Trial Outcomes & Findings for GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease (NCT NCT00950807)
NCT ID: NCT00950807
Last Updated: 2017-11-08
Results Overview
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
Baseline and Day 15 of each treatment period (up to Study Day 71)
Results posted on
2017-11-08
Participant Flow
Participants (par.) who were eligible completed a 4- to 7-day Run-in period prior to randomization. The treatment (trt) phase was comprised of three 14-day trt periods. Par. were randomly assigned to receive a sequence of placebo and 2 of the 9 active trts over the trt phase. Participant Flow data are presented by treatment rather than sequence.
Participant milestones
| Measure |
Placebo
Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
|
UMEC 62.5 µg QD
Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 125 µg QD
Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 250 µg QD
Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 500 µg QD
Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 1000 µg QD
Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 62.5 µg BID
Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 125 µg BID
Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 250 µg BID
Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
Tiotropium 18 µg QD
Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
59
|
13
|
14
|
12
|
13
|
13
|
12
|
14
|
13
|
13
|
|
Treatment Period 1
COMPLETED
|
56
|
13
|
13
|
12
|
12
|
11
|
12
|
14
|
12
|
13
|
|
Treatment Period 1
NOT COMPLETED
|
3
|
0
|
1
|
0
|
1
|
2
|
0
|
0
|
1
|
0
|
|
Washout Period 1
STARTED
|
56
|
13
|
13
|
12
|
12
|
11
|
12
|
14
|
12
|
13
|
|
Washout Period 1
COMPLETED
|
51
|
13
|
13
|
11
|
11
|
11
|
10
|
13
|
11
|
13
|
|
Washout Period 1
NOT COMPLETED
|
5
|
0
|
0
|
1
|
1
|
0
|
2
|
1
|
1
|
0
|
|
Treatment Period 2
STARTED
|
53
|
13
|
10
|
13
|
13
|
10
|
10
|
13
|
11
|
11
|
|
Treatment Period 2
COMPLETED
|
51
|
12
|
10
|
12
|
13
|
9
|
9
|
10
|
11
|
11
|
|
Treatment Period 2
NOT COMPLETED
|
2
|
1
|
0
|
1
|
0
|
1
|
1
|
3
|
0
|
0
|
|
Washout Period 2
STARTED
|
51
|
12
|
10
|
12
|
13
|
9
|
9
|
10
|
11
|
11
|
|
Washout Period 2
COMPLETED
|
47
|
11
|
10
|
11
|
12
|
9
|
8
|
9
|
11
|
11
|
|
Washout Period 2
NOT COMPLETED
|
4
|
1
|
0
|
1
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Treatment Period 3
STARTED
|
46
|
9
|
10
|
11
|
12
|
9
|
12
|
10
|
9
|
11
|
|
Treatment Period 3
COMPLETED
|
45
|
9
|
10
|
11
|
12
|
9
|
11
|
9
|
9
|
10
|
|
Treatment Period 3
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
|
UMEC 62.5 µg QD
Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 125 µg QD
Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 250 µg QD
Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 500 µg QD
Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 1000 µg QD
Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 62.5 µg BID
Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 125 µg BID
Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 250 µg BID
Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
Tiotropium 18 µg QD
Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Treatment Period 1
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 1
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Washout Period 1
Lack of Efficacy
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Washout Period 1
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Washout Period 1
Protocol-defined Stopping Criteria
|
3
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Washout Period 1
Adverse Event
|
2
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
2
|
0
|
0
|
|
Treatment Period 2
Protocol-defined Stopping Criteria
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 2
Adverse Event
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Washout Period 2
Lack of Efficacy
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout Period 2
Protocol-defined Stopping Criteria
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
1
|
0
|
0
|
|
Washout Period 2
Adverse Event
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Treatment Period 3
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Treatment Period 3
Protocol-defined Stopping Criteria
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Treatment Period 3
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
All Study Treatments
n=176 Participants
The treatment phase was comprised of three 14-day treatment periods, each separated by a 10-14 day washout period. Participants were randomly assigned to receive a sequence of placebo and 2 of the 9 active treatments :
UMEC 62.5, 125, 250, 500, and 1000 µg QD, UMEC 62.5, 125, and 250 µg BID, tiotropium 18 µg QD.
