Pulmonary Hypertension
Conditions
Brief summary
AMB-220-E is an international, multicenter, open-label study examining the long-term safety of ambrisentan (BSF 208075) in subjects who have previously completed Myogen study NCT00046319, A Phase II, Randomized, Double-Blind, Dose-Controlled, Dose-Ranging, Multicenter Study of BSF 208075 Evaluating Exercise Capacity in Subjects with Moderate to Severe Pulmonary Arterial Hypertension.
Interventions
1, 2.5, 5, and 10 mg ambrisentan given orally once daily
Sponsors
Study design
Eligibility
Inclusion criteria
* Must have completed Visit 14/Week 24 of the NCT00046319 study. * Women of childbearing potential must have a negative urine pregnancy test at the Screening/Enrollment Visit and agree to use a reliable double barrier method of contraception until study completion and for \>=4 weeks following their final study visit. * Must have completed the Down-titration Period of NCT00046319 prior to enrollment in AMB-220-E and will meet the following additional criteria: * Subjects with a diagnosis of HIV must have stable disease status at the time of Screening/Enrollment. * Must be stable on conventional therapy for PAH for \>=4 weeks prior to the Screening Visit.
Exclusion criteria
* Chronic prostanoid therapy, or other investigational prostacyclin derivative within 4 weeks prior to the Screening Visit. * Intravenous inotrope use within 2 weeks prior to the Screening Visit. * Females who are pregnant or breastfeeding. * Contraindication to treatment with an endothelin receptor antagonist (ERA).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Week 24 (AMB-220-E baseline) to Week 334 | The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study. |
| Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Week 24 (AMB-220-E baseline) to Week 329.3 | The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study. |
| Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Week 24 (AMB-220-E baseline) to Week 329.3 | The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156) | 132 weeks (Week 24 to Week 156) | The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204) | 180 weeks (Week 24 to Week 204) | The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24]) | Week 24 (AMB-220-E baseline) | Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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). |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48) | 24 weeks (Week 24 to Week 48) | Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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). |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108) | 84 weeks (Week 24 to Week 108) | Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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). |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156) | 132 weeks (Week 24 to Week 156) | Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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). |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204) | 180 weeks (Week 24 to Week 204) | Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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). |
| Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24]) | Week 24 (AMB-220-E baseline) | Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest. |
| Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E | 24 weeks (Week 24 [baseline of AMB-220-E] to Week 48) | Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest. |
| Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E | 84 weeks (Week 24 of NCT00046319 to Week 108) | Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest. |
| Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24]) | Week 24 (AMB-220-E baseline) | The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E | 180 weeks (Week 24 of NCT00046319 to Week 204) | Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest. |
| Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24]) | Week 24 (AMB-220-E baseline) | The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent. |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48) | 24 weeks (Week 24 to Week 48) | The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent. |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108) | 84 weeks (Week 24 to Week 108) | The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent. |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156) | 132 weeks (Week 24 to Week 156) | The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent. |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204) | 180 weeks (Week 24 to Week 204) | The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent. |
| Time to Clinical Worsening of PAH | Week 0 (NCT00046319 baseline) to Week 360 | Clinical worsening of PAH was defined as death, lung transplantation, hospitalization for PAH, atrial septostomy, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Sildenafil, a type 5 phosphodiesterase (PDE-5) inhibitor, had not received regulatory approval for the treatment of PAH until late in the conduct of AMB 220 and AMB 220-E, and did not count toward clinical worsening. Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time. |
| Failure-free Treatment Status | Week 0 (NCT00046319 baseline) to Week 360 | Failure-free treatment status was defined as the time from initiation of active treatment to the first occurrence of death, lung transplantation, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time. |
| Long-term Survival | Week 24 (AMB-220-E baseline) to Week 329.3 | Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time. |
| Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E | 132 weeks (Week 24 of NCT00046319 to Week 156) | Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest. |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48) | 24 weeks (Week 24 to Week 48) | The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
| Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108) | 84 weeks (Week 24 to Week 108) | The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). |
Participant flow
Recruitment details
Participants who completed Week 24 of NCT00046319 and responded to ambrisentan were eligible for enrollment. Response to ambrisentan treatment was determined by the investigator at Week 24 of NCT00046319 based on improvement in efficacy, acceptable safety profile, and \>= 4 weeks of stable, conventional pulmonary arterial hypertension (PAH) therapy.
Pre-assignment details
No subjects failed screening. Subjects who completed an optional down-titration period at the end of NCT00046319 were re-titrated if their final dose was 5 mg or 10 mg.
