: NCT01376388
Last Updated: 2017-01-09
Results Overview
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. 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/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant 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. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of \>=5%) and SAEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
52 weeks
Results posted on
2017-01-09
Participant Flow
131 participants (par.) comprised the All Subjects Enrolled Population (ASEP; all par. with records in the study database). One par. in the ASEP was withdrawn due to a Good Clinical Practice violation and was thus withdrawn from the Intent-to-Treat Population (comprised of all participants who received at least one dose of study drug; n=130).
Following screening and a 2-week Run-in Period, during which participants were evaluated for Baseline safety and chronic obstructive pulmonary disease (COPD) status, eligible participants entered a 52-week Treatment Period, followed by a Follow-up Period.
Participant milestones
| Measure |
UMEC/VI 125/25 µg
Participants received GSK573719/GW642444 (UMEC/VI) 125/25 micrograms (µg) inhalation powder via a dry powder inhaler (DPI) once daily (OD) in the morning for 52 weeks.
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
112
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
UMEC/VI 125/25 µg
Participants received GSK573719/GW642444 (UMEC/VI) 125/25 micrograms (µg) inhalation powder via a dry powder inhaler (DPI) once daily (OD) in the morning for 52 weeks.
|
|---|---|
|
Overall Study
Adverse Event
|
13
|
|
Overall Study
Lack of Efficacy
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
Baseline Characteristics
Long-term Safety Study for GSK573719/GW642444 in Japanese
Baseline characteristics by cohort
| Measure |
UMEC/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Age, Continuous
|
70.4 Years
STANDARD_DEVIATION 7.86 • n=5 Participants
|
|
Gender
Female
|
10 Participants
n=5 Participants
|
|
Gender
Male
|
120 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
130 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Intent-to-Treat (ITT) Population: all participants who had received at least one dose of study drug
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. 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/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant 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. Refer to the general AE/SAE module for a list of AEs (occuring at a frequency threshold of \>=5%) and SAEs.
Outcome measures
| Measure |
UMEC/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Any AE
|
113 Participants
|
|
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Any SAE
|
16 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: ITT Population
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period
Mild
|
83 Participants
|
|
Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period
Moderate
|
20 Participants
|
|
Number of Participants With AEs Classified by the Indicated Maximum Grade Throughout the Treatment Period
Severe
|
10 Participants
|
SECONDARY outcome
Timeframe: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X" in the category title.
Blood samples were collected for the measurement of the indicated laboratory parameters at following time points: BL (Week -2), Week 12, Week 24, 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Basophils, BL (Week -2), n=130
|
0.54 Percentage of cells in blood
Standard Deviation 0.340
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Basophils, Week 12, n=127
|
0.58 Percentage of cells in blood
Standard Deviation 0.424
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Basophils, Week 24, n=122
|
0.59 Percentage of cells in blood
Standard Deviation 0.386
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Basophils, Week 52, n=112
|
0.60 Percentage of cells in blood
Standard Deviation 0.615
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Basophils, WD Visit, n=10
|
0.35 Percentage of cells in blood
Standard Deviation 0.246
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Basophils, Week 24/WD, n=129
|
0.58 Percentage of cells in blood
Standard Deviation 0.382
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Basophils, Week 52/WD, n=122
|
0.58 Percentage of cells in blood
Standard Deviation 0.597
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, BL (Week -2), n=130
|
3.90 Percentage of cells in blood
Standard Deviation 3.752
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 12, n=127
|
3.73 Percentage of cells in blood
Standard Deviation 3.178
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 24, n=122
|
4.07 Percentage of cells in blood
Standard Deviation 4.694
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 52, n=112
|
3.54 Percentage of cells in blood
Standard Deviation 2.936
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, WD Visit, n=10
|
2.10 Percentage of cells in blood
Standard Deviation 1.662
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 24/WD, n=129
|
3.97 Percentage of cells in blood
Standard Deviation 4.593
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 52/WD, n=122
|
3.42 Percentage of cells in blood
Standard Deviation 2.876
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Lymphocytes, BL (Week -2), n=130
|
29.07 Percentage of cells in blood
Standard Deviation 8.471
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Lymphocytes, Week 12, n=127
|
28.48 Percentage of cells in blood
Standard Deviation 7.703
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Lymphocytes, Week 24, n=122
|
28.40 Percentage of cells in blood
Standard Deviation 8.620
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Lymphocytes, Week 52, n=112
|
28.71 Percentage of cells in blood
Standard Deviation 7.906
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Lymphocytes, WD Visit, n=10
|
21.28 Percentage of cells in blood
Standard Deviation 8.110
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Lymphocytes, Week 24/WD, n=129
|
28.12 Percentage of cells in blood
Standard Deviation 8.636
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Lymphocytes, Week 52/WD, n=122