|
|---|---|
|
Age, Continuous
|
59.7 Years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
172 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 15 of each treatment period (up to Study Day 71)Population: Modified Intent-To-Treat (mITT) Population: all participants randomized to treatment who received at least one dose of study medication. All participants with \>=1 post-baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 15.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 on Treatment Day 15 is defined as the value obtained 24 hours after the morning dose administered on Day 14. Analysis were performed using a mixed model with covariates of mean Baseline, period Baseline, treatment and period as fixed effects and participant as a random effect. Baseline is the FEV1 value recorded pre-dose on Day 1 of each treatment period; mean Baseline is the mean of the Baselines for each participant and period Baseline is the difference between the Baseline and the mean Baseline in each treatment period for each participant. Change from Baseline for each treatment period is the trough FEV1 at Day 15 minus the Baseline value for that treatment period.
Outcome measures
| Measure |
Placebo
n=150 Participants
Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
|
UMEC 62.5 µg QD
n=34 Participants
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 125 µg QD
n=33 Participants
Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 250 µg QD
n=35 Participants
Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 500 µg QD
n=37 Participants
Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 1000 µg QD
n=29 Participants
Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 62.5 µg BID
n=31 Participants
Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 125 µg BID
n=33 Participants
Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 250 µg BID
n=32 Participants
Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
Tio 18 µg QD
n=34 Participants
Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 15 of Each Treatment Period
|
-0.047 Liters
Standard Error 0.017
|
0.081 Liters
Standard Error 0.033
|
0.099 Liters
Standard Error 0.034
|
0.048 Liters
Standard Error 0.033
|
0.092 Liters
Standard Error 0.032
|
0.138 Liters
Standard Error 0.036
|
0.032 Liters
Standard Error 0.035
|
0.087 Liters
Standard Error 0.034
|
0.124 Liters
Standard Error 0.034
|
0.058 Liters
Standard Error 0.033
|
SECONDARY outcome
Timeframe: Baseline and Day 14 of each treatment period (TP; up to Study Day 70)Population: mITT Population. All participants with \>=1 post-Baseline assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 14.
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The weighted mean FEV1 was calculated using 0-24 hour (h) post-dose measurements at Day 14 of each treatment period, which included pre-dose and post-dose 1, 3, 6, 9, 12, 13, 15, 18, 21 and 24 hours. Analysis performed using a mixed model with covariates mean BL, period BL, treatment and period as fixed effects and participant as a random effect. BL is the FEV1 value recorded pre-dose on Day 1 of each TP; mean BL is the mean of the BLs for each participant and period BL is the difference between the BL and the mean BL in each TP for each participant. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.
Outcome measures
| Measure |
Placebo
n=143 Participants
Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
|
UMEC 62.5 µg QD
n=33 Participants
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 125 µg QD
n=33 Participants
Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 250 µg QD
n=34 Participants
Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 500 µg QD
n=36 Participants
Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 1000 µg QD
n=29 Participants
Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 62.5 µg BID
n=30 Participants
Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 125 µg BID
n=32 Participants
Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 250 µg BID
n=31 Participants
Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
Tio 18 µg QD
n=33 Participants
Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours Obtained Post-dose on Day 14 of Each Treatment Period
|
-0.059 Liters
Standard Error 0.014
|
0.085 Liters
Standard Error 0.025
|
0.077 Liters
Standard Error 0.025
|
0.077 Liters
Standard Error 0.025
|
0.072 Liters
Standard Error 0.024
|
0.080 Liters
Standard Error 0.027
|
0.062 Liters
Standard Error 0.026
|
0.083 Liters
Standard Error 0.025
|
0.075 Liters
Standard Error 0.026
|
0.069 Liters
Standard Error 0.025
|
SECONDARY outcome
Timeframe: Baseline and Day (D) 14 of each treatment period (TP; up to Study Day 70)Population: mITT Population. All par. with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. Different par. may have been analyzed at different time points (n=X, X, X, X in the category titles), so the overall number of par. analyzed reflects everyone in the mITT Population with data available at \>=1 time point.
