Trial Outcomes & Findings for A Study to Evaluate GSK1325760A - a Long-Term Extension Study (NCT NCT00554619)
NCT ID: NCT00554619
Last Updated: 2012-11-05
Results Overview
An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
21 participants
Primary outcome timeframe
For 140.57 weeks at maximum, starting from Week 24
Results posted on
2012-11-05
Participant Flow
Study AMB107818 was an extension study of Study AMB107816 (NCT00540436).
Participant milestones
| Measure |
GSK1325760A
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
GSK1325760A
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Liver Function Test Abnormality
|
1
|
Baseline Characteristics
A Study to Evaluate GSK1325760A - a Long-Term Extension Study
Baseline characteristics by cohort
| Measure |
GSK1325760A
n=21 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Age Continuous
|
45.6 Years
STANDARD_DEVIATION 12.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Japanese Heritage
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: For 140.57 weeks at maximum, starting from Week 24Population: Safety Population: Participants who had received at least one dose of the investigational product
An adverse event was defined as any untoward medical occurrence in a participant, temporally associated with the use of an investigational product, whether or not considered related to the investigational product.
Outcome measures
| Measure |
GSK1325760A
n=21 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Number of Participants With Any Adverse Event
|
21 participants
|
PRIMARY outcome
Timeframe: For 140.57 weeks at maximum, starting from Week 24Population: Safety Population
The severity of adverse events was assessed by the investigator; events were assigned to one of the following categories: mild, an event that was easily tolerated by the participant, causing minimal discomfort and not interfering with everyday activities; moderate, an event that was sufficiently discomforting to interfere with normal everyday activities; and severe, an event that prevented normal everyday activities.
Outcome measures
| Measure |
GSK1325760A
n=21 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Number of Participants With Adverse Events Categorized by Severity
Mild
|
12 participants
|
|
Number of Participants With Adverse Events Categorized by Severity
Moderate
|
5 participants
|
|
Number of Participants With Adverse Events Categorized by Severity
Severe
|
4 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156Population: Full Analysis Set (FAS): All participants registered, with the exception of those who did not receive any dose of the investigational product and those who had no efficacy assessment after treatment.
Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156 minus the baseline value. 6MWD was measured by a 6-minute walk test. This test measures the distance that a participant can walk in a period of 6 minutes. Imputation technique was last observation carried forward, which was used in an attempt to compensate for missing data. For each participant, missing values were replaced with the last observed value.
Outcome measures
| Measure |
GSK1325760A
n=21 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 24
|
53.55 meters
Standard Deviation 52.951
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 36
|
51.90 meters
Standard Deviation 61.141
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 48
|
59.61 meters
Standard Deviation 53.415
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 60
|
46.38 meters
Standard Deviation 56.871
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 72
|
59.86 meters
Standard Deviation 59.667
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 84
|
58.11 meters
Standard Deviation 64.244
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 96
|
49.84 meters
Standard Deviation 57.571
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 108
|
56.38 meters
Standard Deviation 67.131
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 120
|
58.66 meters
Standard Deviation 66.633
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 132
|
54.42 meters
Standard Deviation 66.402
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 144
|
54.83 meters
Standard Deviation 67.739
|
|
Mean Change From Baseline in Six Minutes Walk Distance (6MWD) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, and 156
Week 156
|
49.19 meters
Standard Deviation 78.369
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 159.85)Population: FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.
The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).
Outcome measures
| Measure |
GSK1325760A
n=21 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 24, n=21
|
-0.79 scores on a scale
Standard Deviation 1.670
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 36, n=21
|
-0.57 scores on a scale
Standard Deviation 2.254
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 48, n=20
|
-1.00 scores on a scale
Standard Deviation 2.242
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 60, n=21
|
-1.00 scores on a scale
Standard Deviation 2.372
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 72, n=18
|
-1.08 scores on a scale
Standard Deviation 2.433
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 84, n=18
|
-1.31 scores on a scale
Standard Deviation 2.438
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 96, n=17
|
-0.74 scores on a scale
Standard Deviation 2.617
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 108, n=18
|
-0.58 scores on a scale
Standard Deviation 2.574
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 120, n=16
|
-0.94 scores on a scale
Standard Deviation 2.732
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 132, n=10
|
1.30 scores on a scale
Standard Deviation 2.371
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 144, n=7
|
1.21 scores on a scale
Standard Deviation 1.776
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 156, n=4
|
-0.13 scores on a scale
Standard Deviation 1.436
|
|
Mean Change From Baseline in the Borg Dyspnea Index (BDI) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Withdrawal/Completion, n=7
|
-0.36 scores on a scale
Standard Deviation 4.308
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)Population: FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.
