Trial Outcomes & Findings for A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01316887)
NCT ID: NCT01316887
Last Updated: 2018-05-02
Results Overview
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the 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, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
563 participants
Primary outcome timeframe
From the start of study drug up to 52 weeks
Results posted on
2018-05-02
Participant Flow
The study consisted of a Run-in Period of 7 to10 days, followed by a 52-week Treatment Period. A total of 893 participants were screened; of these, 312 were screen failures, 19 were Run-in failures, 563 were randomized, and 562 received at least one dose of study drug (one participant was randomized in error but did not receive study drug).
Participant milestones
| Measure |
Placebo
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
109
|
227
|
226
|
|
Overall Study
COMPLETED
|
66
|
133
|
143
|
|
Overall Study
NOT COMPLETED
|
43
|
94
|
83
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
13
|
21
|
17
|
|
Overall Study
Lack of Efficacy
|
9
|
3
|
1
|
|
Overall Study
Protocol Violation
|
2
|
6
|
6
|
|
Overall Study
Protocol-defined Stopping Criteria
|
8
|
37
|
36
|
|
Overall Study
Study Closed/Terminated
|
2
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
7
|
5
|
|
Overall Study
Withdrawal by Subject
|
8
|
16
|
15
|
Baseline Characteristics
A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
Total
n=562 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.1 Years
STANDARD_DEVIATION 8.28 • n=5 Participants
|
61.7 Years
STANDARD_DEVIATION 9.10 • n=7 Participants
|
61.4 Years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 8.92 • n=4 Participants
|
|
Sex/Gender, Customized
African American/African Heritage (HER)
|
3 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Japanese/East Asian HER/South East Asian HER
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex/Gender, Customized
White
|
104 Participants
n=5 Participants
|
214 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
529 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
188 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
374 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From the start of study drug up to 52 weeksPopulation: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received at least one dose of randomized study drug
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the 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, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)
Any on-treatment AE
|
57 Participants
|
132 Participants
|
120 Participants
|
|
Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)
Any on-treatment SAE
|
7 Participants
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From the start of study drug up to 52 weeksPopulation: ITT Population
A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period
|
26 Participants
|
33 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: From the start of study drug up to 52 weeksPopulation: ITT Population
An on-treatment COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization at any time during the 52-week Treatment Period. The time to the first on-treatment exacerbation was calculated as the exacerbation onset date of the first on-treatment exacerbation minus the date of the start of treatment + 1. The median time to the first on-treatment exacerbation was derived from the Kaplan-Meier analysis. A participant who did not experience an exacerbation prior to completing the study or withdrawal is considered censored; a time to first COPD exacerbation cannot be calculated for these participants.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Time to the First On-treatment COPD Exacerbation
|
NA Days
Interval 1.0 to 372.0
Per Kaplan-Meier analysis, because 50% of the data were censored, the median could not be calculated.
|
NA Days
Interval 1.0 to 372.0
Per Kaplan-Meier analysis, because 50% of the data were censored, the median could not be calculated.
|
NA Days
Interval 1.0 to 372.0
Per Kaplan-Meier analysis, because 50% of the data were censored, the median could not be calculated.
|
SECONDARY outcome
Timeframe: Baseline; Months 3, 6, 9, and 12Population: ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.
Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
ALT, Month 3, n=88, 190, 193
|
0.3 International units per liter (IU/L)
Standard Deviation 12.53
|
0.8 International units per liter (IU/L)
Standard Deviation 9.40
|
0.6 International units per liter (IU/L)
Standard Deviation 15.27
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
ALT, Month 6, n=73, 158, 172
|
-1.3 International units per liter (IU/L)
Standard Deviation 14.03
|
3.2 International units per liter (IU/L)
Standard Deviation 22.35
|
1.0 International units per liter (IU/L)
Standard Deviation 16.83
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
ALT, Month 9, n=69, 148, 149
|
-0.6 International units per liter (IU/L)
Standard Deviation 12.81
|
-0.2 International units per liter (IU/L)
Standard Deviation 7.64
|
-0.5 International units per liter (IU/L)
Standard Deviation 14.68
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
ALT, Month 12, n=65, 129, 140
|
-1.7 International units per liter (IU/L)
Standard Deviation 14.92
|
1.3 International units per liter (IU/L)
Standard Deviation 15.63
|
-1.7 International units per liter (IU/L)
Standard Deviation 17.53
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
ALP, Month 3, n=88, 190, 193
|
1.1 International units per liter (IU/L)
Standard Deviation 21.90
|
-1.6 International units per liter (IU/L)
Standard Deviation 12.13
|
0.3 International units per liter (IU/L)
Standard Deviation 12.91
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
ALP, Month 6, n=73, 158, 172
|
-0.4 International units per liter (IU/L)
Standard Deviation 23.35
|
-1.6 International units per liter (IU/L)
Standard Deviation 17.15
|
-0.9 International units per liter (IU/L)
Standard Deviation 14.44
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
ALP, Month 9, n=69, 148, 149
|
-1.5 International units per liter (IU/L)
Standard Deviation 18.53
|
-2.2 International units per liter (IU/L)
Standard Deviation 12.68
|
0.0 International units per liter (IU/L)
Standard Deviation 16.51
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
ALP, Month 12, n=65, 129, 140
|
-1.9 International units per liter (IU/L)
Standard Deviation 18.09
|
4.3 International units per liter (IU/L)
Standard Deviation 61.45
|
0.2 International units per liter (IU/L)
Standard Deviation 15.93
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