Serial FEV1 for OQ dosing is recorded at the pre-AM dose (time 0 h) and at 1, 3, 6, 9, 12,13, 15, 18, 21, 24 and 28 hs after the AM dose on D 14. For BID dosing, the 12 h AM dose corresponds to the pre-PM dose, 13 h AM dose corresponds to the 1 h PM dose, 15 h AM dose corresponds to the 3 h PM dose, 18 h AM corresponds to the 6 h PM dose, 21 h AM dose corresponds to 9 h PM dose, 24 h AM dose corresponds to the 12 h PM dose and 28 h AM dose corresponds to the 16 h PM dose in the table. Analysis performed using a mixed model with covariates of mean BL, period BL, trt, period, time, time by period BL interaction, time by mean BL interaction and time by trt interaction as fixed effects and par. as a random effect. BL is the FEV1 value recorded pre-dose on D 1 of each TP; mean BL is the mean of the BLs for each par. and period BL is the difference between the BL and the mean BL in each TP for each par. Change from BL for each TP is the trough FEV1 at Day 15 minus the BL value for that TP.
Outcome measures
| Measure |
Placebo
n=152 Participants
Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
|
UMEC 62.5 µg QD
n=34 Participants
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 125 µg QD
n=33 Participants
Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 250 µg QD
n=35 Participants
Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 500 µg QD
n=37 Participants
Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 1000 µg QD
n=30 Participants
Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 62.5 µg BID
n=32 Participants
Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 125 µg BID
n=33 Participants
Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 250 µg BID
n=32 Participants
Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
Tio 18 µg QD
n=34 Participants
Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
Pre-AM dose, n=152,34,33,35,37,30,32,33,32,34
|
-0.002 Liters
Standard Deviation 0.016
|
0.140 Liters
Standard Deviation 0.031
|
0.101 Liters
Standard Deviation 0.032
|
0.167 Liters
Standard Deviation 0.031
|
0.095 Liters
Standard Deviation 0.030
|
0.120 Liters
Standard Deviation 0.033
|
0.096 Liters
Standard Deviation 0.032
|
0.139 Liters
Standard Deviation 0.032
|
0.152 Liters
Standard Deviation 0.032
|
0.129 Liters
Standard Deviation 0.031
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
1 hour AM, n=151,34,31,35,37,29,32,33,32,34
|
0.022 Liters
Standard Deviation 0.018
|
0.246 Liters
Standard Deviation 0.035
|
0.164 Liters
Standard Deviation 0.037
|
0.140 Liters
Standard Deviation 0.035
|
0.056 Liters
Standard Deviation 0.034
|
0.072 Liters
Standard Deviation 0.038
|
0.159 Liters
Standard Deviation 0.037
|
0.132 Liters
Standard Deviation 0.036
|
0.142 Liters
Standard Deviation 0.037
|
0.229 Liters
Standard Deviation 0.036
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
3 hour AM, n=150,34,32,35,37,29,31,33,32,34
|
-0.003 Liters
Standard Deviation 0.017
|
0.157 Liters
Standard Deviation 0.034
|
0.158 Liters
Standard Deviation 0.035
|
0.222 Liters
Standard Deviation 0.034
|
0.142 Liters
Standard Deviation 0.033
|
0.148 Liters
Standard Deviation 0.037
|
0.153 Liters
Standard Deviation 0.036
|
0.112 Liters
Standard Deviation 0.035
|
0.153 Liters
Standard Deviation 0.036
|
0.191 Liters
Standard Deviation 0.035
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
6 hour AM, n=151,34,33,35,37,30,32,33,31,34
|
-0.019 Liters
Standard Deviation 0.016
|
0.137 Liters
Standard Deviation 0.031
|
0.114 Liters
Standard Deviation 0.032
|
0.149 Liters
Standard Deviation 0.031
|
0.120 Liters
Standard Deviation 0.030
|
0.105 Liters
Standard Deviation 0.034
|
0.090 Liters
Standard Deviation 0.033
|
0.100 Liters
Standard Deviation 0.032
|
0.141 Liters
Standard Deviation 0.033
|
0.152 Liters
Standard Deviation 0.032
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
9 hour AM, n=149,33,33,34,37,30,31,32,32,33
|
-0.033 Liters
Standard Deviation 0.016
|
0.121 Liters
Standard Deviation 0.033
|
0.077 Liters
Standard Deviation 0.033
|
0.123 Liters
Standard Deviation 0.032
|
0.118 Liters
Standard Deviation 0.031
|
0.076 Liters
Standard Deviation 0.035
|
0.105 Liters
Standard Deviation 0.034
|
0.104 Liters
Standard Deviation 0.033
|
0.099 Liters
Standard Deviation 0.034
|
0.105 Liters
Standard Deviation 0.033
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
12 hour AM, n=150,34,33,34,37,30,31,32,32,33
|
-0.068 Liters
Standard Deviation 0.018
|
0.087 Liters
Standard Deviation 0.035
|
0.083 Liters
Standard Deviation 0.036
|
0.084 Liters
Standard Deviation 0.035
|
0.096 Liters
Standard Deviation 0.034
|
0.074 Liters
Standard Deviation 0.038
|
0.058 Liters
Standard Deviation 0.037
|
0.099 Liters
Standard Deviation 0.036
|
0.074 Liters
Standard Deviation 0.036
|
0.153 Liters
Standard Deviation 0.036
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
13 hour AM, n=147,33,33,35,37,29,31,33,32,33
|
-0.082 Liters
Standard Deviation 0.016
|
0.071 Liters
Standard Deviation 0.031
|
0.077 Liters
Standard Deviation 0.031
|
0.071 Liters
Standard Deviation 0.031
|
0.103 Liters
Standard Deviation 0.030
|
0.096 Liters
Standard Deviation 0.033
|
0.066 Liters
Standard Deviation 0.032
|
0.018 Liters
Standard Deviation 0.032
|
0.048 Liters
Standard Deviation 0.032
|
0.065 Liters
Standard Deviation 0.031
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
15 hour AM, n=151,34,33,35,37,29,30,33,32,34
|
-0.085 Liters
Standard Deviation 0.016
|
0.074 Liters
Standard Deviation 0.031
|
0.051 Liters
Standard Deviation 0.032
|
0.069 Liters
Standard Deviation 0.031
|
0.038 Liters
Standard Deviation 0.030
|
0.050 Liters
Standard Deviation 0.033
|
0.085 Liters
Standard Deviation 0.033
|
0.054 Liters
Standard Deviation 0.032
|
0.096 Liters
Standard Deviation 0.032
|
0.036 Liters
Standard Deviation 0.031
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
18 hour AM, n=148,33,33,35,36,29,31,33,32,34
|
-0.145 Liters
Standard Deviation 0.016
|
-0.053 Liters
Standard Deviation 0.033
|
0.002 Liters
Standard Deviation 0.033
|
-0.018 Liters
Standard Deviation 0.032
|
-0.007 Liters
Standard Deviation 0.031
|
0.001 Liters
Standard Deviation 0.035
|
-0.020 Liters
Standard Deviation 0.034
|
0.016 Liters
Standard Deviation 0.033
|
-0.048 Liters
Standard Deviation 0.033
|
-0.097 Liters
Standard Deviation 0.032
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
21 hour AM, n=150,34,33,35,37,29,29,33,32,34
|
-0.147 Liters
Standard Deviation 0.017
|
0.009 Liters
Standard Deviation 0.034
|
0.035 Liters
Standard Deviation 0.034
|
-0.036 Liters
Standard Deviation 0.034
|
0.004 Liters
Standard Deviation 0.033
|
0.006 Liters
Standard Deviation 0.037
|
-0.059 Liters
Standard Deviation 0.036
|
0.029 Liters
Standard Deviation 0.035
|
-0.005 Liters
Standard Deviation 0.035
|
-0.060 Liters
Standard Deviation 0.034
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
24 hour AM, n=150,34,33,35,37,29,31,33,32,34
|
-0.051 Liters
Standard Deviation 0.017
|
0.067 Liters
Standard Deviation 0.033
|
0.093 Liters
Standard Deviation 0.034
|
0.045 Liters
Standard Deviation 0.033
|
0.088 Liters
Standard Deviation 0.032
|
0.142 Liters
Standard Deviation 0.036
|
0.021 Liters
Standard Deviation 0.035
|
0.091 Liters
Standard Deviation 0.034
|
0.139 Liters
Standard Deviation 0.035
|
0.047 Liters
Standard Deviation 0.033
|
|
Change From Baseline (BL) in Serial FEV1 Over 0-28 Hours After the Morning Dose at Day 14 of Each Treatment Period
28 hour AM, n=145,34,33,35,37,29,31,33,32,34
|
0.065 Liters
Standard Deviation 0.018
|
0.179 Liters
Standard Deviation 0.035
|
0.177 Liters
Standard Deviation 0.036
|
0.212 Liters
Standard Deviation 0.035
|
0.143 Liters
Standard Deviation 0.034
|
0.191 Liters
Standard Deviation 0.038
|
0.164 Liters
Standard Deviation 0.037
|
0.219 Liters
Standard Deviation 0.036
|
0.185 Liters
Standard Deviation 0.037
|
0.108 Liters
Standard Deviation 0.035
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
UMEC 62.5 µg QD
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
UMEC 125 µg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
UMEC 250 µg QD
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
UMEC 500 µg QD
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
UMEC 1000 µg QD
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
UMEC 62.5 µg BID
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
UMEC 125 µg BID
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
UMEC 250 µg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Tio 18 µg QD
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=158 participants at risk
Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
|
UMEC 62.5 µg QD
n=35 participants at risk
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 125 µg QD
n=34 participants at risk
Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 250 µg QD
n=36 participants at risk
Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 500 µg QD
n=38 participants at risk
Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 1000 µg QD
n=32 participants at risk
Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 62.5 µg BID
n=34 participants at risk
Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 125 µg BID
n=37 participants at risk
Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 250 µg BID
n=33 participants at risk
Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
Tio 18 µg QD
n=35 participants at risk
Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.8%
1/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.7%
1/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.8%
1/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
Other adverse events
| Measure |
Placebo
n=158 participants at risk
Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
|
UMEC 62.5 µg QD
n=35 participants at risk
Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 125 µg QD
n=34 participants at risk
Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 250 µg QD
n=36 participants at risk
Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 500 µg QD
n=38 participants at risk
Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 1000 µg QD