There are four grades for the WHO FC (Class I = none, Class IV = most severe). The WHO FC indicates the severity of Pulmonary Arterial Hypertension and is an adaptation of the New York Heart Association classification. It was assessed by the investigator. Observed data analysis (no imputation technique).
Outcome measures
| Measure |
GSK1325760A
n=21 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 24, n=21
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 24, n=21
|
11 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 24, n=21
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 36, n=21
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 36, n=21
|
11 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 36, n=21
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 48, n=21
|
11 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 48, n=21
|
9 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 48, n=21
|
1 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 60, n=21
|
11 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 60, n=21
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 60, n=21
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 72, n=20
|
8 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 72, n=20
|
12 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 72, n=20
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 84, n=19
|
9 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 84, n=19
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 84, n=19
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 96, n=19
|
9 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 96, n=19
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 96, n=19
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 108, n=19
|
9 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 108, n=19
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 108, n=19
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 120, n=18
|
8 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 120, n=18
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 120, n=18
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 132, n=13
|
5 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 132, n=13
|
8 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 132, n=13
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 144, n=10
|
3 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 144, n=10
|
7 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 144, n=10
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Week 156, n=6
|
2 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Week 156, n=6
|
4 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Week 156, n=6
|
0 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Improved at Withdrawal/Completion, n=20
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
No change at Withdrawal/Completion, n=20
|
10 participants
|
|
Number of Participants With the Indicated Change From Baseline in Their World Health Organization (WHO) Functional Classification (FC) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Deteriorated at Withdrawal/Completion, n=20
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 164.14 weeksPopulation: FAS
Time to clinical worsening was defined as the time from baseline to the first occurrence of death, lung transplantation, hospitalization for PAH treatment, atrial septostomy (a surgical procedure in which a small hole is made in the wall between the left and right atria of the heart), or study discontinuation due to change to other PAH treatment. Time to clinical worsening was measured as the number of participants who experienced these events up to 164.14 weeks.
Outcome measures
| Measure |
GSK1325760A
n=21 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event
Death
|
0 participants
|
|
Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event
Lung transplantation
|
0 participants
|
|
Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event
Hospitalization for PAH treatment
|
0 participants
|
|
Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event
Atrial septostomy
|
0 participants
|
|
Number of Participants With the Indicated Event, as an Assessment of Time to Clinical Worsening of Pulmonary Arterial Hypertension (PAH), Assessed as the First Occurrence of a Particular Event
Study discontinuation (additional medication)
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 153)Population: FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.
mPAP is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).
Outcome measures
| Measure |
GSK1325760A
n=19 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 24, n=19
|
-9.96 millimeters of mercury (mmHg)
Standard Deviation 7.419
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 36, n=19
|
-8.16 millimeters of mercury (mmHg)
Standard Deviation 8.969
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 48, n=19
|
-7.06 millimeters of mercury (mmHg)
Standard Deviation 10.064
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 60, n=18
|
-5.44 millimeters of mercury (mmHg)
Standard Deviation 14.839
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 72, n=18
|
-10.68 millimeters of mercury (mmHg)
Standard Deviation 10.661
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 84, n=15
|
-9.23 millimeters of mercury (mmHg)
Standard Deviation 14.241
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 96, n=16
|
-13.33 millimeters of mercury (mmHg)
Standard Deviation 13.108
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 108, n=16
|
-10.87 millimeters of mercury (mmHg)
Standard Deviation 10.786
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 120, n=15
|
-10.56 millimeters of mercury (mmHg)
Standard Deviation 10.011
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 132, n=10
|
-13.30 millimeters of mercury (mmHg)
Standard Deviation 10.592
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 144, n=8
|
-12.04 millimeters of mercury (mmHg)
Standard Deviation 9.364
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 156, n=6
|
-13.85 millimeters of mercury (mmHg)
Standard Deviation 8.900
|
|
Mean Change From Baseline in Mean Pulmonary Artery Pressure (mPAP) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Withdrawal/Completion, n=6
|
-10.72 millimeters of mercury (mmHg)
Standard Deviation 14.972
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 156.14)Population: FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.
CO is a measure of cardiopulmonary hemodynamics (echocardiography). Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. Observed data analysis (no imputation technique).
