Trial Outcomes & Findings for 24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease (NCT NCT01316913)

Last Updated: 2017-04-04

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 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline, smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

872 participants

Primary outcome timeframe

Baseline and Day 169

Results posted on

2017-04-04

Participant Flow

Participants (par.) who met eligibility criteria at Screening (Visit 1) completed a 7- to10-day run-in period and were then randomized to a 24-week treatment period. A total of 1191 par. were screened; 872 par. were randomized and 869 par. entered the treatment period.

Participant milestones

Participant milestones
Measure	UMEC 125 µg QD Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 62.5/25 µg QD Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 125/25 µg QD Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	TIO18 µg QD Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Overall Study STARTED	222	217	215	215
Overall Study COMPLETED	165	163	166	176
Overall Study NOT COMPLETED	57	54	49	39

Reasons for withdrawal

Reasons for withdrawal
Measure	UMEC 125 µg QD Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 62.5/25 µg QD Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 125/25 µg QD Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	TIO18 µg QD Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Overall Study Adverse Event	17	20	15	11
Overall Study Lack of Efficacy	22	12	9	13
Overall Study Protocol Violation	1	4	4	1
Overall Study Protocol-defined Stopping Criteria	7	8	11	6
Overall Study Lost to Follow-up	0	1	0	2
Overall Study Withdrawal by Subject	10	9	10	6

Baseline Characteristics

24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	UMEC 125 µg QD n=222 Participants Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 62.5/25 µg QD n=217 Participants Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 125/25 µg QD n=215 Participants Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	TIO18 µg QD n=215 Participants Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.	Total n=869 Participants Total of all reporting groups
Age, Continuous	64.5 Years STANDARD_DEVIATION 8.33 • n=5 Participants	65.0 Years STANDARD_DEVIATION 8.62 • n=7 Participants	63.8 Years STANDARD_DEVIATION 8.51 • n=5 Participants	65.2 Years STANDARD_DEVIATION 8.30 • n=4 Participants	64.6 Years STANDARD_DEVIATION 8.44 • n=21 Participants
Sex: Female, Male Female	74 Participants n=5 Participants	77 Participants n=7 Participants	67 Participants n=5 Participants	62 Participants n=4 Participants	280 Participants n=21 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	140 Participants n=7 Participants	148 Participants n=5 Participants	153 Participants n=4 Participants	589 Participants n=21 Participants
Race/Ethnicity, Customized African American/African Heritage	6 participants n=5 Participants	8 participants n=7 Participants	9 participants n=5 Participants	8 participants n=4 Participants	31 participants n=21 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	35 participants n=5 Participants	34 participants n=7 Participants	36 participants n=5 Participants	34 participants n=4 Participants	139 participants n=21 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	6 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	169 participants n=5 Participants	163 participants n=7 Participants	160 participants n=5 Participants	163 participants n=4 Participants	655 participants n=21 Participants
Race/Ethnicity, Customized White - Mixed Race	0 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Mixed Race	9 participants n=5 Participants	9 participants n=7 Participants	9 participants n=5 Participants	8 participants n=4 Participants	35 participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and Day 169

Population: ITT Population: all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with \>=1 post-Baseline measurement were included in the analysis.

Outcome measures

Outcome measures
Measure	UMEC 125 µg QD n=163 Participants Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 62.5/25 µg QD n=161 Participants Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 125/25 QD n=164 Participants Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	TIO18 µg QD n=175 Participants Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Change From Baseline in Clinic Visit Trough Forced Expiratory Volume in One Second (FEV1) at Day 169	0.186 Liters Standard Error 0.0178	0.208 Liters Standard Error 0.0180	0.223 Liters Standard Error 0.0179	0.149 Liters Standard Error 0.0176

SECONDARY outcome

Timeframe: Baseline and Day 168

Population: ITT Population. Par. analyzed are those with data available at the presented time point; but, all par. without missing covariate information and with \>=1 post-Baseline measurement were included in the analysis.

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 WM 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 WM was calculated at Days 1, 84, and Day 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes \[min\] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Change from BL at a particular visit was calculated as WM at that visit minus BL. Analysis was performed using a repeated measures model with covariates of treatment, BL (mean of the two assessments made 30 minutes and 5 minutes pre-dose on Day 1), smoking status, center group, day, and day by BL and day by treatment interactions.

Outcome measures

Outcome measures
Measure	UMEC 125 µg QD n=161 Participants Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 62.5/25 µg QD n=161 Participants Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 125/25 QD n=164 Participants Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	TIO18 µg QD n=172 Participants Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168	0.206 Liters Standard Error 0.0167	0.276 Liters Standard Error 0.0168	0.282 Liters Standard Error 0.0167	0.180 Liters Standard Error 0.0165

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and Week 24

Population: ITT Population. Participants analyzed are those with data available at the presented time point; but, all participants without missing covariate information and with \>=1 post-Baseline measurement were included in the analysis.

The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (\>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (\>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.

Outcome measures

Outcome measures
Measure	UMEC 125 µg QD n=104 Participants Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 62.5/25 µg QD n=114 Participants Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 125/25 QD n=117 Participants Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	TIO18 µg QD n=121 Participants Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Change From Baseline (BL) in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24	-0.19 scores on a scale Standard Error 0.041	-0.29 scores on a scale Standard Error 0.040	-0.33 scores on a scale Standard Error 0.040	-0.21 scores on a scale Standard Error 0.040

Adverse Events

UMEC 125 µg QD

Serious events: 15 serious events

Other events: 75 other events

Deaths: 0 deaths

UMEC/VI 62.5/25 µg QD

Serious events: 22 serious events

Other events: 63 other events

Deaths: 0 deaths

UMEC/VI 125/25 µg QD

Serious events: 15 serious events

Other events: 66 other events

Deaths: 0 deaths

TIO18 µg QD

Serious events: 9 serious events

Other events: 62 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	UMEC 125 µg QD n=222 participants at risk Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 62.5/25 µg QD n=217 participants at risk Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	UMEC/VI 125/25 µg QD n=215 participants at risk Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.	TIO18 µg QD n=215 participants at risk Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
Infections and infestations Nasopharyngitis	2.7% 6/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	6.5% 14/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	7.4% 16/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	7.9% 17/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Infections and infestations Upper respiratory tract infection	7.7% 17/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	2.8% 6/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	4.7% 10/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	6.5% 14/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Infections and infestations Lower respiratory tract infection	0.45% 1/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	3.7% 8/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	1.4% 3/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	0.93% 2/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Nervous system disorders Headache	11.3% 25/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	9.7% 21/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	9.3% 20/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	7.0% 15/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Musculoskeletal and connective tissue disorders Back pain	4.5% 10/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	3.7% 8/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	2.8% 6/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	5.1% 11/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.45% 1/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	3.2% 7/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	2.8% 6/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	1.9% 4/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Respiratory, thoracic and mediastinal disorders Cough	6.3% 14/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	2.3% 5/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	3.7% 8/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	2.8% 6/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.6% 8/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	1.4% 3/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	2.8% 6/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	1.4% 3/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Vascular disorders Hypertension	4.1% 9/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	0.46% 1/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	1.9% 4/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	3.3% 7/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.
Gastrointestinal disorders Diarrhoea	3.6% 8/222 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	1.8% 4/217 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	0.47% 1/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.	2.3% 5/215 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until the end of treatment (up to 24 weeks). On-treatment SAEs and non-serious AEs were reported for members of the ITT Population, comprised of all participants randomized to treatment who received at least one dose of randomized study drug in the Treatment Period.

Additional Information

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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.
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