n=32 participants at risk
Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
|
UMEC 62.5 µg BID
n=34 participants at risk
Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 125 µg BID
n=37 participants at risk
Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
UMEC 250 µg BID
n=33 participants at risk
Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
|
Tio 18 µg QD
n=35 participants at risk
Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.63%
1/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.9%
1/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.8%
1/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
10.5%
4/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
6.2%
2/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
6.1%
2/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.3%
2/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.6%
1/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.7%
1/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
6.1%
2/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.63%
1/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
5.4%
2/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.63%
1/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.6%
1/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.1%
1/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.63%
1/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.6%
1/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.1%
1/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.1%
1/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Nervous system disorders
Headache
|
2.5%
4/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.9%
1/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.9%
1/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
8.3%
3/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.6%
1/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
6.2%
2/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.7%
1/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
9.1%
3/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
5.7%
2/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
5.6%
2/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
6.2%
2/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.9%
1/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
6.1%
2/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Nervous system disorders
Migraine
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.0%
1/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
2/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
5.6%
2/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
12.5%
4/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
5.9%
2/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Infections and infestations
Cystitis
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.7%
1/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.0%
1/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.63%
1/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.0%
1/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Gastrointestinal disorders
Dry mouth
|
0.63%
1/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.6%
1/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
6.2%
2/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.7%
1/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
9.1%
3/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.9%
1/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.9%
1/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.0%
1/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Vascular disorders
Hypertension
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
5.9%
2/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
2.8%
1/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.1%
1/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.1%
1/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.1%
1/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.0%
1/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Investigations
Blood potassium increased
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.0%
1/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/158 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/36 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/38 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
3.1%
1/32 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/34 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/37 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/33 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
0.00%
0/35 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 10 weeks.
On-treatment AEs and non-serious AEs are reported for members of the mITT Population, comprised of all participants who were randomized to treatment and who had received at least one dose of randomized study medication during treatment period.
|
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