Outcome measures
| Measure |
GSK1325760A
n=20 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 96, n=18
|
0.025 Liters per minute (L/min)
Standard Deviation 1.3813
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 24, n=20
|
0.425 Liters per minute (L/min)
Standard Deviation 1.6453
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 36, n=20
|
0.291 Liters per minute (L/min)
Standard Deviation 1.6786
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 48, n=20
|
0.227 Liters per minute (L/min)
Standard Deviation 1.5546
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 60, n=20
|
0.430 Liters per minute (L/min)
Standard Deviation 1.2865
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 72, n=19
|
-0.002 Liters per minute (L/min)
Standard Deviation 1.4237
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 84, n=18
|
0.151 Liters per minute (L/min)
Standard Deviation 1.5211
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 108, n=17
|
0.175 Liters per minute (L/min)
Standard Deviation 1.6398
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 120, n=17
|
0.285 Liters per minute (L/min)
Standard Deviation 1.2126
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 132, n=13
|
0.068 Liters per minute (L/min)
Standard Deviation 1.4774
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 144, n=10
|
0.391 Liters per minute (L/min)
Standard Deviation 1.1643
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 156, n=5
|
0.458 Liters per minute (L/min)
Standard Deviation 0.5779
|
|
Mean Change From Baseline in Cardiac Output (CO) at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Withdrawal/Completion, n=7
|
0.257 Liters per minute (L/min)
Standard Deviation 1.1571
|
SECONDARY outcome
Timeframe: Baseline and Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion (up to Week 164.14)Population: FAS. Participants were followed for different lengths of time; thus, not all participants were analyzed at all study weeks.
Change from baseline was calculated as each value at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion minus the baseline value. BNP is a surrogate marker of heart failure and was measured by a central laboratory. Observed data analysis (no imputation techniques).
Outcome measures
| Measure |
GSK1325760A
n=21 Participants
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 84, n=19
|
-118.78 nanograms per liter (ng/L)
Standard Deviation 160.738
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 96, n=19
|
-115.73 nanograms per liter (ng/L)
Standard Deviation 146.038
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 24, n=20
|
-109.54 nanograms per liter (ng/L)
Standard Deviation 170.495
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 36, n=21
|
-96.98 nanograms per liter (ng/L)
Standard Deviation 167.736
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 48, n=21
|
-70.40 nanograms per liter (ng/L)
Standard Deviation 211.457
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 60, n=21
|
-79.89 nanograms per liter (ng/L)
Standard Deviation 232.876
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 72, n=20
|
-81.36 nanograms per liter (ng/L)
Standard Deviation 204.379
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 108, n=19
|
-117.07 nanograms per liter (ng/L)
Standard Deviation 183.770
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 120, n=18
|
-113.23 nanograms per liter (ng/L)
Standard Deviation 164.368
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 132, n=13
|
-140.93 nanograms per liter (ng/L)
Standard Deviation 215.436
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 144, n=10
|
-138.17 nanograms per liter (ng/L)
Standard Deviation 226.688
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Week 156, n=6
|
-146.52 nanograms per liter (ng/L)
Standard Deviation 218.553
|
|
Mean Change From Baseline in B-type Natriuretic Peptide (BNP) Values at Weeks 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, and Withdrawal/Completion
Withdrawal/Completion, n=20
|
-62.72 nanograms per liter (ng/L)
Standard Deviation 260.373
|
Adverse Events
GSK1325760A
Serious events: 8 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1325760A
n=21 participants at risk
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Cardiac disorders
Atrial fibrillation
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Cardiac disorders
Ventricular tachycardia
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Eye disorders
Vitreous haemorrhage
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Gastrointestinal disorders
Ascites
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Nervous system disorders
Hepatic encephalopathy
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Renal and urinary disorders
Renal failure
|
4.8%
1/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
Other adverse events
| Measure |
GSK1325760A
n=21 participants at risk
Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
85.7%
18/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
General disorders
Pyrexia
|
38.1%
8/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
7/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Gastrointestinal disorders
Diarrhoea
|
23.8%
5/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.8%
5/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.0%
4/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Gastrointestinal disorders
Gastroenteritis
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Nervous system disorders
Dizziness
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Nervous system disorders
Headache
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
3/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Infections and infestations
Cystitis
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Infections and infestations
Onychomycosis
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Gastrointestinal disorders
Toothache
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Blood and lymphatic system disorders
Leukopenia
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Vascular disorders
Flushing
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Vascular disorders
Hot flush
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Ear and labyrinth disorders
Vertigo
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.5%
2/21 • Serious adverse events (SAEs) and non-serious AEs were collected for 140.57 weeks at maximum, starting from Week 24.
|
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