AST, Month 3, n=88, 190, 192
|
0.1 International units per liter (IU/L)
Standard Deviation 19.27
|
1.3 International units per liter (IU/L)
Standard Deviation 10.87
|
1.0 International units per liter (IU/L)
Standard Deviation 14.75
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
AST, Month 6, n=73, 158, 172
|
-2.8 International units per liter (IU/L)
Standard Deviation 18.52
|
3.8 International units per liter (IU/L)
Standard Deviation 23.71
|
1.3 International units per liter (IU/L)
Standard Deviation 16.50
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
AST, Month 9, n=69, 148, 148
|
-1.1 International units per liter (IU/L)
Standard Deviation 10.79
|
0.1 International units per liter (IU/L)
Standard Deviation 6.53
|
-1.1 International units per liter (IU/L)
Standard Deviation 12.95
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
AST, Month 12, n=65, 129, 140
|
-0.6 International units per liter (IU/L)
Standard Deviation 12.06
|
2.6 International units per liter (IU/L)
Standard Deviation 15.71
|
-0.8 International units per liter (IU/L)
Standard Deviation 12.01
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
CK, Month 3, n=88, 190, 193
|
2.4 International units per liter (IU/L)
Standard Deviation 84.76
|
-1.8 International units per liter (IU/L)
Standard Deviation 97.44
|
7.0 International units per liter (IU/L)
Standard Deviation 63.51
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
CK, Month 6, n=73, 158, 172
|
-8.3 International units per liter (IU/L)
Standard Deviation 41.87
|
3.6 International units per liter (IU/L)
Standard Deviation 114.53
|
10.8 International units per liter (IU/L)
Standard Deviation 94.52
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
CK, Month 9, n=69, 148, 149
|
3.8 International units per liter (IU/L)
Standard Deviation 55.89
|
-2.3 International units per liter (IU/L)
Standard Deviation 113.58
|
3.5 International units per liter (IU/L)
Standard Deviation 58.82
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
CK, Month 12, n=64, 129, 140
|
-1.8 International units per liter (IU/L)
Standard Deviation 46.31
|
0.9 International units per liter (IU/L)
Standard Deviation 118.66
|
16.7 International units per liter (IU/L)
Standard Deviation 68.75
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
GGT, Month 3, n=88, 190, 193
|
11.5 International units per liter (IU/L)
Standard Deviation 95.98
|
1.0 International units per liter (IU/L)
Standard Deviation 24.07
|
-2.1 International units per liter (IU/L)
Standard Deviation 53.42
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
GGT, Month 6, n=73, 158, 172
|
-5.6 International units per liter (IU/L)
Standard Deviation 48.15
|
9.8 International units per liter (IU/L)
Standard Deviation 73.28
|
1.5 International units per liter (IU/L)
Standard Deviation 27.49
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
GGT, Month 9, n=69, 148, 149
|
-1.3 International units per liter (IU/L)
Standard Deviation 25.59
|
-0.5 International units per liter (IU/L)
Standard Deviation 22.45
|
-2.5 International units per liter (IU/L)
Standard Deviation 39.81
|
|
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
GGT, Month 12, n=65, 129, 140
|
-6.9 International units per liter (IU/L)
Standard Deviation 44.77
|
7.8 International units per liter (IU/L)
Standard Deviation 72.04
|
-2.0 International units per liter (IU/L)
Standard Deviation 30.93
|
SECONDARY outcome
Timeframe: Baseline; Months 3, 6, 9, and 12Population: ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.
Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Albumin, Month 3, n=88, 190, 193
|
-0.5 Grams per liter (G/L)
Standard Deviation 2.44
|
-0.8 Grams per liter (G/L)
Standard Deviation 2.48
|
-0.8 Grams per liter (G/L)
Standard Deviation 2.67
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Albumin, Month 6, n=73, 158, 172
|
-0.6 Grams per liter (G/L)
Standard Deviation 2.89
|
-0.9 Grams per liter (G/L)
Standard Deviation 2.59
|
-0.4 Grams per liter (G/L)
Standard Deviation 2.85
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Albumin, Month 9, n=69, 149, 149
|
-0.1 Grams per liter (G/L)
Standard Deviation 3.19
|
-0.8 Grams per liter (G/L)
Standard Deviation 2.55
|
-0.5 Grams per liter (G/L)
Standard Deviation 3.31
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Albumin, Month 12, n=65, 129, 140
|
-1.2 Grams per liter (G/L)
Standard Deviation 3.27
|
-1.4 Grams per liter (G/L)
Standard Deviation 2.35
|
-0.9 Grams per liter (G/L)
Standard Deviation 3.00
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Total protein, Month 3, n=88, 190, 193
|
-1.2 Grams per liter (G/L)
Standard Deviation 3.99
|
-1.3 Grams per liter (G/L)
Standard Deviation 3.52
|
-1.1 Grams per liter (G/L)
Standard Deviation 3.91
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Total protein, Month 6, n=73, 158, 172
|
-1.1 Grams per liter (G/L)
Standard Deviation 4.01
|
-1.8 Grams per liter (G/L)
Standard Deviation 3.57
|
-0.7 Grams per liter (G/L)
Standard Deviation 4.10
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Total protein, Month 9, n=69, 148, 149
|
-0.7 Grams per liter (G/L)
Standard Deviation 4.50
|
-1.8 Grams per liter (G/L)
Standard Deviation 3.52
|
-1.4 Grams per liter (G/L)
Standard Deviation 4.56
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Total protein, Month 12, n=65, 129, 140
|
-2.1 Grams per liter (G/L)
Standard Deviation 4.48
|
-2.6 Grams per liter (G/L)
Standard Deviation 3.48
|
-1.9 Grams per liter (G/L)
Standard Deviation 3.82
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Hemoglobin, Month 3, n=94, 198, 206
|
-1.2 Grams per liter (G/L)
Standard Deviation 8.51
|
-1.5 Grams per liter (G/L)
Standard Deviation 8.05
|
-2.0 Grams per liter (G/L)
Standard Deviation 8.34
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Hemoglobin, Month 6, n=75, 159, 171
|
-1.6 Grams per liter (G/L)
Standard Deviation 9.85
|
-1.2 Grams per liter (G/L)
Standard Deviation 7.31
|
-1.4 Grams per liter (G/L)
Standard Deviation 9.31
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Hemoglobin, Month 9, n=70, 152, 155
|
-1.4 Grams per liter (G/L)
Standard Deviation 11.95
|
-2.5 Grams per liter (G/L)
Standard Deviation 10.35
|
-2.2 Grams per liter (G/L)
Standard Deviation 8.78
|
|
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Hemoglobin, Month 12, n=63, 130, 143
|
-2.7 Grams per liter (G/L)
Standard Deviation 11.36
|
-2.5 Grams per liter (G/L)
Standard Deviation 7.04
|
-2.1 Grams per liter (G/L)
Standard Deviation 9.19
|
SECONDARY outcome
Timeframe: Baseline; Months 3, 6, 9, and 12Population: ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.
Blood samples were collected for the measurement of calcium, CO2 content/bicarbonate, chloride, glucose, IP, potassium, sodium, and urea/BUN at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
IP, Month 3, n=87, 189, 193
|
0.022 Millimoles per liter (mmol/L)
Standard Deviation 0.1844
|
0.003 Millimoles per liter (mmol/L)
Standard Deviation 0.1663
|
-0.018 Millimoles per liter (mmol/L)
Standard Deviation 0.1886
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
IP, Month 6, n=72, 157, 171
|
0.016 Millimoles per liter (mmol/L)
Standard Deviation 0.1880
|
0.015 Millimoles per liter (mmol/L)
Standard Deviation 0.1686
|
0.027 Millimoles per liter (mmol/L)
Standard Deviation 0.2125
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
IP, Month 9, n=68, 147, 149
|
-0.026 Millimoles per liter (mmol/L)
Standard Deviation 0.1773
|
-0.002 Millimoles per liter (mmol/L)
Standard Deviation 0.1850
|
0.005 Millimoles per liter (mmol/L)
Standard Deviation 0.1962
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
IP, Month 12, n=64, 129, 140
|
-0.007 Millimoles per liter (mmol/L)
Standard Deviation 0.1838
|
0.022 Millimoles per liter (mmol/L)
Standard Deviation 0.1821
|
0.011 Millimoles per liter (mmol/L)
Standard Deviation 0.1793
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Potassium, Month 3, n=88, 190, 192
|
0.04 Millimoles per liter (mmol/L)
Standard Deviation 0.464
|
0.05 Millimoles per liter (mmol/L)
Standard Deviation 0.490
|
0.08 Millimoles per liter (mmol/L)
Standard Deviation 0.474
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Potassium, Month 6, n=73, 158, 171
|
-0.05 Millimoles per liter (mmol/L)
Standard Deviation 0.462
|
0.02 Millimoles per liter (mmol/L)
Standard Deviation 0.468
|
0.00 Millimoles per liter (mmol/L)
Standard Deviation 0.428
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Potassium, Month 9, n=69, 149, 148
|
-0.14 Millimoles per liter (mmol/L)
Standard Deviation 0.461
|
-0.01 Millimoles per liter (mmol/L)
Standard Deviation 0.494
|
-0.05 Millimoles per liter (mmol/L)
Standard Deviation 0.498
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Potassium, Month 12, n=65, 129, 140
|
-0.06 Millimoles per liter (mmol/L)
Standard Deviation 0.489
|
-0.01 Millimoles per liter (mmol/L)
Standard Deviation 0.473
|
-0.04 Millimoles per liter (mmol/L)
Standard Deviation 0.510
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Sodium, Month 3, n=88, 190, 193
|
-0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.84
|
-0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.50
|
-0.8 Millimoles per liter (mmol/L)
Standard Deviation 2.36
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Sodium, Month 6, n=73, 158, 172
|
-0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.31
|
-0.8 Millimoles per liter (mmol/L)
Standard Deviation 2.63
|
-0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.48
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Sodium, Month 9, n=69, 149, 149
|
-0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.54
|
-0.8 Millimoles per liter (mmol/L)
Standard Deviation 2.72
|
-1.0 Millimoles per liter (mmol/L)
Standard Deviation 2.59
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Sodium, Month 12, n=64, 129, 140
|
-1.0 Millimoles per liter (mmol/L)
Standard Deviation 2.11
|
-0.7 Millimoles per liter (mmol/L)
Standard Deviation 2.40
|
-0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.75
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Urea/BUN, Month 3, n=88, 190, 193
|
-0.03 Millimoles per liter (mmol/L)
Standard Deviation 1.961
|
-0.18 Millimoles per liter (mmol/L)
Standard Deviation 1.574
|
-0.01 Millimoles per liter (mmol/L)
Standard Deviation 1.814
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Urea/BUN, Month 6, n=73, 158, 172
|
-0.06 Millimoles per liter (mmol/L)
Standard Deviation 2.734
|
-0.12 Millimoles per liter (mmol/L)
Standard Deviation 1.698
|
0.00 Millimoles per liter (mmol/L)
Standard Deviation 1.875
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Urea/BUN, Month 9, n=69, 149, 149
|
-0.12 Millimoles per liter (mmol/L)
Standard Deviation 1.981
|
-0.21 Millimoles per liter (mmol/L)
Standard Deviation 1.692
|
-0.11 Millimoles per liter (mmol/L)
Standard Deviation 1.696
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Urea/BUN, Month 12, n=65, 129, 140
|
0.13 Millimoles per liter (mmol/L)
Standard Deviation 2.591
|
-0.29 Millimoles per liter (mmol/L)
Standard Deviation 1.631
|
0.16 Millimoles per liter (mmol/L)
Standard Deviation 1.613
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Calcium, Month 3, n=88, 189, 192
|
-0.004 Millimoles per liter (mmol/L)
Standard Deviation 0.0957
|
-0.006 Millimoles per liter (mmol/L)
Standard Deviation 0.1178
|
-0.016 Millimoles per liter (mmol/L)
Standard Deviation 0.0990
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Calcium, Month 6, n=73, 157, 172
|
-0.027 Millimoles per liter (mmol/L)
Standard Deviation 0.0893
|
-0.011 Millimoles per liter (mmol/L)
Standard Deviation 0.1058
|
0.000 Millimoles per liter (mmol/L)
Standard Deviation 0.1104
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Calcium, Month 9, n=69, 147, 148
|
-0.027 Millimoles per liter (mmol/L)
Standard Deviation 0.1009
|
-0.019 Millimoles per liter (mmol/L)
Standard Deviation 0.1036
|
-0.014 Millimoles per liter (mmol/L)
Standard Deviation 0.1023
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Calcium, Month 12, n=65, 129, 140
|
-0.023 Millimoles per liter (mmol/L)
Standard Deviation 0.1070
|
-0.007 Millimoles per liter (mmol/L)
Standard Deviation 0.0959
|
-0.009 Millimoles per liter (mmol/L)
Standard Deviation 0.1059
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
CO2 content/bicarbonate, Month 3, n=88, 190, 192
|
0.8 Millimoles per liter (mmol/L)
Standard Deviation 2.99
|
0.8 Millimoles per liter (mmol/L)
Standard Deviation 2.70
|
0.6 Millimoles per liter (mmol/L)
Standard Deviation 2.87