Participants by arm
| Arm | Count |
|---|---|
| 1 mg The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. | 2 |
| 2.5 mg The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. | 7 |
| 5 mg The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg. | 19 |
| 10 mg The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg. | 26 |
| Total | 54 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| AMB-220-E Study Period | Adverse Event | 1 | 1 | 3 | 7 |
| AMB-220-E Study Period | Death | 0 | 0 | 1 | 1 |
| AMB-220-E Study Period | Lost to Follow-up | 0 | 1 | 1 | 1 |
| AMB-220-E Study Period | Physician Decision | 0 | 0 | 0 | 1 |
| NCT00046319 Study Period | Adverse Event | 1 | 0 | 1 | 1 |
| NCT00046319 Study Period | Lost to Follow-up | 0 | 1 | 0 | 0 |
| NCT00046319 Study Period | Sponsor discretion | 0 | 1 | 0 | 0 |
| NCT00046319 Study Period | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | 10 mg | 2.5 mg | Total | 5 mg | 1 mg |
|---|---|---|---|---|---|
| 6-minute Walk Distance | 410.7 Meters STANDARD_DEVIATION 93.79 | 400.4 Meters STANDARD_DEVIATION 85.13 | 406.9 Meters STANDARD_DEVIATION 98.56 | 398.8 Meters STANDARD_DEVIATION 111.56 | 462.0 Meters STANDARD_DEVIATION 132.94 |
| Age Continuous | 49.0 years STANDARD_DEVIATION 15.59 | 43.0 years STANDARD_DEVIATION 17.18 | 51.1 years STANDARD_DEVIATION 15.33 | 56.7 years STANDARD_DEVIATION 13.48 | 54.0 years STANDARD_DEVIATION 12.73 |
| Borg Dyspnea Index | 2.9 Score STANDARD_DEVIATION 1.81 | 1.6 Score STANDARD_DEVIATION 1.65 | 2.7 Score STANDARD_DEVIATION 1.76 | 2.8 Score STANDARD_DEVIATION 1.77 | 2.5 Score STANDARD_DEVIATION 0.71 |
| Height | 164.5 Centimeters STANDARD_DEVIATION 10.03 | 160.6 Centimeters STANDARD_DEVIATION 11.84 | 163.7 Centimeters STANDARD_DEVIATION 9.42 | 163.1 Centimeters STANDARD_DEVIATION 8.07 | 169.8 Centimeters STANDARD_DEVIATION 3.11 |
| Primary Diagnosis Anorexigen Use | 2 Participants | 0 Participants | 4 Participants | 2 Participants | 0 Participants |
| Primary Diagnosis Human immunodeficiency virus (HIV) Infection | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Primary Diagnosis Idiopathic Pulmonary Arterial Hypertension | 15 Participants | 5 Participants | 32 Participants | 12 Participants | 0 Participants |
| Primary Diagnosis Mixed Connective Tissue Disease | 5 Participants | 1 Participants | 7 Participants | 1 Participants | 0 Participants |
| Primary Diagnosis Other | 1 Participants | 0 Participants | 3 Participants | 2 Participants | 0 Participants |
| Primary Diagnosis Overlap Syndrome | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Primary Diagnosis Systemic Lupus Erythematosus | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Primary Diagnosis Systemic Sclerosis | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 4 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 20 Participants | 5 Participants | 39 Participants | 13 Participants | 1 Participants |
| Race/Ethnicity, Customized Hispanic | 5 Participants | 0 Participants | 8 Participants | 3 Participants | 0 Participants |
| Sex: Female, Male Female | 22 Participants | 6 Participants | 46 Participants | 17 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 1 Participants | 8 Participants | 2 Participants | 1 Participants |
| Weight | 76.1 Kilograms STANDARD_DEVIATION 17.96 | 68.1 Kilograms STANDARD_DEVIATION 14.97 | 74.2 Kilograms STANDARD_DEVIATION 18.51 | 74.6 Kilograms STANDARD_DEVIATION 21.32 | 66.0 Kilograms STANDARD_DEVIATION 8.49 |
| World Health Organization Class I | 4 Participants | 3 Participants | 8 Participants | 0 Participants | 1 Participants |
| World Health Organization Class II | 13 Participants | 3 Participants | 27 Participants | 11 Participants | 0 Participants |
| World Health Organization Class III | 9 Participants | 1 Participants | 19 Participants | 8 Participants | 1 Participants |
| Years Pulmonary Arterial Hypertension (PAH) Present | 4.8 Years STANDARD_DEVIATION 4.81 | 4.4 Years STANDARD_DEVIATION 3.87 | 3.9 Years STANDARD_DEVIATION 4.07 | 2.7 Years STANDARD_DEVIATION 2.91 | 2.0 Years STANDARD_DEVIATION 0 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 7 / 7 | 19 / 19 | 26 / 26 |
| serious Total, serious adverse events | 0 / 2 | 2 / 7 | 12 / 19 | 18 / 26 |
Outcome results
Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of mild severity (ie, did not interfere with routine activities and the subject may have experienced slight discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
Time frame: Week 24 (AMB-220-E baseline) to Week 329.3
Population: The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Diarrhoea NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pharyngitis | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bradycardia NOS | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anxiety | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Diverticulum NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nocturia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypercholesterolaemia | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Clubbing | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dizziness | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Somnolence | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pericardial Effusion | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Herpes Simplex | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dizziness Postural | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Respiratory Tract Infection NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hepatomegaly | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Heart Sounds Abnormal | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dry Mouth | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Neck Pain | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Blood Potassium Decreased | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Arrhythmia NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dry Skin | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nausea | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Headache | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Squamous Cell Carcinoma | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dyspnoea Exacerbated | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Rash NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Haemorrhoids | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastrooesophageal Reflux Disease | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Enanthema | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nasopharyngitis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastrointestinal Upset | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Blood Alkaline Phosphatase NOS Increased | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Epistaxis | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anorexia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastroenteritis NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Arthralgia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Erythema | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Syncope | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Flushing | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Palpitations | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Eye redness | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cardiac Murmur NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Feeling Cold | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Flatulence | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Fatigue | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Crackles Lung | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Asthenia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Abdominal Pain Upper | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Fatigue Aggravated | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Tachycardia NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Constipation | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nasal Congestion | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Scleroderma | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Thyroid Disorder | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pruritus | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nail Fungal Infection NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Muscle Cramp | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Transient Ischaemic Attack | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anaemia NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Lymphadenopathy | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Productive Cough | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Seasonal Allergy | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bundle Branch Block Right | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cyanosis NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vein Distended | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pneumonia NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | International Normalised Ratio Increased | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pain in Jaw | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Venous Stasis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Oxygen Saturation Decreased | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Insomnia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Colonic Polyp | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vertigo | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Sinusitis NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Influenza Like Illness | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Influenza | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Viral Infection NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Renal Cyst NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bronchitis NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Depression | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vision Blurred | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Oedema Peripheral | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypotension NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Abdominal Distension | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vomiting NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Skin Ulcer | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Acquired Hypothyroidism | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypokalaemia | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Weight Decreased | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pyrexia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hyperuricaemia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Chest Pain | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | White Blood Cell Count Increased | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cough | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypertension NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Sleep Apnoea Syndrome | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Influenza Like Illness | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pyrexia | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Colonic Polyp | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Rash NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Renal Cyst NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Respiratory Tract Infection NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Scleroderma | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Constipation | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Seasonal Allergy | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Sinusitis NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Skin Ulcer | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Sleep Apnoea Syndrome | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cough | 2 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Somnolence | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Squamous Cell Carcinoma | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Syncope | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Tachycardia NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Crackles Lung | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Thyroid Disorder | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Transient Ischaemic Attack | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anorexia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection NOS | 3 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vein Distended | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cyanosis NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Venous Stasis | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vertigo | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Viral Infection NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vision Blurred | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Depression | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vomiting NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Weight Decreased | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Abdominal Distension | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | White Blood Cell Count Increased | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Palpitations | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Diarrhoea NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Diverticulum NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anxiety | 2 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dizziness | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dizziness Postural | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dry Mouth | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dry Skin | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Arrhythmia NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dyspnoea Exacerbated | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Enanthema | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Epistaxis | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Erythema | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Arthralgia | 2 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Eye redness | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Fatigue | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Fatigue Aggravated | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Flatulence | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Asthenia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Feeling Cold | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Flushing | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Abdominal Pain Upper | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastroenteritis NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastrointestinal Upset | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Blood Alkaline Phosphatase NOS Increased | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastrooesophageal Reflux Disease | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Haemorrhoids | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Headache | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Heart Sounds Abnormal | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Blood Potassium Decreased | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hepatomegaly | 2 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Herpes Simplex | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypercholesterolaemia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypertension NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bradycardia NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hyperuricaemia | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypokalaemia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypotension NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Influenza | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bronchitis NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Insomnia | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Acquired Hypothyroidism | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | International Normalised Ratio Increased | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Lymphadenopathy | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bundle Branch Block Right | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Muscle Cramp | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nail Fungal Infection NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nasal Congestion | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nasopharyngitis | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cardiac Murmur NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nausea | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Neck Pain | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pericardial Effusion | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nocturia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Oedema Peripheral | 3 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Chest Pain | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Oxygen Saturation Decreased | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pain in Jaw | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pharyngitis | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Clubbing | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pneumonia NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Productive Cough | 2 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anaemia NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pruritus | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nocturia | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypercholesterolaemia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Diarrhoea NOS | 4 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | White Blood Cell Count Increased | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Skin Ulcer | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypertension NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Sinusitis NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Weight Decreased | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pruritus | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hyperuricaemia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bradycardia NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Depression | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Oedema Peripheral | 10 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypokalaemia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vomiting NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vision Blurred | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pneumonia NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypotension NOS | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Viral Infection NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anorexia | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Constipation | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Influenza | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Clubbing | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vertigo | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cyanosis NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Influenza Like Illness | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bronchitis NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Venous Stasis | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Oxygen Saturation Decreased | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Insomnia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Chest Pain | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vein Distended | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Seasonal Allergy | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | International Normalised Ratio Increased | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection NOS | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Transient Ischaemic Attack | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Rash NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Lymphadenopathy | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pain in Jaw | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Crackles Lung | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Scleroderma | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Muscle Cramp | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bundle Branch Block Right | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Thyroid Disorder | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Respiratory Tract Infection NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nail Fungal Infection NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Acquired Hypothyroidism | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Tachycardia NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pericardial Effusion | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nasal Congestion | 4 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Fatigue Aggravated | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Fatigue | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Arthralgia | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Syncope | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Flatulence | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Squamous Cell Carcinoma | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Eye redness | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anaemia NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Feeling Cold | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Asthenia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Erythema | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nasopharyngitis | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Flushing | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Renal Cyst NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Epistaxis | 4 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cough | 6 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastroenteritis NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Palpitations | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Enanthema | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pyrexia | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastrointestinal Upset | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nausea | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Arrhythmia NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cardiac Murmur NOS | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastrooesophageal Reflux Disease | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Blood Alkaline Phosphatase NOS Increased | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dyspnoea Exacerbated | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Somnolence | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Haemorrhoids | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Abdominal Pain Upper | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dry Skin | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pharyngitis | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Headache | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dry Mouth | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Abdominal Distension | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Neck Pain | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Heart Sounds Abnormal | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Productive Cough | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dizziness Postural | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Sleep Apnoea Syndrome | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hepatomegaly | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Blood Potassium Decreased | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anxiety | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Colonic Polyp | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Herpes Simplex | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dizziness | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Diverticulum NOS | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | White Blood Cell Count Increased | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Palpitations | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Abdominal Distension | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Abdominal Pain Upper | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Acquired Hypothyroidism | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anaemia NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anorexia | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Anxiety | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Arrhythmia NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Arthralgia | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Asthenia | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Blood Alkaline Phosphatase NOS Increased | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Blood Potassium Decreased | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bradycardia NOS | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bronchitis NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Bundle Branch Block Right | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cardiac Murmur NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Chest Pain | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Clubbing | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Colonic Polyp | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Constipation | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cough | 6 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Crackles Lung | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Cyanosis NOS | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Depression | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Diarrhoea NOS | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Diverticulum NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dizziness | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dizziness Postural | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dry Mouth | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dry Skin | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Dyspnoea Exacerbated | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Enanthema | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Epistaxis | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Erythema | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Eye redness | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Fatigue | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Fatigue Aggravated | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Flatulence | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Feeling Cold | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Flushing | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastroenteritis NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastrointestinal Upset | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Gastrooesophageal Reflux Disease | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Haemorrhoids | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Headache | 6 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Heart Sounds Abnormal | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hepatomegaly | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Herpes Simplex | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypercholesterolaemia | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypertension NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hyperuricaemia | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypokalaemia | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Hypotension NOS | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Influenza | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Influenza Like Illness | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Insomnia | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | International Normalised Ratio Increased | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Lymphadenopathy | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Muscle Cramp | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nail Fungal Infection NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nasal Congestion | 5 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nasopharyngitis | 5 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nausea | 5 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Neck Pain | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Nocturia | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Oedema Peripheral | 9 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Oxygen Saturation Decreased | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pain in Jaw | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pericardial Effusion | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pharyngitis | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pneumonia NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Productive Cough | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pruritus | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Pyrexia | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Rash NOS | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Renal Cyst NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Respiratory Tract Infection NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Scleroderma | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Seasonal Allergy | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Sinusitis NOS | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Skin Ulcer | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Sleep Apnoea Syndrome | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Somnolence | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Squamous Cell Carcinoma | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Syncope | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Tachycardia NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Thyroid Disorder | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Transient Ischaemic Attack | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection NOS | 6 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vein Distended | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Venous Stasis | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vertigo | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Viral Infection NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vision Blurred | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Vomiting NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Mild Severity During Long-term Ambrisentan Exposure | Weight Decreased | 1 Participants |
Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of moderate severity (ie, interfered with routine activities and subject may have experienced significant discomfort) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
Time frame: Week 24 (AMB-220-E baseline) to Week 329.3
Population: The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nasopharyngitis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cough | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Influenza | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Limb Injury NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Right Ventricular Failure | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cyanosis NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Oesophageal Candidiasis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Basal Cell Carcinoma | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Lower Respiratory Tract Infection NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Depression | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nausea Postoperative | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Urinary Tract Infection NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pyrexia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Diarrhoea NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Tooth Infection | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Anxiety | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nasal Congestion | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dizziness | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Menorrhagia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Insomnia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pulmonary Hypertension NOS Aggravated | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspepsia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bronchospasm NOS | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Activated Partial Thromboplastin Time Prolonged | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Herpes Zoster | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspnoea Exacerbated | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Migraine NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypertension NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pruritus | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspnoea NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypotension NOS | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Arthralgia | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | International Normalised Ratio Increased | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Ear Infection NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bursitis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Abdominal Distension | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Prothrombin Time Prolonged | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Epistaxis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Visual Disturbance NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Syncope | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Calcinosis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Erythema | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Back Pain | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection Viral NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Post Procedural Pain | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Fatigue | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Anaemia NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Arrhythmia NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Alanine Aminotransferase Increased | 2 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Fatigue Aggravated | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cataract | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nausea | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pneumonia NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Flushing | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Intervertebral Disc Herniation | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Vomiting NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Skin Infection | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Foot Fracture | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cellulitis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Neck Pain | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Palpitations | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gamma-glutamyltransferase Increased | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Localised Infection | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Aspartate Aminotransferase Increased | 2 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypoxia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastroenteritis NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Chest Pain | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bronchitis NOS | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pain in Limb | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastroenteritis Viral NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Oedema Peripheral | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Sinusitis NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Constipation | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastrooesophageal Reflux Disease | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Iron Deficiency Anaemia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Localised Osteoarthritis | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Otitis Media NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gingival Infection | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Angina Pectoris | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection NOS | 1 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Tooth Injury | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gout | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Contusion | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Atrial Fibrillation | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Osteoporosis NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Headache | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypokalaemia | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Sinusitis Chronic NOS | 0 Participants |
| 1 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hepatobiliary Disorders | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Oesophageal Candidiasis | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hepatobiliary Disorders | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Herpes Zoster | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Tooth Injury | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Oedema Peripheral | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypertension NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypokalaemia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Back Pain | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Neck Pain | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypotension NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Visual Disturbance NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypoxia | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nausea Postoperative | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Influenza | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Insomnia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Basal Cell Carcinoma | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nausea | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Localised Osteoarthritis | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | International Normalised Ratio Increased | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Intervertebral Disc Herniation | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Tooth Infection | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nasopharyngitis | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Iron Deficiency Anaemia | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bronchitis NOS | 3 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Limb Injury NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Alanine Aminotransferase Increased | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nasal Congestion | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Lower Respiratory Tract Infection NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Menorrhagia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Migraine NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bronchospasm NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Abdominal Distension | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Syncope | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bursitis | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Calcinosis | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Skin Infection | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cataract | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Anaemia NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cellulitis | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Sinusitis NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Chest Pain | 3 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Urinary Tract Infection NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Constipation | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Sinusitis Chronic NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Contusion | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Right Ventricular Failure | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cough | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Angina Pectoris | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cyanosis NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Vomiting NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pyrexia | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Depression | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Diarrhoea NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pulmonary Hypertension NOS Aggravated | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dizziness | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Anxiety | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspepsia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pruritus | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspnoea Exacerbated | 2 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection Viral NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspnoea NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Prothrombin Time Prolonged | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Ear Infection NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Arthralgia | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Epistaxis | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Localised Infection | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Post Procedural Pain | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Erythema | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Fatigue | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pneumonia NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Fatigue Aggravated | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Arrhythmia NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Flushing | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Palpitations | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Foot Fracture | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection NOS | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gamma-glutamyltransferase Increased | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pain in Limb | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastroenteritis NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Aspartate Aminotransferase Increased | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastroenteritis Viral NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Activated Partial Thromboplastin Time Prolonged | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Otitis Media NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastrooesophageal Reflux Disease | 1 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gingival Infection | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Osteoporosis NOS | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gout | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Headache | 0 Participants |
| 2.5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Atrial Fibrillation | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Contusion | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Abdominal Distension | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Localised Infection | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Activated Partial Thromboplastin Time Prolonged | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Alanine Aminotransferase Increased | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Anaemia NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Angina Pectoris | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Anxiety | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Arthralgia | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Arrhythmia NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Aspartate Aminotransferase Increased | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Atrial Fibrillation | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Back Pain | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Basal Cell Carcinoma | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bronchitis NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bronchospasm NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bursitis | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Calcinosis | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cataract | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cellulitis | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Chest Pain | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Constipation | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cough | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cyanosis NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Depression | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Diarrhoea NOS | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dizziness | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspepsia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspnoea Exacerbated | 5 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspnoea NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Ear Infection NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Epistaxis | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Erythema | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Fatigue | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Fatigue Aggravated | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Flushing | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Foot Fracture | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gamma-glutamyltransferase Increased | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastroenteritis NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastroenteritis Viral NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastrooesophageal Reflux Disease | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gingival Infection | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gout | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Headache | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hepatobiliary Disorders | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Herpes Zoster | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypertension NOS | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypokalaemia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypotension NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypoxia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Influenza | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Insomnia | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | International Normalised Ratio Increased | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Localised Osteoarthritis | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Intervertebral Disc Herniation | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Iron Deficiency Anaemia | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Limb Injury NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Lower Respiratory Tract Infection NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Menorrhagia | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Migraine NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nasal Congestion | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nasopharyngitis | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nausea | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nausea Postoperative | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Neck Pain | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Oedema Peripheral | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Oesophageal Candidiasis | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Osteoporosis NOS | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Otitis Media NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pain in Limb | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Palpitations | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pneumonia NOS | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Post Procedural Pain | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Prothrombin Time Prolonged | 2 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pruritus | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pulmonary Hypertension NOS Aggravated | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pyrexia | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Right Ventricular Failure | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Sinusitis Chronic NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Sinusitis NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Skin Infection | 1 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Syncope | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Tooth Infection | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Tooth Injury | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection NOS | 3 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection Viral NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Urinary Tract Infection NOS | 4 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Visual Disturbance NOS | 0 Participants |
| 5 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Vomiting NOS | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Oesophageal Candidiasis | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gout | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gingival Infection | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Vomiting NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Osteoporosis NOS | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastrooesophageal Reflux Disease | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastroenteritis Viral NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Tooth Injury | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Otitis Media NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gastroenteritis NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Gamma-glutamyltransferase Increased | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Aspartate Aminotransferase Increased | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pain in Limb | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Foot Fracture | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Flushing | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Arrhythmia NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Palpitations | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Fatigue Aggravated | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Fatigue | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Visual Disturbance NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pneumonia NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Erythema | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Epistaxis | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection NOS | 8 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Post Procedural Pain | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Ear Infection NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspnoea NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Arthralgia | 5 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Prothrombin Time Prolonged | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspnoea Exacerbated | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dyspepsia | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Anxiety | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pruritus | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Dizziness | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Diarrhoea NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Localised Infection | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pulmonary Hypertension NOS Aggravated | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Depression | 5 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cyanosis NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Upper Respiratory Tract Infection Viral NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Pyrexia | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cough | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Contusion | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Angina Pectoris | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Right Ventricular Failure | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Limb Injury NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Constipation | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Anaemia NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Sinusitis Chronic NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Chest Pain | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cellulitis | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Abdominal Distension | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Sinusitis NOS | 5 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Cataract | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Calcinosis | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Urinary Tract Infection NOS | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Skin Infection | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bursitis | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bronchospasm NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Menorrhagia | 3 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Alanine Aminotransferase Increased | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Migraine NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Lower Respiratory Tract Infection NOS | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Localised Osteoarthritis | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Syncope | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nasal Congestion | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Iron Deficiency Anaemia | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Intervertebral Disc Herniation | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Bronchitis NOS | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nasopharyngitis | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | International Normalised Ratio Increased | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Insomnia | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Basal Cell Carcinoma | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nausea | 5 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Influenza | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypoxia | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Activated Partial Thromboplastin Time Prolonged | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Nausea Postoperative | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypotension NOS | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypokalaemia | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Tooth Infection | 1 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Neck Pain | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hypertension NOS | 0 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Herpes Zoster | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Back Pain | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Oedema Peripheral | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Hepatobiliary Disorders | 4 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Headache | 2 Participants |
| 10 mg | Number of Participants With PAH Who Completed the Phase II NCT00046319 Study and Who Experienced AEs of Moderate Severity During Long-term Ambrisentan Exposure | Atrial Fibrillation | 2 Participants |
Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure
The number of participants in the AMB-220-E analysis set who experienced AEs (including serious AEs) of severe severity (ie, made it impossible to perform routine activities and the subject may have experienced intolerable discomfort or pain) that began after entering AMB-220-E (treatment-emergent AEs) and that occurred in more than 1 participant are summarized by dose group. The AMB-220-E analysis set consisted of all participants who received at least 1 dose of study drug during the AMB-220-E study.
