Trial Outcomes & Findings for Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02570165)
NCT ID: NCT02570165
Last Updated: 2019-07-16
Results Overview
FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath. Weighted-mean change from Baseline was the weighted-mean FEV1 on Day 42 minus Baseline where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The 0-6 hour (Hr.) serial FEV1 was collected at Day 1 (Visit 2) and Day 42 (Visit 6). The weighted-mean was derived by calculating the area under the curve (AUC) of FEV1 over the 6 hour period, and then dividing it by the 6-hour time interval. Batefenterol dose for each individual was compared with placebo or UMEC/VI. The change from Baseline in FEV1 was statistically analyzed using Bayesian Emax modeling of the dose response curve. Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment and who received at least one dose of study medication. Participants with FEV1 values available at Baseline and Day 42 were analyzed.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
325 participants
Primary outcome timeframe
Baseline and Day 42
Results posted on
2019-07-16
Participant Flow
Eligible participants (par.) with an established clinical history of Chronic Obstructive Pulmonary Disease (COPD), were included in this dose-finding study of batefenterol (BAT). Of 585 par. screened, 324 par. were randomized in the study, out of which one par. was randomized in error and was not included in the Intent-to-Treat analysis.
Pre-bronchodilator and post albuterol/salbutamol spirometry testing were performed at Screening visit. Post-albuterol/salbutamol (Forced expiratory Volume in One Second) FEV1 and FEV1/ (Forced Vital Capacity) FVC values were used to determine subject eligibility. Participants underwent 2 weeks run-in period.
Participant milestones
| Measure |
Placebo
Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
|
Batefenterol 37.5 µg
Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 75 µg
Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 150 µg
Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 300 µg
Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 600 µg
Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
UMEC/VI 62.5/25 µg
Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
46
|
46
|
46
|
45
|
47
|
46
|
47
|
|
Overall Study
COMPLETED
|
44
|
43
|
41
|
40
|
41
|
44
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
5
|
5
|
6
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
|
Batefenterol 37.5 µg
Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 75 µg
Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 150 µg
Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 300 µg
Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 600 µg
Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
UMEC/VI 62.5/25 µg
Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
4
|
0
|
0
|
|
Overall Study
Par. Reached Stopping Criteria
|
1
|
1
|
0
|
2
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Par. did not Meet Continuation Criteria
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal Request by GSK
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo
n=46 Participants
Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
|
Batefenterol 37.5 µg
n=46 Participants
Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 75 µg
n=46 Participants
Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 150 µg
n=45 Participants
Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 300 µg
n=47 Participants
Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 600 µg
n=46 Participants
Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
UMEC/VI 62.5/25 µg
n=47 Participants
Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
61.1 Years
STANDARD_DEVIATION 6.60 • n=5 Participants
|
61.9 Years
STANDARD_DEVIATION 8.16 • n=7 Participants
|
63.0 Years
STANDARD_DEVIATION 7.21 • n=5 Participants
|
63.6 Years
STANDARD_DEVIATION 8.11 • n=4 Participants
|
61.9 Years
STANDARD_DEVIATION 8.70 • n=21 Participants
|
63.7 Years
STANDARD_DEVIATION 7.06 • n=10 Participants
|
62.8 Years
STANDARD_DEVIATION 8.46 • n=115 Participants
|
62.6 Years
STANDARD_DEVIATION 7.78 • n=6 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
25 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
143 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
21 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
180 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
23 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
38 Participants
n=10 Participants
|
39 Participants
n=115 Participants
|
265 Participants
n=6 Participants
|
|
Race/Ethnicity, Customized
Multiple Geographic Ancestries
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
35 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 42Population: ITT Population.
FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath. Weighted-mean change from Baseline was the weighted-mean FEV1 on Day 42 minus Baseline where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The 0-6 hour (Hr.) serial FEV1 was collected at Day 1 (Visit 2) and Day 42 (Visit 6). The weighted-mean was derived by calculating the area under the curve (AUC) of FEV1 over the 6 hour period, and then dividing it by the 6-hour time interval. Batefenterol dose for each individual was compared with placebo or UMEC/VI. The change from Baseline in FEV1 was statistically analyzed using Bayesian Emax modeling of the dose response curve. Intent-to-Treat (ITT) Population comprised of all participants randomized to treatment and who received at least one dose of study medication. Participants with FEV1 values available at Baseline and Day 42 were analyzed.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
|
Batefenterol 37.5 µg
n=42 Participants
Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 75 µg
n=41 Participants
Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 150 µg
n=39 Participants
Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 300 µg
n=41 Participants
Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 600 µg
n=44 Participants
Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
UMEC/VI 62.5/25 µg
n=47 Participants
Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Weighted Mean FEV1 Over 0 to 6 Hours Post-dose at Day 42
|
-9.90 Milliliters (mL)
Standard Error 31.21
|
181.20 Milliliters (mL)
Standard Error 30.85
|
221.68 Milliliters (mL)
Standard Error 21.09
|
251.87 Milliliters (mL)
Standard Error 16.30
|
271.47 Milliliters (mL)
Standard Error 19.49
|
282.94 Milliliters (mL)
Standard Error 24.20
|
275.43 Milliliters (mL)
Standard Error 29.91
|
SECONDARY outcome
Timeframe: Baseline and Day 42Population: ITT Population
Trough FEV1 at Day 42 is the mean volume of air that can be forced out in one second after taking a deep breath at the approximately 23 Hrs and 24 Hrs assessments after the last administration of study drug. Batefenterol dose for each individual was compared with placebo or UMEC/VI. Change from Baseline was calculated as trough FEV1 on Day 42 minus baseline, where Baseline is defined as the average of Day1 pre-dose FEV1 measured at -30 minutes and 0 minutes. The Maximum Likelihood Estimation (MLE) method of dose response modeling with Emax modeling without Bayesian priors was used. Participants with FEV1 values available at Baseline and Day 42 after 24 hrs after the last administration of study drug were analyzed.
Outcome measures
| Measure |
Placebo
n=44 Participants
Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
|
Batefenterol 37.5 µg
n=43 Participants
Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 75 µg
n=41 Participants
Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 150 µg
n=40 Participants
Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 300 µg
n=41 Participants
Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 600 µg
n=44 Participants
Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
UMEC/VI 62.5/25 µg
n=47 Participants
Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
|
|---|---|---|---|---|---|---|---|
|
Change From Baseline in Trough FEV1 at Day 42
|
-35.7 mL
Standard Error 30.80
|
146.5 mL
Standard Error 28.30
|
160.8 mL
Standard Error 15.60
|
168.9 mL
Standard Error 15.00
|
173.2 mL
Standard Error 18.20
|
175.4 mL
Standard Error 20.50
|
209.0 mL
Standard Error 29.80
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Batefenterol 37.5 µg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Batefenterol 75 µg
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Batefenterol 150 µg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Batefenterol 300 µg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Batefenterol 600 µg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
UMEC/VI 62.5/25 µg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=46 participants at risk
Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
|
Batefenterol 37.5 µg
n=46 participants at risk
Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 75 µg
n=46 participants at risk
Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained btefenterol blended with lactose.
|
Batefenterol 150 µg
n=45 participants at risk
Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 300 µg
n=47 participants at risk
Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 600 µg
n=46 participants at risk
Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
UMEC/VI 62.5/25 µg
n=47 participants at risk
Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.1%
1/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.1%
1/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
Other adverse events
| Measure |
Placebo
n=46 participants at risk
Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
|
Batefenterol 37.5 µg
n=46 participants at risk
Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 75 µg
n=46 participants at risk
Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained btefenterol blended with lactose.
|
Batefenterol 150 µg
n=45 participants at risk
Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 300 µg
n=47 participants at risk
Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
Batefenterol 600 µg
n=46 participants at risk
Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
|
UMEC/VI 62.5/25 µg
n=47 participants at risk
Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
4.3%
2/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Infections and infestations
Nasopharyngitis
|
4.3%
2/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
6.5%
3/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
6.5%
3/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
4.3%
2/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.1%
1/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
4.3%
2/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.1%
1/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
4.3%
2/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
4.4%
2/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.1%
1/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
13.0%
6/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
4.3%
2/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
4.4%
2/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
8.5%
4/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
10.9%
5/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.1%
1/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
|
Vascular disorders
Hypertension
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.2%
1/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
4.3%
2/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/45 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
2.1%
1/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/46 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
0.00%
0/47 • Serious Adverse Events (SAEs) were collected from start of study until follow-up contact (Visit7[Visit 6/EW+7days]). Non-serious AEs were collected from start of study treatment (Visit2) until follow-up contact (Visit7[Visit 6/EW+7days]).
AE and SAE analysis was based on ITT Population consisting of all participants randomized to treatment and who received at least one dose of study medication. On-treatment AEs and SAEs were defined as those with onset between treatment start date and treatment stop date +1.
|
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