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
CO2 content/bicarbonate, Month 6, n=73, 158, 172
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 3.03
|
0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.84
|
0.7 Millimoles per liter (mmol/L)
Standard Deviation 3.14
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
CO2 content/bicarbonate, Month 9, n=69, 149, 148
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 3.21
|
0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.78
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.87
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
CO2 content/bicarbonate, Month 12, n=65, 129, 140
|
-0.6 Millimoles per liter (mmol/L)
Standard Deviation 3.06
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.70
|
-0.4 Millimoles per liter (mmol/L)
Standard Deviation 2.49
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Chloride, Month 3, n=88, 190, 193
|
0.0 Millimoles per liter (mmol/L)
Standard Deviation 3.03
|
-0.2 Millimoles per liter (mmol/L)
Standard Deviation 3.33
|
-0.1 Millimoles per liter (mmol/L)
Standard Deviation 2.60
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Chloride, Month 6, n=73, 158, 172
|
-0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.84
|
-0.2 Millimoles per liter (mmol/L)
Standard Deviation 2.90
|
-0.1 Millimoles per liter (mmol/L)
Standard Deviation 3.23
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Chloride, Month 9, n=69, 149, 149
|
-0.7 Millimoles per liter (mmol/L)
Standard Deviation 3.27
|
-0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.93
|
-0.5 Millimoles per liter (mmol/L)
Standard Deviation 2.94
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Chloride, Month 12, n=64, 129, 140
|
-0.2 Millimoles per liter (mmol/L)
Standard Deviation 3.08
|
0.0 Millimoles per liter (mmol/L)
Standard Deviation 2.56
|
0.3 Millimoles per liter (mmol/L)
Standard Deviation 2.86
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Glucose, Month 3, n=88, 190, 193
|
0.08 Millimoles per liter (mmol/L)
Standard Deviation 1.269
|
0.08 Millimoles per liter (mmol/L)
Standard Deviation 1.315
|
0.03 Millimoles per liter (mmol/L)
Standard Deviation 1.419
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Glucose, Month 6, n=73, 158, 172
|
0.22 Millimoles per liter (mmol/L)
Standard Deviation 1.412
|
0.18 Millimoles per liter (mmol/L)
Standard Deviation 1.645
|
-0.01 Millimoles per liter (mmol/L)
Standard Deviation 2.507
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Glucose, Month 9, n=69, 149, 149
|
0.18 Millimoles per liter (mmol/L)
Standard Deviation 1.333
|
0.16 Millimoles per liter (mmol/L)
Standard Deviation 1.959
|
0.05 Millimoles per liter (mmol/L)
Standard Deviation 2.309
|
|
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Glucose, Month 12, n=65, 129, 140
|
0.19 Millimoles per liter (mmol/L)
Standard Deviation 1.080
|
0.00 Millimoles per liter (mmol/L)
Standard Deviation 1.741
|
0.01 Millimoles per liter (mmol/L)
Standard Deviation 2.453
|
SECONDARY outcome
Timeframe: Baseline; Months 3, 6, 9, and 12Population: ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.
Blood samples were collected for the measurement of creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Creatinine, Month 3, n=88, 190, 193
|
-3.20 Micromoles per liter (µmol/L)
Standard Deviation 16.221
|
-1.63 Micromoles per liter (µmol/L)
Standard Deviation 9.119
|
-0.51 Micromoles per liter (µmol/L)
Standard Deviation 10.034
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Creatinine, Month 6, n=73, 158, 171
|
-0.52 Micromoles per liter (µmol/L)
Standard Deviation 19.828
|
-1.14 Micromoles per liter (µmol/L)
Standard Deviation 9.047
|
0.13 Micromoles per liter (µmol/L)
Standard Deviation 11.418
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Creatinine, Month 9, n=69, 148, 149
|
-1.17 Micromoles per liter (µmol/L)
Standard Deviation 20.543
|
-0.71 Micromoles per liter (µmol/L)
Standard Deviation 9.780
|
0.26 Micromoles per liter (µmol/L)
Standard Deviation 11.057
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Creatinine, Month 12, n=65, 129, 140
|
-0.06 Micromoles per liter (µmol/L)
Standard Deviation 20.259
|
1.11 Micromoles per liter (µmol/L)
Standard Deviation 12.375
|
1.79 Micromoles per liter (µmol/L)
Standard Deviation 11.571
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Direct bilirubin, Month 3, n=88, 190, 192
|
0.0 Micromoles per liter (µmol/L)
Standard Deviation 1.08
|
0.1 Micromoles per liter (µmol/L)
Standard Deviation 1.13
|
0.0 Micromoles per liter (µmol/L)
Standard Deviation 1.05
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Direct Bilirubin, Month 6, n=73, 158, 172
|
-0.1 Micromoles per liter (µmol/L)
Standard Deviation 1.02
|
0.0 Micromoles per liter (µmol/L)
Standard Deviation 1.20
|
0.0 Micromoles per liter (µmol/L)
Standard Deviation 0.91
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Direct bilirubin, Month 9, n=69, 149, 149
|
0.0 Micromoles per liter (µmol/L)
Standard Deviation 1.06
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 0.98
|
-0.1 Micromoles per liter (µmol/L)
Standard Deviation 0.93
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Direct bilirubin, Month 12, n=65, 129, 139
|
0.1 Micromoles per liter (µmol/L)
Standard Deviation 0.88
|
0.8 Micromoles per liter (µmol/L)
Standard Deviation 8.77
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 1.12
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Indirect bilirubin, Month 3, n=88, 190, 192
|
0.1 Micromoles per liter (µmol/L)
Standard Deviation 3.30
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 3.64
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 3.03
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Indirect bilirubin, Month 6, n=73, 158, 172
|
-0.1 Micromoles per liter (µmol/L)
Standard Deviation 3.21
|
-0.3 Micromoles per liter (µmol/L)
Standard Deviation 3.69
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 2.94