|
28.10 Percentage of cells in blood
Standard Deviation 8.150
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Monocytes, BL (Week -2), n=130
|
6.15 Percentage of cells in blood
Standard Deviation 1.758
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Monocytes, Week 12, n=127
|
6.33 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 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Monocytes, Week 24, n=122
|
6.27 Percentage of cells in blood
Standard Deviation 1.541
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Monocytes, Week 52, n=112
|
6.20 Percentage of cells in blood
Standard Deviation 1.827
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Monocytes, WD Visit, n=10
|
7.44 Percentage of cells in blood
Standard Deviation 1.290
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Monocytes, Week 24/WD, n=129
|
6.32 Percentage of cells in blood
Standard Deviation 1.541
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Monocytes, Week 52/WD, n=122
|
6.30 Percentage of cells in blood
Standard Deviation 1.818
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, BL (Week -2), n=130
|
60.34 Percentage of cells in blood
Standard Deviation 9.047
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 12, n=127
|
60.88 Percentage of cells in blood
Standard Deviation 8.880
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 24, n=122
|
60.67 Percentage of cells in blood
Standard Deviation 9.595
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 52, n=112
|
60.96 Percentage of cells in blood
Standard Deviation 8.714
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, WD Visit, n=10
|
68.83 Percentage of cells in blood
Standard Deviation 8.296
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 24/WD, n=129
|
61.01 Percentage of cells in blood
Standard Deviation 9.538
|
|
Basophil, Eosinophil, Lymphocyte, Monocyte, and Total Neutrophil Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 52/WD, n=122
|
61.60 Percentage of cells in blood
Standard Deviation 8.915
|
SECONDARY outcome
Timeframe: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by ''n=X'' in the category title.
Blood samples were collected for the measurment of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, BL (Week -2), n=130
|
0.245 10^9 cells/Liter (GI/L)
Standard Deviation 0.2324
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 12, n=127
|
0.225 10^9 cells/Liter (GI/L)
Standard Deviation 0.1815
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 24, n=122
|
0.260 10^9 cells/Liter (GI/L)
Standard Deviation 0.3243
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 52, n=112
|
0.219 10^9 cells/Liter (GI/L)
Standard Deviation 0.1992
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, WD Visit, n=10
|
0.135 10^9 cells/Liter (GI/L)
Standard Deviation 0.1031
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 24/WD, n=129
|
0.254 10^9 cells/Liter (GI/L)
Standard Deviation 0.3171
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Eosinophils, Week 52/WD, n=122
|
0.212 10^9 cells/Liter (GI/L)
Standard Deviation 0.1942
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, BL (Week -2), n=130
|
3.874 10^9 cells/Liter (GI/L)
Standard Deviation 1.2587
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 12, n=127
|
3.798 10^9 cells/Liter (GI/L)
Standard Deviation 1.2169
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 24, n=122
|
3.946 10^9 cells/Liter (GI/L)
Standard Deviation 1.5517
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 52, n=112
|
3.899 10^9 cells/Liter (GI/L)
Standard Deviation 1.5434
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, WD Visit, n=10
|
4.860 10^9 cells/Liter (GI/L)
Standard Deviation 2.0869
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 24/WD, n=129
|
3.953 10^9 cells/Liter (GI/L)
Standard Deviation 1.5326
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Total Neutrophils, Week 52/WD, n=122
|
3.978 10^9 cells/Liter (GI/L)
Standard Deviation 1.6060
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Platelet Count, BL (Week -2), n=130
|
234.3 10^9 cells/Liter (GI/L)
Standard Deviation 54.92
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Platelet Count, Week 12, n=127
|
238.6 10^9 cells/Liter (GI/L)
Standard Deviation 56.35
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Platelet Count, Week 24, n=122
|
239.3 10^9 cells/Liter (GI/L)
Standard Deviation 59.54
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Platelet Count, Week 52, n=112
|
233.8 10^9 cells/Liter (GI/L)
Standard Deviation 58.63
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Platelet Count, WD Visit, n=10
|
232.0 10^9 cells/Liter (GI/L)
Standard Deviation 84.03
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Platelet Count, Week 24/WD, n=129
|
240.0 10^9 cells/Liter (GI/L)
Standard Deviation 60.02
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Platelet Count, Week 52/WD, n=122
|
233.6 10^9 cells/Liter (GI/L)
Standard Deviation 60.65
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
WBC Count, BL (Week -2), n=130
|
6.38 10^9 cells/Liter (GI/L)
Standard Deviation 1.588
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
WBC Count, Week 12, n=127
|
6.18 10^9 cells/Liter (GI/L)
Standard Deviation 1.443
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
WBC Count, Week 24, n=122
|
6.39 10^9 cells/Liter (GI/L)
Standard Deviation 1.803
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
WBC Count, Week 52, n=112
|
6.30 10^9 cells/Liter (GI/L)
Standard Deviation 1.892
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
WBC Count, WD Visit, n=10
|
6.88 10^9 cells/Liter (GI/L)
Standard Deviation 2.203
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
WBC Count, Week 24/WD, n=129
|
6.37 10^9 cells/Liter (GI/L)
Standard Deviation 1.778
|
|
Eosinophil Values, Total Neutrophil Values, Platelet Count, and White Blood Cell (WBC) Count at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
WBC Count, Week 52/WD, n=122
|
6.35 10^9 cells/Liter (GI/L)
Standard Deviation 1.916
|
SECONDARY outcome
Timeframe: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by "n=X" in the category title.