Time frame: Week 24 (AMB-220-E baseline) to Week 334
Population: The AMB-220-E population consisted of all subjects who received at least 1 dose of study drug during the AMB-220-E study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Angina Pectoris | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Anaemia NOS | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Abdominal Pain NOS | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Ovarian Cyst | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Alanine Aminotransferase Increased | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Infection NOS | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Gastrointestinal Hemorrhage NOS | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Right Ventricular Failure | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Oedema Peripheral | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Gastrointestinal Arteriovenous Malformation | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Aspartate Aminotransferase Increased | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Syncope | 0 Participants |
| 1 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Pulmonary Hypertension NOS Aggravated | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Alanine Aminotransferase Increased | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Pulmonary Hypertension NOS Aggravated | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Right Ventricular Failure | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Syncope | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Abdominal Pain NOS | 1 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Ovarian Cyst | 1 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Anaemia NOS | 1 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Angina Pectoris | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Aspartate Aminotransferase Increased | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Gastrointestinal Arteriovenous Malformation | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Gastrointestinal Hemorrhage NOS | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Infection NOS | 0 Participants |
| 2.5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Oedema Peripheral | 0 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Aspartate Aminotransferase Increased | 0 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Oedema Peripheral | 1 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Gastrointestinal Hemorrhage NOS | 0 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Angina Pectoris | 1 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Pulmonary Hypertension NOS Aggravated | 0 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Right Ventricular Failure | 1 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Abdominal Pain NOS | 1 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Ovarian Cyst | 0 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Alanine Aminotransferase Increased | 0 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Gastrointestinal Arteriovenous Malformation | 0 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Syncope | 0 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Infection NOS | 1 Participants |
| 5 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Anaemia NOS | 1 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Pulmonary Hypertension NOS Aggravated | 4 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Infection NOS | 1 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Angina Pectoris | 1 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Right Ventricular Failure | 6 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Ovarian Cyst | 1 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Aspartate Aminotransferase Increased | 2 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Gastrointestinal Arteriovenous Malformation | 2 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Anaemia NOS | 0 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Gastrointestinal Hemorrhage NOS | 2 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Abdominal Pain NOS | 0 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Oedema Peripheral | 2 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Alanine Aminotransferase Increased | 2 Participants |
| 10 mg | Number of Participants With Pulmonary Arterial Hypertension (PAH) Who Completed the Phase II NCT00046319 Study and Who Experienced Severe Adverse Events (AEs) During Long-term Ambrisentan Exposure | Syncope | 4 Participants |
Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24])
The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).
Time frame: Week 24 (AMB-220-E baseline)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Baseline Measurement in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Baseline [Week 24]) | 406.1 Meters | Standard Deviation 97.78 |
Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24])
Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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).
Time frame: Week 24 (AMB-220-E baseline)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Baseline Measurement in Exercise Capacity as Measured by the Borg Dyspnea Index (BDI) (Baseline [Week 24]) | 2.69 Units on a Scale | Standard Deviation 1.728 |
Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24])
The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent.
Time frame: Week 24 (AMB-220-E baseline)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Baseline Measurement in Exercise Capacity as Measured by the Subject Global Assessment (SGA) (Baseline [Week 24]) | 69.5 Units on a Scale | Standard Deviation 20.49 |
Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24])
Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.
Time frame: Week 24 (AMB-220-E baseline)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 mg | Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24]) | WHO Classification I | 8 Participants |
| 1 mg | Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24]) | WHO Classification II | 27 Participants |
| 1 mg | Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24]) | WHO Classification III | 19 Participants |
| 1 mg | Baseline Measurement in Exercise Capacity as Measured by the World Health Organization (WHO) Functional Classification (Baseline [Week 24]) | WHO Classification IV | 0 Participants |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48)
The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).
Time frame: 24 weeks (Week 24 to Week 48)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (Last Observation Carried Forward [LOCF]) (Week 48) | 4.5 Meters | Standard Deviation 46.93 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108)
The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).
Time frame: 84 weeks (Week 24 to Week 108)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 108) | -10.3 Meters | Standard Deviation 73.16 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156)
The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).
Time frame: 132 weeks (Week 24 to Week 156)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 156) | -4.7 Meters | Standard Deviation 83.08 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204)
The 6MWT was conducted according to the American Thoracic Society guidelines (ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med 2002; 166(1):111-117.) Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study).
Time frame: 180 weeks (Week 24 to Week 204)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the 6-minute Walk Test (6MWT) Distance (LOCF) (Week 204) | -13.9 Meters | Standard Deviation 77.04 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108)
Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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).
Time frame: 84 weeks (Week 24 to Week 108)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 108) | 0.46 Units on a Scale | Standard Deviation 1.659 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156)
Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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).
Time frame: 132 weeks (Week 24 to Week 156)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 156) | 0.50 Units on a Scale | Standard Deviation 1.888 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204)
Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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).
Time frame: 180 weeks (Week 24 to Week 204)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 204) | 0.46 Units on a Scale | Standard Deviation 1.721 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48)
Change from baseline evaluated after 24 (baseline), 48, 108, 156, and 204 weeks of ambrisentan therapy in BDI (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).
Time frame: 24 weeks (Week 24 to Week 48)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the BDI (LOCF) (Week 48) | 0.21 Units on a Scale | Standard Deviation 1.323 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108)
The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent.
Time frame: 84 weeks (Week 24 to Week 108)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 108) | -7.4 Units on a Scale | Standard Deviation 25.79 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156)
The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent.
Time frame: 132 weeks (Week 24 to Week 156)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 156) | -5.1 Units on a Scale | Standard Deviation 25.31 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204)
The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent.
Time frame: 180 weeks (Week 24 to Week 204)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 204) | -1.9 Units on a Scale | Standard Deviation 23.69 |
Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48)
The SGA was determined using a visual-analog scale. Subjects were asked the question, How are you feeling today? and were asked to draw a vertical mark on a 100-mm horizontal line in which zero represented very poor and 100 represented excellent.
Time frame: 24 weeks (Week 24 to Week 48)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1 mg | Change From Baseline (Week 24 of NCT00046319) in Exercise Capacity as Measured by the SGA (LOCF) (Week 48) | -0.6 Units on a Scale | Standard Deviation 19.41 |
Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E
Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.
