Trial Outcomes & Findings for 28-day Repeat Dose Study of GSK573719 (NCT NCT01030965)
NCT ID: NCT01030965
Last Updated: 2018-03-09
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 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
285 participants
Primary outcome timeframe
Baseline and Day 29
Results posted on
2018-03-09
Participant Flow
The study consisted of a Run-in Period of 5 to 8 days, followed by a 28-day Treatment Period. A total of 421 participants were screened; of these, 125 were screen failures, 10 were Run-in failures, 288 were randomized, and 285 received at least one dose of study drug (three participants were randomized but did not receive study drug).
Participant milestones
| Measure |
Placebo
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
|
UMEC 125 µg
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
|
UMEC 250 µg
Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
|
UMEC 500 µg
Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
72
|
71
|
|
Overall Study
COMPLETED
|
67
|
65
|
68
|
64
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
4
|
7
|
Reasons for withdrawal
| Measure |
Placebo
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
|
UMEC 125 µg
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
|
UMEC 250 µg
Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
|
UMEC 500 µg
Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
2
|
0
|
3
|
|
Overall Study
Protocol Violation
|
1
|
1
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
2
|
1
|
|
Overall Study
Protocol-defined Stopping Criteria
|
0
|
1
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
2
|
Baseline Characteristics
28-day Repeat Dose Study of GSK573719
Baseline characteristics by cohort
| Measure |
Placebo
n=71 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
|
UMEC 125 µg
n=71 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
|
UMEC 250 µg
n=72 Participants
Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
|
UMEC 500 µg
n=71 Participants
Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
|
Total
n=285 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.3 Years
STANDARD_DEVIATION 6.80 • n=5 Participants
|
60.1 Years
STANDARD_DEVIATION 8.75 • n=7 Participants
|
60.3 Years
STANDARD_DEVIATION 8.45 • n=5 Participants
|
62.6 Years
STANDARD_DEVIATION 9.30 • n=4 Participants
|
61.4 Years
STANDARD_DEVIATION 8.41 • n=21 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
47 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
162 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
70 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
69 Participants
n=4 Participants
|
275 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage & White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 29Population: Intent-to-Treat (ITT) Population: all participants randomized to treatment who received \>=1 dose of randomized study medication in the treatment period. All participants with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. The number of participants represents participants who provided data at Day 29.
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 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Outcome measures
| Measure |
Placebo
n=67 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
|
UMEC 125 µg
n=64 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
|
UMEC 250 µg
n=68 Participants
Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
|
UMEC 500 µg
n=64 Participants
Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
|
|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29
|
0.013 Liters
Standard Error 0.025
|
0.171 Liters
Standard Error 0.025
|
0.181 Liters
Standard Error 0.025
|
0.163 Liters
Standard Error 0.025
|
SECONDARY outcome
Timeframe: Baseline, Day 1, and Day 28Population: ITT Population. Participants (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 ITT Population with data avaialable at \>=1 time point.
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), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Outcome measures
| Measure |
Placebo
n=70 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
|
UMEC 125 µg
n=71 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
|
UMEC 250 µg
n=72 Participants
Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
|
UMEC 500 µg
n=70 Participants
Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
|
|---|---|---|---|---|
|
Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28
Day 1, n=70, 70, 71, 70
|
0.005 Liters
Standard Error 0.015
|
0.211 Liters
Standard Error 0.015
|
0.224 Liters
Standard Error 0.014
|
0.173 Liters
Standard Error 0.015
|
|
Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28
Day 28, n=65, 64, 68, 64
|
0.009 Liters
Standard Error 0.024
|
0.220 Liters
Standard Error 0.024
|
0.204 Liters
Standard Error 0.023
|
0.122 Liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: Baseline, Day 1, and Day 28Population: ITT Population. All participants with \>=1 post-BL assessment and non-missing covariate data are included in the analysis. Different participants may have been analyzed at different time points (represented by n=X, X, X, X in the category titles), so the overall number of participants analyzed reflects everyone in the ITT Population.
Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.