Blood samples were collected for the measurement of hemoglobin, albumin, and total protein at the following time points: BL (Week -2), Week 12, Week 24, 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Hemoglobin, BL (Week -2), n=130
|
145.1 Grams/Liter (G/L)
Standard Deviation 13.35
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Hemoglobin, Week 12, n=127
|
148.2 Grams/Liter (G/L)
Standard Deviation 13.02
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Hemoglobin, Week 24, n=122
|
148.1 Grams/Liter (G/L)
Standard Deviation 13.58
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Hemoglobin, Week 52, n=112
|
148.2 Grams/Liter (G/L)
Standard Deviation 14.02
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Hemoblobin, WD Visit, n=10
|
146.6 Grams/Liter (G/L)
Standard Deviation 12.82
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Hemoglobin, Week 24/WD, n=129
|
148.0 Grams/Liter (G/L)
Standard Deviation 13.53
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Hemoglobin, Week 52/WD, n=122
|
148.0 Grams/Liter (G/L)
Standard Deviation 13.88
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Albumin, BL (Week -2), n=130
|
42.5 Grams/Liter (G/L)
Standard Deviation 2.58
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Albumin, Week 12, n=127
|
42.9 Grams/Liter (G/L)
Standard Deviation 2.44
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Albumin, Week 24, n=122
|
42.4 Grams/Liter (G/L)
Standard Deviation 2.76
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Albumin, Week 52, n=112
|
41.9 Grams/Liter (G/L)
Standard Deviation 2.96
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Albumin, WD Visit, n=10
|
41.3 Grams/Liter (G/L)
Standard Deviation 3.68
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Albumin, Week 24/WD, n=129
|
42.3 Grams/Liter (G/L)
Standard Deviation 2.80
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Albumin, Week 52/WD, n=122
|
41.9 Grams/Liter (G/L)
Standard Deviation 3.01
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Total Protein, BL (Week -2), n=130
|
70.9 Grams/Liter (G/L)
Standard Deviation 4.20
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Total Protein, Week 12, n=127
|
71.8 Grams/Liter (G/L)
Standard Deviation 4.50
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Total Protein, Week 24, n=122
|
71.2 Grams/Liter (G/L)
Standard Deviation 4.20
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Total Protein, Week 52, n=112
|
70.8 Grams/Liter (G/L)
Standard Deviation 4.78
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Total Protein, WD Visit, n=10
|
68.7 Grams/Liter (G/L)
Standard Deviation 5.46
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Total Protein, Week 24/WD, n=129
|
71.0 Grams/Liter (G/L)
Standard Deviation 4.22
|
|
Hemoglobin, Albumin, and Total Protein Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/Withdrawal (WD)
Total Protein, Week 52/WD, n=122
|
70.6 Grams/Liter (G/L)
Standard Deviation 4.85
|
SECONDARY outcome
Timeframe: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by "n=X" in the category title.
Blood samples were collected for the measurement of hematocrit at the following time points: BL (Week -2), Week 12, Week 24, 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
BL (Week -2), n=130
|
0.4460 Proportion
Standard Deviation 0.03857
|
|
Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Week 12, n=127
|
0.4534 Proportion
Standard Deviation 0.03575
|
|
Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Week 24, n=122
|
0.4515 Proportion
Standard Deviation 0.03720
|
|
Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Week 52, n=112
|
0.4517 Proportion
Standard Deviation 0.04063
|
|
Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
WD Visit, n=10
|
0.4473 Proportion
Standard Deviation 0.03970
|
|
Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Week 24/WD, n=129
|
0.4512 Proportion
Standard Deviation 0.03724
|
|
Hematocrit Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the Withdrawal (WD) Visit, Week 24/WD, and Week 52/WD
Week 52/WD, n=122
|
0.4513 Proportion
Standard Deviation 0.04041
|
SECONDARY outcome
Timeframe: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by "n=X" in the category title.
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 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AP, BL (Week -2), n=130
|
242.1 International Units/Liter (IU/L)
Standard Deviation 80.70
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AP, Week 12, n=127
|
250.2 International Units/Liter (IU/L)
Standard Deviation 82.01
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AP, Week 24, n=122
|
257.3 International Units/Liter (IU/L)
Standard Deviation 81.40
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AP, Week 52, n=112
|
247.5 International Units/Liter (IU/L)
Standard Deviation 77.43
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AP, WD Visit, n=10
|
227.7 International Units/Liter (IU/L)
Standard Deviation 74.24
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AP, Week 24/WD, n=129
|
254.2 International Units/Liter (IU/L)
Standard Deviation 80.75
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AP, Week 52/WD, n=122
|
245.9 International Units/Liter (IU/L)
Standard Deviation 77.07
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
ALT, BL (Week -2), n=130
|
20.0 International Units/Liter (IU/L)
Standard Deviation 10.42
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
ALT, Week 12, n=127
|
21.9 International Units/Liter (IU/L)
Standard Deviation 13.19
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
ALT, Week 24, n=122
|
20.8 International Units/Liter (IU/L)
Standard Deviation 13.06
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
ALT, Week 52, n=112
|
21.2 International Units/Liter (IU/L)
Standard Deviation 12.09
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
ALT, WD Visit, n=10
|
31.7 International Units/Liter (IU/L)
Standard Deviation 28.79
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
ALT, Week 24/WD, n=129
|
21.1 International Units/Liter (IU/L)
Standard Deviation 13.56
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
ALT, Week 52/WD, n=122
|
22.0 International Units/Liter (IU/L)
Standard Deviation 14.29
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AST, BL (Week -2), n=130
|
23.4 International Units/Liter (IU/L)
Standard Deviation 7.35
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AST, Week 12, n=127
|
25.0 International Units/Liter (IU/L)
Standard Deviation 8.90
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AST, Week 24, n=122
|
23.9 International Units/Liter (IU/L)
Standard Deviation 9.62
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AST, Week 52, n=112
|
24.3 International Units/Liter (IU/L)
Standard Deviation 8.94
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AST, WD Visit, n=10
|
41.1 International Units/Liter (IU/L)
Standard Deviation 42.05
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AST, Week 24/WD, n=129
|
24.7 International Units/Liter (IU/L)
Standard Deviation 14.48
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
AST, Week 52/WD, n=122
|
25.7 International Units/Liter (IU/L)
Standard Deviation 15.04
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatine Kinase, BL (Week -2), n=130
|
114.1 International Units/Liter (IU/L)
Standard Deviation 59.56
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatine Kinase, Week 12, n=127
|
120.3 International Units/Liter (IU/L)
Standard Deviation 111.89
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatine Kinase, Week 24, n=122
|
100.8 International Units/Liter (IU/L)
Standard Deviation 42.60
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatine Kinase, Week 52, n=112
|
111.3 International Units/Liter (IU/L)
Standard Deviation 59.60
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatine Kinase, WD Visit, n=10
|
387.5 International Units/Liter (IU/L)
Standard Deviation 971.63
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatine Kinase, Week 24/WD, n=129
|
124.0 International Units/Liter (IU/L)
Standard Deviation 271.90
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatine Kinase, Week 52/WD, n=122
|
134.0 International Units/Liter (IU/L)
Standard Deviation 281.54
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
GGT, BL (Week -2), n=130
|
47.1 International Units/Liter (IU/L)
Standard Deviation 54.80
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
GGT, Week 12, n=127
|
49.1 International Units/Liter (IU/L)
Standard Deviation 57.91
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
GGT, Week 24, n=122
|
49.1 International Units/Liter (IU/L)
Standard Deviation 63.21
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
GGT, Week 52, n=112
|
53.9 International Units/Liter (IU/L)
Standard Deviation 78.30
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
GGT, WD Visit, n=10
|
46.3 International Units/Liter (IU/L)
Standard Deviation 26.29
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
GGT, Week 24/WD Visit, n=129
|
49.2 International Units/Liter (IU/L)
Standard Deviation 61.82
|
|
Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Creatine Kinase, and Gamma Glutamyl Transferase (GGT) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
GGT, Week 52/WD Visit, n=122
|
53.3 International Units/Liter (IU/L)
Standard Deviation 75.37
|
SECONDARY outcome
Timeframe: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by "n=X" in the category title.
Blood samples were collected for the measuremnt of the indicated laboratory parameters at the following time points: BL (Week -2), Week 12, Week 24, 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, BL (Week -2), n=130
|
3.736 Micromoles/Liter (µM/L)
Standard Deviation 1.7659
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, Week 12, n=127
|
3.514 Micromoles/Liter (µM/L)
Standard Deviation 1.6731
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, Week 24, n=122
|
3.350 Micromoles/Liter (µM/L)
Standard Deviation 1.4975
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, Week 52, n=112
|
3.680 Micromoles/Liter (µM/L)
Standard Deviation 1.6426
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, WD Visit, n=10
|
3.249 Micromoles/Liter (µM/L)
Standard Deviation 0.5407
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, Week 24/WD, n=129
|
3.340 Micromoles/Liter (µM/L)
Standard Deviation 1.4632
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Direct Bilirubin, Week 52/WD, n=122
|
3.644 Micromoles/Liter (µM/L)
Standard Deviation 1.5846
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Indirect Bilirubin, BL (Week -2), n=130
|
7.064 Micromoles/Liter (µM/L)
Standard Deviation 2.8991
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Indirect Bilirubin, Week 12, n=127
|
6.975 Micromoles/Liter (µM/L)
Standard Deviation 2.7725
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Indirect Bilirubin, Week 24, n=122
|
6.728 Micromoles/Liter (µM/L)
Standard Deviation 2.5424
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Indirect Bilirubin, Week 52, n=112
|
7.008 Micromoles/Liter (µM/L)
Standard Deviation 2.9302
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Indirect Bilirubin, WD Visit, n=10
|
5.985 Micromoles/Liter (µM/L)
Standard Deviation 2.4517
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Indirect Bilirubin, Week 24/WD, n=129
|
6.641 Micromoles/Liter (µM/L)
Standard Deviation 2.5348
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Indirect Bilirubin, Week 52/WD, n=122
|
6.924 Micromoles/Liter (µM/L)
Standard Deviation 2.8987
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Total Bilirubin, BL (Week -2), n=130
|
10.799 Micromoles/Liter (µM/L)
Standard Deviation 4.3585
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Total Bilirubin, Week 12, n=127
|
10.489 Micromoles/Liter (µM/L)
Standard Deviation 4.1067
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Total Bilirubin, Week 24, n=122
|
10.078 Micromoles/Liter (µM/L)
Standard Deviation 3.6643
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Total Bilirubin, Week 52, n=112
|
10.687 Micromoles/Liter (µM/L)
Standard Deviation 4.2603
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Total Bilirubin, WD Visit, n=10
|
9.234 Micromoles/Liter (µM/L)
Standard Deviation 2.8156
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Total Bilirubin, Week 24/WD, n=129
|
9.982 Micromoles/Liter (µM/L)
Standard Deviation 3.6261
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Total Bilirubin, Week 52/WD, n=122
|
10.568 Micromoles/Liter (µM/L)
Standard Deviation 4.1714
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatinine, BL (Week -2), n=130
|
74.3036 Micromoles/Liter (µM/L)
Standard Deviation 19.60971
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatinine, Week 12, n=127
|
74.3047 Micromoles/Liter (µM/L)
Standard Deviation 19.32910
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatinine, Week 24, n=122
|
73.2633 Micromoles/Liter (µM/L)
Standard Deviation 18.90496
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatinine, Week 52, n=112
|
75.6609 Micromoles/Liter (µM/L)
Standard Deviation 18.69402
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatinine, WD Visit, n=10
|
71.8692 Micromoles/Liter (µM/L)
Standard Deviation 10.60022
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatinine, Week 24/WD, n=129
|
73.2692 Micromoles/Liter (µM/L)
Standard Deviation 18.55960
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Creatinine, Week 52/WD, n=122
|
75.3501 Micromoles/Liter (µM/L)
Standard Deviation 18.16682
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Uric Acid, BL (Week -2), n=130
|
357.8408 Micromoles/Liter (µM/L)
Standard Deviation 81.73895
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Uric Acid, Week 12, n=127
|
353.2737 Micromoles/Liter (µM/L)
Standard Deviation 81.17581
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Uric Acid, Week 24, n=122
|
348.2993 Micromoles/Liter (µM/L)
Standard Deviation 80.93244
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Uric Acid, Week 52, n=112
|
353.2687 Micromoles/Liter (µM/L)
Standard Deviation 89.55111
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Uric Acid, WD Visit, n=10
|
343.7944 Micromoles/Liter (µM/L)
Standard Deviation 87.40840
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Uric Acid, Week 24/WD, n=129
|
349.1799 Micromoles/Liter (µM/L)
Standard Deviation 80.95415
|
|
Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, Creatinine, and Uric Acid Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, the WD Visit, Week 24/WD, and Week 52/WD
Uric Acid, Week 52, n=122
|
352.4921 Micromoles/Liter (µM/L)
Standard Deviation 89.06027
|
SECONDARY outcome
Timeframe: BL (Screening visit: Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed for each parameter is indicated by "n=X" in the category title.
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 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, BL (Week -2), n=130
|
2.2954 Millimoles/Liter (MMOL/L)
Standard Deviation 0.09315
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, Week 12, n=127
|
2.2948 Millimoles/Liter (MMOL/L)
Standard Deviation 0.09903
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, Week 24, n=122
|
2.2837 Millimoles/Liter (MMOL/L)
Standard Deviation 0.09096
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, Week 52, n=112
|
2.2765 Millimoles/Liter (MMOL/L)
Standard Deviation 0.09993
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, WD Visit, n=10
|
2.2829 Millimoles/Liter (MMOL/L)
Standard Deviation 0.15878
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, Week 24/WD, n=129
|
2.2842 Millimoles/Liter (MMOL/L)
Standard Deviation 0.09439
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Calcium, Week 52/WD, n=122
|
2.2770 Millimoles/Liter (MMOL/L)
Standard Deviation 0.10506
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Chloride, BL (Week -2), n=130
|
103.7 Millimoles/Liter (MMOL/L)
Standard Deviation 2.65
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Chloride, Week 12, n=127
|
105.7 Millimoles/Liter (MMOL/L)
Standard Deviation 2.51
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Chloride, Week 24, n=122
|
105.7 Millimoles/Liter (MMOL/L)
Standard Deviation 2.70
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Chloride, Week 52, n=112
|
105.5 Millimoles/Liter (MMOL/L)
Standard Deviation 2.93
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Chloride, WD Visit, n=10
|
104.2 Millimoles/Liter (MMOL/L)
Standard Deviation 3.65
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Chloride, Week 24/WD, n=129
|
105.6 Millimoles/Liter (MMOL/L)
Standard Deviation 2.79
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Chloride, Week 52/WD, n=122
|
105.4 Millimoles/Liter (MMOL/L)
Standard Deviation 3.00
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Glucose, BL (Week -2), n=130
|
6.4447 Millimoles/Liter (MMOL/L)
Standard Deviation 1.86640
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Glucose, Week 12, n=127
|
6.3343 Millimoles/Liter (MMOL/L)
Standard Deviation 1.63238
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Glucose, Week 24, n=122
|
6.7313 Millimoles/Liter (MMOL/L)
Standard Deviation 2.20449
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Glucose, Week 52, n=112
|
6.6325 Millimoles/Liter (MMOL/L)
Standard Deviation 1.81891
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Glucose, WD Visit, n=10
|
6.5280 Millimoles/Liter (MMOL/L)
Standard Deviation 1.52070
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Glucose, Week 24/WD, n=129
|
6.7085 Millimoles/Liter (MMOL/L)
Standard Deviation 2.15445
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Glucose, Week 52/WD, n=122
|
6.6239 Millimoles/Liter (MMOL/L)
Standard Deviation 1.79105
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
CO2/HCO3, BL (Week -2), n=130
|
25.7 Millimoles/Liter (MMOL/L)
Standard Deviation 2.32
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
CO2/HCO3, Week 12, n=127
|
25.1 Millimoles/Liter (MMOL/L)
Standard Deviation 2.29
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
CO2/HCO3, Week 24, n=122
|
24.1 Millimoles/Liter (MMOL/L)
Standard Deviation 2.31
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
CO2/HCO3, Week 52, n=112
|
23.8 Millimoles/Liter (MMOL/L)
Standard Deviation 2.18
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
CO2/HCO3, WD Visit, n=10
|
24.3 Millimoles/Liter (MMOL/L)
Standard Deviation 3.50
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
CO2/HCO3, Week 24/WD, n=129
|
24.2 Millimoles/Liter (MMOL/L)
Standard Deviation 2.41
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
CO2/HCO3, Week 52/WD, n=122
|
23.9 Millimoles/Liter (MMOL/L)
Standard Deviation 2.30
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Potassium, BL (Week -2), n=130
|
4.29 Millimoles/Liter (MMOL/L)
Standard Deviation 0.380
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Potassium, Week 12, n=127
|
4.34 Millimoles/Liter (MMOL/L)
Standard Deviation 0.384
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Potassium, Week 24, n=122
|
4.33 Millimoles/Liter (MMOL/L)
Standard Deviation 0.374
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Potassium, Week 52, n=112
|
4.31 Millimoles/Liter (MMOL/L)
Standard Deviation 0.362
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Potassium, WD Visit, n=10
|
4.42 Millimoles/Liter (MMOL/L)
Standard Deviation 0.301
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Potassium, Week 24/WD, n=129
|
4.33 Millimoles/Liter (MMOL/L)
Standard Deviation 0.366
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Potassium, Week 52/WD, n=122
|
4.32 Millimoles/Liter (MMOL/L)
Standard Deviation 0.357
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Sodium, BL (Week -2), n=130
|
141.4 Millimoles/Liter (MMOL/L)
Standard Deviation 2.09
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Sodium, Week 12, n=127
|
142.3 Millimoles/Liter (MMOL/L)
Standard Deviation 1.95
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Sodium, Week 24, n=122
|
142.3 Millimoles/Liter (MMOL/L)
Standard Deviation 2.03
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Sodium, Week 52, n=112
|
141.4 Millimoles/Liter (MMOL/L)
Standard Deviation 2.26
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Sodium, WD Visit, n=10
|
140.4 Millimoles/Liter (MMOL/L)
Standard Deviation 3.72
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Sodium, Week 24/WD, n=129
|
142.2 Millimoles/Liter (MMOL/L)
Standard Deviation 2.21
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Sodium, Week 52/WD, n=122
|
141.4 Millimoles/Liter (MMOL/L)
Standard Deviation 2.41
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Phosphorous Inorganic, BL (Week -2), n=130
|
0.9714 Millimoles/Liter (MMOL/L)
Standard Deviation 0.15901
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Phosphorous Inorganic, Week 12, n=127
|
1.0124 Millimoles/Liter (MMOL/L)
Standard Deviation 0.16447
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Phosphorous Inorganic, Week 24, n=122
|
0.9975 Millimoles/Liter (MMOL/L)
Standard Deviation 0.16216
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Phosphorous Inorganic, Week 52, n=112
|
0.9448 Millimoles/Liter (MMOL/L)
Standard Deviation 0.16492
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Phosphorous Inorganic, WD Visit, n=10
|
0.9913 Millimoles/Liter (MMOL/L)
Standard Deviation 0.17558
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Phosphorous Inorganic, Week 24/WD, n=129
|
0.9985 Millimoles/Liter (MMOL/L)
Standard Deviation 0.16349
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Urea/BUN, BL (Week -2), n=130
|
0.9486 Millimoles/Liter (MMOL/L)
Standard Deviation 0.16555
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Phosphorous Inorganic, Week 52/WD, n=122
|
5.2660 Millimoles/Liter (MMOL/L)
Standard Deviation 1.52578
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Urea/BUN, Week 12, n=127
|
5.4764 Millimoles/Liter (MMOL/L)
Standard Deviation 1.80029
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Urea/BUN, Week 24, n=122
|
5.4998 Millimoles/Liter (MMOL/L)
Standard Deviation 1.50802
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Urea/BUN, Week 52, n=112
|
5.4570 Millimoles/Liter (MMOL/L)
Standard Deviation 1.66582
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Urea/BUN, WD Visit, n=10
|
5.4335 Millimoles/Liter (MMOL/L)
Standard Deviation 2.05521
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Urea/BUN, Week 24/WD, n=129
|
5.4856 Millimoles/Liter (MMOL/L)
Standard Deviation 1.52903
|
|
Calcium, Chloride, Glucose, Carbon Dioxide/Bicarbonate (CO2/HCO3), Potassium, Sodium, Phosphorous Inorganic, and Urea/Blood Urea Nitrogen (Urea/BUN) Values at Baseline (BL; Week -2), Week 12, Week 24, Week 52, WD Visit, Week 24/WD, and Week 52/WD
Urea/BUN, Week 52/WD, n=122
|
5.4551 Millimoles/Liter (MMOL/L)
Standard Deviation 1.69111
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by "n=X" in the category title). Different participants may have been analyzed for different parameters, 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 Baseline was calculated as the assessment value at the time of interest minus the Baseline value. 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Change From Baseline in Blood Pressure
SBP, Week 4, n=128
|
1.1 Millimeters of Mercury (mmHg)
Standard Deviation 12.27
|
|
Change From Baseline in Blood Pressure
SBP, Week 8, n=127
|
2.0 Millimeters of Mercury (mmHg)
Standard Deviation 13.79
|
|
Change From Baseline in Blood Pressure
SBP, Week 12, n=127
|
2.5 Millimeters of Mercury (mmHg)
Standard Deviation 13.62
|
|
Change From Baseline in Blood Pressure
SBP, Week 24, n=122
|
2.7 Millimeters of Mercury (mmHg)
Standard Deviation 14.80
|
|
Change From Baseline in Blood Pressure
SBP, Week 36, n=116
|
-3.3 Millimeters of Mercury (mmHg)
Standard Deviation 13.80
|
|
Change From Baseline in Blood Pressure
SBP, Week 52, n=112
|
0.4 Millimeters of Mercury (mmHg)
Standard Deviation 13.82
|
|
Change From Baseline in Blood Pressure
SBP, WD Visit, n=10
|
-2.3 Millimeters of Mercury (mmHg)
Standard Deviation 18.62
|
|
Change From Baseline in Blood Pressure
SBP, Week 24/WD, n=129
|
2.5 Millimeters of Mercury (mmHg)
Standard Deviation 15.09
|
|
Change From Baseline in Blood Pressure
SBP, Week 52/WD, n=122
|
0.2 Millimeters of Mercury (mmHg)
Standard Deviation 14.19
|
|
Change From Baseline in Blood Pressure
DBP, Week 4, n=128
|
1.0 Millimeters of Mercury (mmHg)
Standard Deviation 9.21
|
|
Change From Baseline in Blood Pressure
DBP, Week 8, n=127
|
1.4 Millimeters of Mercury (mmHg)
Standard Deviation 9.99
|
|
Change From Baseline in Blood Pressure
DBP, Week 12, n=127
|
0.9 Millimeters of Mercury (mmHg)
Standard Deviation 10.71
|
|
Change From Baseline in Blood Pressure
DBP, Week 24, n=122
|
0.9 Millimeters of Mercury (mmHg)
Standard Deviation 10.81
|
|
Change From Baseline in Blood Pressure
DBP, Week 36, n=116
|
-1.5 Millimeters of Mercury (mmHg)
Standard Deviation 11.10
|
|
Change From Baseline in Blood Pressure
DBP, Week 52, n=112
|
0.6 Millimeters of Mercury (mmHg)
Standard Deviation 10.23
|
|
Change From Baseline in Blood Pressure
DBP, WD Visit, n=10
|
-2.0 Millimeters of Mercury (mmHg)
Standard Deviation 11.05
|
|
Change From Baseline in Blood Pressure
DBP, Week 24/WD, n=129
|
0.6 Millimeters of Mercury (mmHg)
Standard Deviation 10.92
|
|
Change From Baseline in Blood Pressure
DBP, Week 52/WD, n=122
|
0.4 Millimeters of Mercury (mmHg)
Standard Deviation 10.28
|
SECONDARY outcome
Timeframe: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 36, Week 52, WD Visit, Week 24/WD, and Week 52/WDPopulation: ITT Population. Only those participants with post-Baseline data available at the indicated time points were analyzed (represented by "n=X" in the category title). Different participants may have been analyzed 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 Baseline was calculated as the assessment value at the time of interest minus the Baseline value. 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/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Change From Baseline in Heart Rate
Week 4, n=128
|
-0.7 Beats per minute
Standard Deviation 10.21
|
|
Change From Baseline in Heart Rate
Week 8, n=127
|
-0.7 Beats per minute
Standard Deviation 9.39
|
|
Change From Baseline in Heart Rate
Week 12, n=127
|
-1.4 Beats per minute
Standard Deviation 10.81
|
|
Change From Baseline in Heart Rate
Week 24, n=122
|
-0.5 Beats per minute
Standard Deviation 10.63
|
|
Change From Baseline in Heart Rate
Week 36, n=116
|
-2.2 Beats per minute
Standard Deviation 10.56
|
|
Change From Baseline in Heart Rate
Week 52, n=112
|
-0.7 Beats per minute
Standard Deviation 10.63
|
|
Change From Baseline in Heart Rate
WD Visit, n=10
|
9.0 Beats per minute
Standard Deviation 10.46
|
|
Change From Baseline in Heart Rate
Week 24/WD, n=129
|
-0.1 Beats per minute
Standard Deviation 10.67
|
|
Change From Baseline in Heart Rate
Week 52/WD, n=122
|
0.1 Beats per minute
Standard Deviation 10.90
|
SECONDARY outcome
Timeframe: Baseline (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 remaining in the study and contributing evaluable data at the indicated time points were analyzed. The number of participants assessed at each time point is indicated by "n=X" in the category title.
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 Baseline value for clinical laboratory tests was the value recorded on Week -2 (Screening visit).
Outcome measures
| Measure |
UMEC/VI 125/25 µg
n=130 Participants
Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
|
|---|---|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
BL (Week -2), Abnormal NCS, n=130
|
45 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
BL (Week -2), Abnormal CS, n=130
|
2 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 12, Abnormal NCS, n=127
|
50 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 12, Abnormal CS, n=127
|
2 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 24, Abnormal NCS, n=122
|
43 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 24, Abnormal CS, n=122
|
3 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 36, Abnormal NCS, n=116
|
45 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 36, Abnormal CS, n=116
|
2 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 52, Abnormal NCS, n=112
|
47 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 52, Abnormal CS, n=112
|
2 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
WD Visit, Abnormal NCS, n=9
|
4 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
WD Visit, Abnormal CS, n=9
|
0 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 24/WD, Abnormal NCS, n=128
|
46 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 24/WD, Abnormal CS, n=128
|
3 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 52/WD, Abnormal NCS, n=121
|
51 Participants
|
|
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points
Week 52/WD, Abnormal CS, n=121
|
2 Participants
|
Adverse Events
GSK573719/GW642444
Serious events: 16 serious events
Other events: 70 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK573719/GW642444
n=130 participants at risk
125/25mcg
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.8%
5/130 • 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
|
0.77%
1/130 • 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
|
0.77%
1/130 • 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%
3/130 • 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
Nasopharyngitis
|
0.77%
1/130 • 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 bacterial
|
0.77%
1/130 • 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
Dysphagia
|
0.77%
1/130 • 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
Inguinal hernia
|
0.77%
1/130 • 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
Radicular cyst
|
0.77%
1/130 • 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
|
0.77%
1/130 • 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)
Malignant ascites
|
0.77%
1/130 • 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)
Metastases to pelvis
|
0.77%
1/130 • 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)
Metastases to spine
|
0.77%
1/130 • 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)
Prostate cancer
|
0.77%
1/130 • 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
Cor pulmonale
|
0.77%
1/130 • 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.
|
|
Eye disorders
Cataract
|
0.77%
1/130 • 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
Sudden death
|
0.77%
1/130 • 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
Multiple injuries
|
0.77%
1/130 • 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
|
0.77%
1/130 • 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.
|
|
Psychiatric disorders
Mania
|
0.77%
1/130 • 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
Shock haemorrhagic
|
0.77%
1/130 • 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 |
GSK573719/GW642444
n=130 participants at risk
125/25mcg
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
37.7%
49/130 • 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
|
10.0%
13/130 • 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%
9/130 • 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
|
5.4%
7/130 • 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