Time frame: 132 weeks (Week 24 of NCT00046319 to Week 156)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E | WHO Classification I | 10 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E | WHO Classification II | 18 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E | WHO Classification III | 24 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 132 Weeks of Treatment in AMB-220-E | WHO Classification IV | 2 Participants |
Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E
Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.
Time frame: 180 weeks (Week 24 of NCT00046319 to Week 204)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E | WHO Classification I | 10 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E | WHO Classification II | 19 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E | WHO Classification III | 23 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 180 Weeks of Treatment in AMB-220-E | WHO Classification IV | 2 Participants |
Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E
Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.
Time frame: 24 weeks (Week 24 [baseline of AMB-220-E] to Week 48)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E | WHO Classification I | 7 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E | WHO Classification II | 29 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E | WHO Classification III | 18 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 24 Weeks of Treatment in AMB-220-E | WHO Classification IV | 0 Participants |
Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E
Classes: I) PH; ordinary physical activity not limited or causes increased dyspnea, fatigue, chest pain, or presyncope. II) PH; ordinary physical activity mildly limited and causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes increased dyspnea, fatigue, chest pain, or presyncope; comfortable at rest. IV) PH; physical activity causes symptoms; signs of right heart failure; dyspnea/fatigue possibly at rest.
Time frame: 84 weeks (Week 24 of NCT00046319 to Week 108)
Population: Primary efficacy analyses were performed for the AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study). Results are presented using the last-observation-carried-forward (LOCF) imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E | WHO Classification I | 5 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E | WHO Classification II | 25 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E | WHO Classification III | 21 Participants |
| 1 mg | Exercise Capacity as Measured by the WHO Functional Classification (LOCF) After 84 Weeks of Treatment in AMB-220-E | WHO Classification IV | 3 Participants |
Failure-free Treatment Status
Failure-free treatment status was defined as the time from initiation of active treatment to the first occurrence of death, lung transplantation, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Results are presented as the Kaplan-Meier estimate (% probability) of not having treatment failure after a given time.
Time frame: Week 0 (NCT00046319 baseline) to Week 360
Population: The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the NCT00046319 study) was evaluated during the NCT00046319 and AMB-220-E study periods.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 1 mg | Failure-free Treatment Status | No treatment failure after 1 year of treatment | 89 Probability (%) | 110.672 |
| 1 mg | Failure-free Treatment Status | No treatment failure after 2 years of treatment | 77 Probability (%) | — |
| 1 mg | Failure-free Treatment Status | No treatment failure after 3 years of treatment | 74 Probability (%) | — |
| 1 mg | Failure-free Treatment Status | No treatment failure after 4 years of treatment | 70 Probability (%) | — |
Long-term Survival
Long-term survival was defined as the time from initiation of active treatment to death. Results are presented as the Kaplan-Meier estimate (% probability) of survival after a given time.
Time frame: Week 24 (AMB-220-E baseline) to Week 329.3
Population: The AMB-220-E analysis set (all subjects who received at least 1 dose of study drug during the AMB-220-E study) was evaluated during the AMB-220-E study period.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 1 mg | Long-term Survival | Survival after 2 years of treatment | 87 Probability (%) | — |
| 1 mg | Long-term Survival | Survival after 3 years of treatment | 87 Probability (%) | — |
| 1 mg | Long-term Survival | Survival after 4 years of treatment | 87 Probability (%) | — |
| 1 mg | Long-term Survival | Survival after 1 year of treatment | 94 Probability (%) | 111.873 |
Time to Clinical Worsening of PAH
Clinical worsening of PAH was defined as death, lung transplantation, hospitalization for PAH, atrial septostomy, the addition of approved prostanoid therapy, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents. Sildenafil, a type 5 phosphodiesterase (PDE-5) inhibitor, had not received regulatory approval for the treatment of PAH until late in the conduct of AMB 220 and AMB 220-E, and did not count toward clinical worsening. Results are presented as the Kaplan-Meier estimate (% probability) of not having clinical worsening after a given time.
Time frame: Week 0 (NCT00046319 baseline) to Week 360
Population: The NCT00046319 analysis set (all subjects who received at least 1 dose of study drug during the AMB-220 study) was evaluated during the NCT00046319 and AMB-220-E study periods.
| Arm | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 1 mg | Time to Clinical Worsening of PAH | No clinical worsening after 1 year of treatment | 78 Probability (%) | 116.662 |
| 1 mg | Time to Clinical Worsening of PAH | No clinical worsening after 2 years of treatment | 69 Probability (%) | — |
| 1 mg | Time to Clinical Worsening of PAH | No clinical worsening after 3 years of treatment | 60 Probability (%) | — |
| 1 mg | Time to Clinical Worsening of PAH | No clinical worsening after 4 years of treatment | 55 Probability (%) | — |