Outcome measures
| Measure |
Placebo
n=71 Participants
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
|
UMEC 125 µg
n=71 Participants
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
|
UMEC 250 µg
n=72 Participants
Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
|
UMEC 500 µg
n=71 Participants
Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
|
|---|---|---|---|---|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 1, 1 hour, n=70, 71, 72, 71
|
0.013 Liters
Standard Error 0.015
|
0.196 Liters
Standard Error 0.015
|
0.212 Liters
Standard Error 0.015
|
0.145 Liters
Standard Error 0.015
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 1, 3 hours, n=70, 71, 72, 71
|
0.008 Liters
Standard Error 0.018
|
0.255 Liters
Standard Error 0.018
|
0.274 Liters
Standard Error 0.018
|
0.227 Liters
Standard Error 0.018
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 1, 6 hours, n=70, 71, 72, 70
|
-0.004 Liters
Standard Error 0.019
|
0.232 Liters
Standard Error 0.019
|
0.221 Liters
Standard Error 0.019
|
0.186 Liters
Standard Error 0.019
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 1, 23 hours, n=70, 70, 72, 70
|
-0.036 Liters
Standard Error 0.019
|
0.171 Liters
Standard Error 0.019
|
0.186 Liters
Standard Error 0.019
|
0.107 Liters
Standard Error 0.019
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 1, 24 hours, n=69, 71, 72, 70
|
-0.002 Liters
Standard Error 0.019
|
0.211 Liters
Standard Error 0.018
|
0.216 Liters
Standard Error 0.018
|
0.153 Liters
Standard Error 0.018
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 28, 0 hours, n=67, 64, 69, 65
|
-0.017 Liters
Standard Error 0.024
|
0.165 Liters
Standard Error 0.024
|
0.203 Liters
Standard Error 0.024
|
0.140 Liters
Standard Error 0.024
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 28, 1 hour, n=67, 64, 68, 65
|
-0.008 Liters
Standard Error 0.025
|
0.207 Liters
Standard Error 0.026
|
0.182 Liters
Standard Error 0.025
|
0.067 Liters
Standard Error 0.026
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 28, 3 hours, n=67, 65, 67, 64
|
0.008 Liters
Standard Error 0.026
|
0.267 Liters
Standard Error 0.026
|
0.204 Liters
Standard Error 0.026
|
0.168 Liters
Standard Error 0.026
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 28, 6 hours, n=65, 65, 68, 64
|
-0.005 Liters
Standard Error 0.028
|
0.206 Liters
Standard Error 0.028
|
0.181 Liters
Standard Error 0.027
|
0.141 Liters
Standard Error 0.028
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 28, 23 hours, n=67, 64, 68, 64
|
-0.013 Liters
Standard Error 0.026
|
0.144 Liters
Standard Error 0.027
|
0.161 Liters
Standard Error 0.026
|
0.157 Liters
Standard Error 0.027
|
|
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Day 28, 24 hours, n=67, 64, 68, 64
|
0.024 Liters
Standard Error 0.025
|
0.204 Liters
Standard Error 0.026
|
0.192 Liters
Standard Error 0.025
|
0.170 Liters
Standard Error 0.026
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
UMEC 125 µg
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
UMEC 250 µg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
UMEC 500 µg
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=71 participants at risk
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
|
UMEC 125 µg
n=71 participants at risk
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
|
UMEC 250 µg
n=72 participants at risk
Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
|
UMEC 500 µg
n=71 participants at risk
Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
|
|---|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
1.4%
1/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/72 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/72 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
1.4%
1/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
1.4%
1/72 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
Other adverse events
| Measure |
Placebo
n=71 participants at risk
Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
|
UMEC 125 µg
n=71 participants at risk
Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
|
UMEC 250 µg
n=72 participants at risk
Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
|
UMEC 500 µg
n=71 participants at risk
Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
4.2%
3/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
4.2%
3/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
5.6%
4/72 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
8.5%
6/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
2/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
0.00%
0/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
8.3%
6/72 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
11.3%
8/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
|
Infections and infestations
Nasopharyngitis
|
4.2%
3/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
2.8%
2/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
1.4%
1/72 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the treatment period.
|
2.8%
2/71 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication up to 4 weeks.
On-treatment serious adverse events (SAEs) and non-serious AEs are reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of randomized study medication in the 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