Trial Outcomes & Findings for Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension (NCT NCT00423592)
NCT ID: NCT00423592
Last Updated: 2013-06-17
Results Overview
The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Week 12
Results posted on
2013-06-17
Participant Flow
Participant milestones
| Measure |
Ambrisentan
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
Completed Preliminary Analysis Cut-off
|
34
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Ambrisentan
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Overall Study
Adverse Event (through Week 12)
|
2
|
|
Overall Study
Adverse Event (post Week 12)
|
5
|
Baseline Characteristics
Phase 2 Study of Ambrisentan for Liver Function Test Rescue in Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Ambrisentan
n=36 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
14 Participants
n=5 Participants
|
|
Age Continuous
|
57.2 years
STANDARD_DEVIATION 13.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 participants
n=5 Participants
|
|
Pulmonary Arterial Hypertension Etiology
Idiopathic pulmonary arterial hypertension
|
23 participants
n=5 Participants
|
|
Pulmonary Arterial Hypertension Etiology
Familial pulmonary arterial hypertension
|
1 participants
n=5 Participants
|
|
Pulmonary Arterial Hypertension Etiology
Associated pulmonary arterial hypertension
|
12 participants
n=5 Participants
|
|
Pulmonary Arterial Hypertension Treatment
Ambrisentan only
|
11 participants
n=5 Participants
|
|
Pulmonary Arterial Hypertension Treatment
Ambrisentan/sildenafil
|
12 participants
n=5 Participants
|
|
Pulmonary Arterial Hypertension Treatment
Ambrisentan/prostanoid
|
8 participants
n=5 Participants
|
|
Pulmonary Arterial Hypertension Treatment
Ambrisentan/sildenafil/prostanoid
|
5 participants
n=5 Participants
|
|
World Health Organization (WHO) Functional Class
Class I
|
0 participants
n=5 Participants
|
|
World Health Organization (WHO) Functional Class
Class II
|
13 participants
n=5 Participants
|
|
World Health Organization (WHO) Functional Class
Class III
|
23 participants
n=5 Participants
|
|
World Health Organization (WHO) Functional Class
Class IV
|
0 participants
n=5 Participants
|
|
Baseline 6-Minute Walk Distance
|
397.2 meters
STANDARD_DEVIATION 104.59 • n=5 Participants
|
|
Body Mass Index
|
27.2 kg/m^2
STANDARD_DEVIATION 5.44 • n=5 Participants
|
|
Borg dyspnea index
|
4.2 units on a scale
STANDARD_DEVIATION 2.31 • n=5 Participants
|
|
Cardiac index
|
2.7 L/min/m^2
STANDARD_DEVIATION 1.02 • n=5 Participants
|
|
Height
|
165.1 cm
STANDARD_DEVIATION 7.22 • n=5 Participants
|
|
Mean pulmonary artery pressure
|
48.4 mmHg
STANDARD_DEVIATION 13.50 • n=5 Participants
|
|
Pulmonary arterial hypertension present
|
3.8 year
STANDARD_DEVIATION 4.99 • n=5 Participants
|
|
Pulmonary capillary wedge pressure
|
10.1 mmHg
STANDARD_DEVIATION 5.38 • n=5 Participants
|
|
Pulmonary vascular resistance
|
10.3 mmHg/L/min
STANDARD_DEVIATION 5.75 • n=5 Participants
|
|
Right atrial pressure
|
7.9 mmHg
STANDARD_DEVIATION 5.29 • n=5 Participants
|
|
Weight
|
74.1 kg
STANDARD_DEVIATION 15.36 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.
The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Ambrisentan
n=36 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug.
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.
The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 5 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of drug. Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Ambrisentan
n=36 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug.
|
0 participants
|
SECONDARY outcome
Timeframe: Week 12Population: The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety.
The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations \> 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in dose reduction. Safety analysis set included all participants who received at least 1 dose of study drug.
Outcome measures
| Measure |
Ambrisentan
n=36 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The 6MWD test is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
Outcome measures
| Measure |
Ambrisentan
n=35 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD)
|
23.4 meters
Standard Deviation 49.60
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
Change from baseline evaluated after 12 weeks of ambrisentan therapy in Borg dyspnea index (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).
Outcome measures
| Measure |
Ambrisentan
n=35 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise
|
-0.5 Units on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest.
Outcome measures
| Measure |
Ambrisentan
n=35 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class
Improved
|
15 Participants
|
|
A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class
No Change
|
18 Participants
|
|
A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class
Deteriorated
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health
|
4.6 Units on a scale
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health
|
3.4 Units on a scale
Standard Deviation 8.98
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning
|
4.4 Units on a scale
Standard Deviation 6.86
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical
|
7.2 Units on a scale
Standard Deviation 10.56
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Bodily Pain
|
3.1 Units on a scale
Standard Deviation 6.40
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - General Health
|
3.0 Units on a scale
Standard Deviation 7.45
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Vitality
|
4.5 Units on a scale
Standard Deviation 7.23
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Social Functioning
|
3.5 Units on a scale
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Emotional
|
3.9 Units on a scale
Standard Deviation 13.96
|
SECONDARY outcome
Timeframe: Baseline to Week 12Population: The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value.