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Indirect bilirubin, Month 9, n=69, 148, 149
|
0.2 Micromoles per liter (µmol/L)
Standard Deviation 3.68
|
-0.6 Micromoles per liter (µmol/L)
Standard Deviation 3.28
|
-0.3 Micromoles per liter (µmol/L)
Standard Deviation 2.93
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Indirect bilirubin, Month 12, n=65, 129, 139
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 2.74
|
0.4 Micromoles per liter (µmol/L)
Standard Deviation 8.60
|
-0.5 Micromoles per liter (µmol/L)
Standard Deviation 3.51
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Total bilirubin, Month 3, n=88, 190, 193
|
0.1 Micromoles per liter (µmol/L)
Standard Deviation 3.76
|
0.0 Micromoles per liter (µmol/L)
Standard Deviation 4.29
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 3.52
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Total bilirubin, Month 6, n=73, 158, 172
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 3.61
|
-0.3 Micromoles per liter (µmol/L)
Standard Deviation 4.37
|
-0.2 Micromoles per liter (µmol/L)
Standard Deviation 3.51
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Total bilirubin, Month 9, n=69, 148, 149
|
0.2 Micromoles per liter (µmol/L)
Standard Deviation 4.13
|
-0.8 Micromoles per liter (µmol/L)
Standard Deviation 3.82
|
-0.4 Micromoles per liter (µmol/L)
Standard Deviation 3.41
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Total bilirubin, Month 12, n=65, 129, 140
|
-0.1 Micromoles per liter (µmol/L)
Standard Deviation 3.06
|
1.2 Micromoles per liter (µmol/L)
Standard Deviation 17.09
|
-0.7 Micromoles per liter (µmol/L)
Standard Deviation 4.25
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Uric acid, Month 3, n=88, 189, 193
|
-3.4 Micromoles per liter (µmol/L)
Standard Deviation 68.15
|
-0.1 Micromoles per liter (µmol/L)
Standard Deviation 53.93
|
16.2 Micromoles per liter (µmol/L)
Standard Deviation 72.11
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Uric acid, Month 6, n=73, 157, 172
|
2.5 Micromoles per liter (µmol/L)
Standard Deviation 85.86
|
0.3 Micromoles per liter (µmol/L)
Standard Deviation 57.74
|
1.9 Micromoles per liter (µmol/L)
Standard Deviation 63.17
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Uric acid, Month 9, n=69, 147, 149
|
-2.9 Micromoles per liter (µmol/L)
Standard Deviation 72.40
|
-8.3 Micromoles per liter (µmol/L)
Standard Deviation 61.57
|
-1.9 Micromoles per liter (µmol/L)
Standard Deviation 66.69
|
|
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Uric acid, Month 12, n=65, 129, 140
|
11.4 Micromoles per liter (µmol/L)
Standard Deviation 80.09
|
-2.8 Micromoles per liter (µmol/L)
Standard Deviation 65.58
|
0.9 Micromoles per liter (µmol/L)
Standard Deviation 69.74
|
SECONDARY outcome
Timeframe: Baseline; Months 3, 6, 9, and 12Population: ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.
Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Basophils, Month 3, n=93, 198, 206
|
-0.02 Percentage in blood
Standard Deviation 0.244
|
0.01 Percentage in blood
Standard Deviation 0.290
|
0.02 Percentage in blood
Standard Deviation 0.302
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Basophils, Month 6, n=73, 156, 167
|
-0.03 Percentage in blood
Standard Deviation 0.270
|
0.03 Percentage in blood
Standard Deviation 0.312
|
0.01 Percentage in blood
Standard Deviation 0.314
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Basophils, Month 9, n=70, 152, 154
|
-0.01 Percentage in blood
Standard Deviation 0.265
|
0.02 Percentage in blood
Standard Deviation 0.276
|
0.02 Percentage in blood
Standard Deviation 0.300
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Basophils, Month 12, n=62, 130, 141
|
-0.05 Percentage in blood
Standard Deviation 0.235
|
0.00 Percentage in blood
Standard Deviation 0.240
|
0.02 Percentage in blood
Standard Deviation 0.266
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Eosinophils, Month 3, n=93, 198, 206
|
0.17 Percentage in blood
Standard Deviation 1.569
|
-0.01 Percentage in blood
Standard Deviation 2.243
|
-0.05 Percentage in blood
Standard Deviation 1.791
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Eosinophils, Month 6, n=73, 156, 167
|
0.04 Percentage in blood
Standard Deviation 1.720
|
-0.08 Percentage in blood
Standard Deviation 2.101
|
0.27 Percentage in blood
Standard Deviation 1.962
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Eosinophils, Month 9, n=70, 152, 154
|
0.18 Percentage in blood
Standard Deviation 2.271
|
-0.33 Percentage in blood
Standard Deviation 2.232
|
0.02 Percentage in blood
Standard Deviation 1.678
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Eosinophils, Month 12, n=62, 130, 141
|
0.10 Percentage in blood
Standard Deviation 1.698
|
-0.19 Percentage in blood
Standard Deviation 2.557
|
0.09 Percentage in blood
Standard Deviation 2.021
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Lymphocytes, Month 3, n=93, 198, 206
|
-1.02 Percentage in blood
Standard Deviation 8.031
|
-1.86 Percentage in blood
Standard Deviation 7.912
|
-0.92 Percentage in blood
Standard Deviation 7.474
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Lymphocytes, Month 6, n=73, 156, 167
|
-1.14 Percentage in blood
Standard Deviation 7.178
|
-0.33 Percentage in blood
Standard Deviation 10.319
|
0.81 Percentage in blood
Standard Deviation 9.211
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Lymphocytes, Month 9, n=70, 152, 154
|
-2.63 Percentage in blood
Standard Deviation 6.977
|
-1.32 Percentage in blood
Standard Deviation 8.439
|
-1.35 Percentage in blood
Standard Deviation 8.265
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Lymphocytes, Month 12, n=62, 130, 141
|
-0.93 Percentage in blood
Standard Deviation 6.654
|
-0.55 Percentage in blood
Standard Deviation 7.459
|
-0.25 Percentage in blood
Standard Deviation 7.138
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Monocytes, Month 3, n=93, 198, 206
|
-0.02 Percentage in blood
Standard Deviation 2.544
|
-0.06 Percentage in blood
Standard Deviation 2.303
|
0.13 Percentage in blood
Standard Deviation 2.296
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Monocytes, Month 6, n=73, 156, 167
|
0.60 Percentage in blood
Standard Deviation 2.929
|
1.09 Percentage in blood
Standard Deviation 3.170
|
0.56 Percentage in blood
Standard Deviation 2.935
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Monocytes, Month 9, n=70, 152, 154
|
0.14 Percentage in blood
Standard Deviation 2.959
|
0.62 Percentage in blood
Standard Deviation 2.453
|
0.24 Percentage in blood
Standard Deviation 2.466
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Monocytes, Month 12, n=62, 130, 141
|
0.26 Percentage in blood
Standard Deviation 2.563
|
0.47 Percentage in blood
Standard Deviation 2.632
|
-0.16 Percentage in blood
Standard Deviation 2.198
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Segmented neutrophils, Month 3, n=93, 198, 206
|
0.88 Percentage in blood
Standard Deviation 9.494
|
1.92 Percentage in blood
Standard Deviation 9.714
|
0.81 Percentage in blood
Standard Deviation 9.002
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Segmented neutrophils, Month 6, n=73, 156, 167
|
0.53 Percentage in blood
Standard Deviation 9.264
|
-0.72 Percentage in blood
Standard Deviation 12.744
|
-1.65 Percentage in blood
Standard Deviation 11.543
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Segmented neutrophils, Month 9, n=70, 152, 154
|
2.02 Percentage in blood
Standard Deviation 8.225
|
1.00 Percentage in blood
Standard Deviation 10.311
|
1.07 Percentage in blood
Standard Deviation 9.472
|
|
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Segmented neutrophils, Month 12, n=62, 130, 141
|
0.63 Percentage in blood
Standard Deviation 7.903
|
0.27 Percentage in blood
Standard Deviation 10.026
|
0.29 Percentage in blood
Standard Deviation 8.456
|
SECONDARY outcome
Timeframe: Baseline; Months 3, 6, 9, and 12Population: ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized for different parameters/at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.
Blood samples were collected for the measurement of eosinophils, platelets, and WBC count at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Eosinophil count, Month 3, n=93, 198, 206
|
0.001 10^9 cells per liter (GI/L)
Standard Deviation 0.1134
|
-0.002 10^9 cells per liter (GI/L)
Standard Deviation 0.1497
|
-0.007 10^9 cells per liter (GI/L)
Standard Deviation 0.1292
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Eosinophil count, Month 6, n=73, 156, 167
|
-0.005 10^9 cells per liter (GI/L)
Standard Deviation 0.1246
|
-0.007 10^9 cells per liter (GI/L)
Standard Deviation 0.1277
|
0.015 10^9 cells per liter (GI/L)
Standard Deviation 0.1324
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Eosinophil count, Month 9, n=70, 152, 154
|
0.003 10^9 cells per liter (GI/L)
Standard Deviation 0.1613
|
-0.023 10^9 cells per liter (GI/L)
Standard Deviation 0.1445
|
0.001 10^9 cells per liter (GI/L)
Standard Deviation 0.1227
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Eosinophil count, Month 12, n=62, 130, 141
|
-0.003 10^9 cells per liter (GI/L)
Standard Deviation 0.1297
|
-0.013 10^9 cells per liter (GI/L)
Standard Deviation 0.1678
|
0.010 10^9 cells per liter (GI/L)
Standard Deviation 0.1496
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Platelet count, Month 3, n=93, 197, 204
|
2.2 10^9 cells per liter (GI/L)
Standard Deviation 40.22
|
-4.4 10^9 cells per liter (GI/L)
Standard Deviation 38.28
|
4.4 10^9 cells per liter (GI/L)
Standard Deviation 34.39
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Platelet count, Month 6, n=73, 155, 169
|
-11.6 10^9 cells per liter (GI/L)
Standard Deviation 39.11
|
-5.4 10^9 cells per liter (GI/L)
Standard Deviation 39.61
|
-0.6 10^9 cells per liter (GI/L)
Standard Deviation 33.65
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Platelet count, Month 9, n=68, 151, 154
|
-9.5 10^9 cells per liter (GI/L)
Standard Deviation 39.36
|
-3.0 10^9 cells per liter (GI/L)
Standard Deviation 39.85
|
0.7 10^9 cells per liter (GI/L)
Standard Deviation 37.24
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Platelet count, Month 12, n=61, 128, 140
|
-11.8 10^9 cells per liter (GI/L)
Standard Deviation 34.45
|
-4.4 10^9 cells per liter (GI/L)
Standard Deviation 33.09
|
4.4 10^9 cells per liter (GI/L)
Standard Deviation 37.68
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
WBC count, Month 3, n=93, 198, 206
|
-0.20 10^9 cells per liter (GI/L)
Standard Deviation 1.575
|
-0.27 10^9 cells per liter (GI/L)
Standard Deviation 1.781
|
-0.21 10^9 cells per liter (GI/L)
Standard Deviation 1.797
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
WBC count, Month 6, n=73, 156, 167
|
-0.06 10^9 cells per liter (GI/L)
Standard Deviation 1.666
|
-0.13 10^9 cells per liter (GI/L)
Standard Deviation 1.663
|
-0.23 10^9 cells per liter (GI/L)
Standard Deviation 2.065
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
WBC count, Month 9, n=70, 152, 154
|
0.29 10^9 cells per liter (GI/L)
Standard Deviation 2.820
|
-0.09 10^9 cells per liter (GI/L)
Standard Deviation 1.919
|
-0.19 10^9 cells per liter (GI/L)
Standard Deviation 1.850
|
|
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
WBC count, Month 12, n=62, 130, 141
|
-0.19 10^9 cells per liter (GI/L)
Standard Deviation 1.600
|
-0.21 10^9 cells per liter (GI/L)
Standard Deviation 2.114
|
-0.09 10^9 cells per liter (GI/L)
Standard Deviation 1.871
|
SECONDARY outcome
Timeframe: Baseline; Months 3, 6, 9, and 12Population: ITT Population. Only those participants available at the specified time points were summarized (represented by n=X, X, X in the category titles). Different participants may have been summarized at different time points, so the overall number of participants summarized reflects everyone in the ITT Population.
Blood samples were collected for the measurement of hematocrit at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hematocrit at Months 3, 6, 9, and 12
Month 3, n=94, 198, 206
|
-0.0140 Proportion of red blood cells in blood
Standard Deviation 0.02757
|
-0.0134 Proportion of red blood cells in blood
Standard Deviation 0.02656
|
-0.0131 Proportion of red blood cells in blood
Standard Deviation 0.02699
|
|
Change From Baseline in Hematocrit at Months 3, 6, 9, and 12
Month 6, n=75, 159, 171
|
-0.0195 Proportion of red blood cells in blood
Standard Deviation 0.03320
|
-0.0177 Proportion of red blood cells in blood
Standard Deviation 0.02446
|
-0.0170 Proportion of red blood cells in blood
Standard Deviation 0.02871
|
|
Change From Baseline in Hematocrit at Months 3, 6, 9, and 12
Month 9, n=70, 152, 155
|
-0.0133 Proportion of red blood cells in blood
Standard Deviation 0.03785
|
-0.0139 Proportion of red blood cells in blood
Standard Deviation 0.03158
|
-0.0146 Proportion of red blood cells in blood
Standard Deviation 0.02829
|
|
Change From Baseline in Hematocrit at Months 3, 6, 9, and 12
Month 12, n=63, 130, 143
|
-0.0072 Proportion of red blood cells in blood
Standard Deviation 0.03336
|
-0.0045 Proportion of red blood cells in blood
Standard Deviation 0.02356
|
-0.0040 Proportion of red blood cells in blood
Standard Deviation 0.2959
|
SECONDARY outcome
Timeframe: Baseline; from the start of study drug up to 52 weeksPopulation: ITT Population
Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for SBP and the minimum post-Basline value for DBP were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period
Change from Baseline to maximum SBP
|
14.5 Millimeters of mercury (mmHg)
Standard Deviation 15.28
|
14.0 Millimeters of mercury (mmHg)
Standard Deviation 14.05
|
13.5 Millimeters of mercury (mmHg)
Standard Deviation 13.02
|
|
Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period
Change from Baseline to minimum DBP
|
-11.0 Millimeters of mercury (mmHg)
Standard Deviation 8.87
|
-9.5 Millimeters of mercury (mmHg)
Standard Deviation 7.86
|
-10.8 Millimeters of mercury (mmHg)
Standard Deviation 8.89
|
SECONDARY outcome
Timeframe: Baseline; from the start of study drug up to 52 weeksPopulation: ITT Population
Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for pulse rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period
|
9.1 Beats per minute
Standard Deviation 9.30
|
9.8 Beats per minute
Standard Deviation 10.16
|
9.0 Beats per minute
Standard Deviation 9.04
|
SECONDARY outcome
Timeframe: Baseline; from the start of study drug up to 52 weeksPopulation: ITT Population
12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline values for QTcF, QTcB, and PR interval were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF), and PR Interval Over the Course of the 52-week
Maximum change from Baseline in QTcF
|
15.6 Milliseconds
Standard Deviation 13.67
|
16.9 Milliseconds
Standard Deviation 14.20
|
18.4 Milliseconds
Standard Deviation 14.42
|
|
Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF), and PR Interval Over the Course of the 52-week
Maximum change from Baseline in QTcB
|
17.1 Milliseconds
Standard Deviation 16.90
|
19.0 Milliseconds
Standard Deviation 17.62
|
20.7 Milliseconds
Standard Deviation 17.14
|
|
Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF), and PR Interval Over the Course of the 52-week
Maximum change from Baseline in PR interval
|
12.4 Milliseconds
Standard Deviation 11.03
|
13.5 Milliseconds
Standard Deviation 10.26
|
12.0 Milliseconds
Standard Deviation 9.79
|
SECONDARY outcome
Timeframe: Baseline; from the start of study drug up to 52 weeksPopulation: ITT Population
12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for heart rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period
|
7.8 Beats per minute
Standard Deviation 8.67
|
9.9 Beats per minute
Standard Deviation 13.66
|
9.3 Beats per minute
Standard Deviation 9.43
|
SECONDARY outcome
Timeframe: From the start of study drug up to 52 weeksPopulation: ITT Population
Post-Baseline visits include scheduled, unscheduled, and Early Withdrawal visits. Only the worst-case interpretation was counted for each participant. Clinical significance and abnormal/normal findings are based on the assessment of the independent cardiologists.
Outcome measures
| Measure |
Placebo
n=109 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=227 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline
Normal
|
32 participants
|
64 participants
|
71 participants
|
|
Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline
Abnormal - Not Clinically Significant
|
52 participants
|
105 participants
|
101 participants
|
|
Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline
Abnormal - Clinically Significant
|
25 participants
|
58 participants
|
54 participants
|
|
Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline
Unable to Evaluate
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Screening; from the start of study drug up to 52 weeksPopulation: ITT Population. Only those participants providing at least one post-Baseline interpretation were summarized.
Twenty-four hour Holter monitor (12-lead) evaluations were obtained. Holter Baseline values were those recorded at Screening. An "any time post-Baseline" Holter evaluation was derived as the worst evaluation recorded at any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Screening was calculated as the post-Screening value minus the Screening value. The order of severity for change from Screening Holter evaluation from worst to best is: clinically significant change: unfavorable; no change or insignificant change; clinically significant change: favorable, unable to compare, based on the assessment of the independent cardiologists.
Outcome measures
| Measure |
Placebo
n=90 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=198 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=207 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation
Clinically significant change: unfavorable
|
39 Participants
|
86 Participants
|
87 Participants
|
|
Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation
No change or insignificant change
|
46 Participants
|
98 Participants
|
110 Participants
|
|
Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation
Clinically significant change: favorable
|
3 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation
Unable to compare
|
2 Participants
|
8 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline; from the start of study drug up to 52 weeksPopulation: ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the analysis.
Participants recorded the number of puffs and/or the number of nebules of rescue albuterol/salbutamol and/or ipratropium bromide used in the past 24 hours for the relief of COPD symptoms in the daily diary. The total puffs of rescue medication for each day was calculated as follows: (number of salbutamol puffs + number of ipratropium puffs + \[2 \* number of salbutamol nebules\] + \[2 \* number of ipratropium nebules\]). Baseline is the mean during the week prior to Day 1. Change from Baseline was calculated as the mean number of puffs/day over Weeks 1-52 minus the mean number of puffs/day at Baseline. Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the week prior to Day 1), smoking status, and center group.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=158 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=168 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period
|
-0.4 Number of puffs per day
Standard Error 0.20
|
-0.8 Number of puffs per day
Standard Error 0.14
|
-1.4 Number of puffs per day
Standard Error 0.13
|
SECONDARY outcome
Timeframe: From the start of study drug up to 52 weeksPopulation: ITT Population. Only those participants who had rescue data available on at least 50% of the days in the 52-week treatment period were included in the summary.
Rescue-free days are defined as days on which albuterol/salbutamol and/or ipratropium bromide was not used. Baseline is the percentage during the week prior to Day 1. Change from Baseline was calculated as the mean percentage of rescue-free days over Weeks 1-52 minus the mean percentage of rescue-free days at Baseline.
Outcome measures
| Measure |
Placebo
n=75 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=158 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=168 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period
|
11.1 Percentage of rescue-free days
Standard Deviation 30.06
|
13.1 Percentage of rescue-free days
Standard Deviation 37.35
|
23.2 Percentage of rescue-free days
Standard Deviation 39.27
|
SECONDARY outcome
Timeframe: Baseline; Months 1, 3, 6, 9, and 12Population: ITT Population. The overall number of participants reflects all participants who provided at least one post-treatment assessment. Participants who provided data the specified time points are represented by n=X, X, X in the category titles.
FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FEV1 and FVC were the values obtained approximately 24 hours after the previous morning's dose of study medication. Baseline is the value recorded pre-dose on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (assessment made immediately pre-dose on Day 1), smoking status, center group, month, and month by Baseline and month by treatment interactions.
Outcome measures
| Measure |
Placebo
n=103 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
|
UMEC 125 µg
n=215 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=216 Participants
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FEV1: Month 1, n=103, 215, 215
|
-0.030 Liters
Standard Error 0.0253
|
0.138 Liters
Standard Error 0.0175
|
0.161 Liters
Standard Error 0.0174
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FEV1: Month 3, n=90, 197, 208
|
-0.036 Liters
Standard Error 0.0289
|
0.140 Liters
Standard Error 0.0197
|
0.189 Liters
Standard Error 0.0192
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FEV1: Month 6, n=79, 163, 178
|
-0.015 Liters
Standard Error 0.0320
|
0.144 Liters
Standard Error 0.0221
|
0.181 Liters
Standard Error 0.0214
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FEV1: Month 9, n=71, 142, 153
|
-0.050 Liters
Standard Error 0.0314
|
0.104 Liters
Standard Error 0.0219
|
0.180 Liters
Standard Error 0.0213
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FEV1: Month 12, n=66, 132, 143
|
-0.045 Liters
Standard Error 0.0332
|
0.133 Liters
Standard Error 0.0232
|
0.186 Liters
Standard Error 0.0224
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FVC: Month 1, n=103, 215, 215
|
-0.035 Liters
Standard Error 0.0386
|
0.197 Liters
Standard Error 0.0267
|
0.237 Liters
Standard Error 0.0267
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FVC: Month 3, n=90, 197, 208
|
-0.044 Liters
Standard Error 0.0442
|
0.189 Liters
Standard Error 0.0301
|
0.244 Liters
Standard Error 0.0295
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FVC: Month 6, n=79, 163, 178
|
-0.002 Liters
Standard Error 0.0478
|
0.206 Liters
Standard Error 0.0330
|
0.237 Liters
Standard Error 0.0320
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FVC: Month 9, n=71, 142, 153
|
-0.076 Liters
Standard Error 0.0510
|
0.088 Liters
Standard Error 0.0356
|
0.200 Liters
Standard Error 0.0345
|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
FVC: Month 12, n=66, 132, 143
|
-0.039 Liters
Standard Error 0.0491
|
0.155 Liters
Standard Error 0.0343
|
0.213 Liters
Standard Error 0.0333
|
Adverse Events
Placebo
Serious events: 7 serious events
Other events: 34 other events
Deaths: 0 deaths
UMEC 125 µg
Serious events: 17 serious events
Other events: 78 other events
Deaths: 0 deaths
UMEC/VI 125/25 µg
Serious events: 14 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=109 participants at risk
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.ve
|
UMEC 125 µg
n=227 participants at risk
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 participants at risk
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Surgical and medical procedures
Skin graft
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.8%
3/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
1.8%
4/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.88%
2/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Coronary artery disease
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.88%
2/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Rhythm idioventricular
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
1.3%
3/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.88%
2/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Infections and infestations
Infection
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder neoplasm
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Nervous system disorders
Psychomotor hyperactivity
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
General disorders
Chest pain
|
0.92%
1/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Investigations
Clostridium test positive
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Psychiatric disorders
Depression
|
0.00%
0/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.00%
0/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.44%
1/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
Other adverse events
| Measure |
Placebo
n=109 participants at risk
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.ve
|
UMEC 125 µg
n=227 participants at risk
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
|
UMEC/VI 125/25 µg
n=226 participants at risk
Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
4.6%
5/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
8.8%
20/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
4.9%
11/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Infections and infestations
Sinusitis
|
2.8%
3/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
2.6%
6/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
3.5%
8/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Infections and infestations
Influenza
|
4.6%
5/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
2.2%
5/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
2.7%
6/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.8%
3/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
3.5%
8/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
0.88%
2/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Nervous system disorders
Headache
|
8.3%
9/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
11.0%
25/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
8.8%
20/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Ventricular extrasystoles
|
4.6%
5/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
4.8%
11/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
4.9%
11/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Extrasystoles
|
3.7%
4/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
4.4%
10/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
4.4%
10/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
3.7%
4/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
1.3%
3/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
1.8%
4/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
3/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
4.0%
9/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
4.4%
10/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
|
Vascular disorders
Hypertension
|
4.6%
5/109 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
1.3%
3/227 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug.
|
3.1%
7/226 • On-treatment serious adverse events (SAEs) and non-serious AEs were collected from on or after the date of the first dose of study drug to up to 1 day after the date of the last recorded dose of study drug (up to Study Week 52).
On-treatment AEs and SAEs were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized 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