The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy).
Outcome measures
| Measure |
Ambrisentan
n=28 Participants
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Mental Health
|
3.9 Units on a scale
Standard Deviation 5.78
|
Adverse Events
Ambrisentan
Serious events: 17 serious events
Other events: 36 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ambrisentan
n=36 participants at risk
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Blood and lymphatic system disorders
anaemia
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Blood and lymphatic system disorders
microcytic anaemia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
acute coronary syndrome
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
acute myocardial infarction
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
atrial fibrillation
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
atrial tachycardia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
cardiac arrest
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
coronary artery disease
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
palpitations
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
right ventricular failure
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
supraventricular tachycardia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Congenital, familial and genetic disorders
gastrointestinal arteriovenous malformation
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
diarrhoea
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
chest pain
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
infusion site pain
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
catheter site cellulitis
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
central line infection
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
gastroenteritis
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
gastroenteritis viral
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
lobar pneumonia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
pneumococcal sepsis
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
pneumonia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
staphylococcal bacteraemia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
upper respiratory tract infection
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Investigations
blood potassium increased
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Metabolism and nutrition disorders
dehydration
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Metabolism and nutrition disorders
hypokalaemia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Metabolism and nutrition disorders
hyponatraemia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
dizziness
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
dizziness postural
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
ischaemic stroke
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
sciatica
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
syncope
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Psychiatric disorders
depression
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Renal and urinary disorders
azotaemia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
chronic obstructive airways disease exacerbated
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
2.8%
1/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hypertension
|
13.9%
5/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
Other adverse events
| Measure |
Ambrisentan
n=36 participants at risk
All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
|
|---|---|
|
Blood and lymphatic system disorders
anaemia
|
22.2%
8/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Blood and lymphatic system disorders
lymphadenopathy
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
atrial fibrillation
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
bradycardia
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
coronary artery disease
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
palpitations
|
22.2%
8/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Cardiac disorders
tricuspid valve incompetence
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Ear and labyrinth disorders
vertigo
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Eye disorders
conjunctival haemorrhage
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Eye disorders
vision blurred
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
abdominal pain
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
abdominal pain upper
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
constipation
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
diarrhoea
|
19.4%
7/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
dyspepsia
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
gastrooesophageal reflux disease
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
nausea
|
25.0%
9/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
oesophagitis
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
toothache
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Gastrointestinal disorders
vomiting
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
asthenia
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
chest discomfort
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
chest pain
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
chills
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
fatigue
|
25.0%
9/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
influenza like illness
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
infusion site pain
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
non-cardiac chest pain
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
oedema peripheral
|
52.8%
19/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
General disorders
pyrexia
|
13.9%
5/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Immune system disorders
drug hypersensitivity
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
bronchitis
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
bronchitis acute
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
eye infection
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
herpes zoster
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
influenza
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
infusion site infection
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
localised infection
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
lower respiratory tract infection
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
nasopharyngitis
|
13.9%
5/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
pharyngitis
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
respiratory tract infection
|
13.9%
5/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
sinusitis
|
19.4%
7/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
upper respiratory tract infection
|
22.2%
8/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
urinary tract infection
|
16.7%
6/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Infections and infestations
viral upper respiratory tract infection
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Injury, poisoning and procedural complications
contusion
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Injury, poisoning and procedural complications
fall
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Injury, poisoning and procedural complications
post procedural pain
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Investigations
excercise capacity decreased
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Investigations
international normalised ratio increased
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Investigations
weight increased
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Metabolism and nutrition disorders
dehydration
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Metabolism and nutrition disorders
fluid retention
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Metabolism and nutrition disorders
hypokalaemia
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
16.7%
6/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Musculoskeletal and connective tissue disorders
pain in jaw
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
dizziness
|
13.9%
5/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
dizziness postural
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
headache
|
36.1%
13/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Nervous system disorders
tremor
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Psychiatric disorders
anxiety
|
16.7%
6/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Psychiatric disorders
depression
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Psychiatric disorders
insomnia
|
19.4%
7/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
16.7%
6/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
crackles lung
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
dysphonia
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exacerbated
|
33.3%
12/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea exertional
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
13.9%
5/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
pharyngolaryngeal pain
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
pleuritic pain
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary hypertension
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
rales
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
rhinitis allergic
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
wheezing
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Skin and subcutaneous tissue disorders
dry skin
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Skin and subcutaneous tissue disorders
erythema
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Skin and subcutaneous tissue disorders
pruritis
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Skin and subcutaneous tissue disorders
rash
|
11.1%
4/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Skin and subcutaneous tissue disorders
rash macular
|
5.6%
2/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Vascular disorders
flushing
|
19.4%
7/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
|
Vascular disorders
hypotension
|
8.3%
3/36 • Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER