Trial Outcomes & Findings for Study of Ambrisentan in Participants With Pulmonary Hypertension (NCT NCT00777920)
NCT ID: NCT00777920
Last Updated: 2020-09-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
140 participants
Primary outcome timeframe
First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)
Results posted on
2020-09-30
Participant Flow
Participants were enrolled at study sites in Argentina, Australia, Brazil, Canada, Chile, Mexico, Russia, Ukraine, and United States. The first participant was screened on 17 November 2008. The last study observation occurred on 11 September 2019.
140 participants were screened.
Participant milestones
| Measure |
Ambrisentan
Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
|
|---|---|
|
Overall Study
STARTED
|
140
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
50
|
Reasons for withdrawal
| Measure |
Ambrisentan
Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
|
|---|---|
|
Overall Study
Adverse Event
|
39
|
|
Overall Study
Withdrawal of Consent
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Investigator's discretion
|
1
|
|
Overall Study
Clinical status did not improve
|
1
|
|
Overall Study
Other, not specified
|
4
|
Baseline Characteristics
Study of Ambrisentan in Participants With Pulmonary Hypertension
Baseline characteristics by cohort
| Measure |
Ambrisentan
n=140 Participants
Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
|
|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
18 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
31 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
13 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose date of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks)Population: The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
Outcome measures
| Measure |
Ambrisentan
n=140 Participants
Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
|
|---|---|
|
Percentage of Participants With Adverse Events (AEs) Associated With Long-Term Exposure to Ambrisentan
|
90.7 percentage of participants
|
Adverse Events
Ambrisentan
Serious events: 80 serious events
Other events: 112 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Ambrisentan
n=140 participants at risk
Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
3.6%
5/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
2.9%
4/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
8.6%
12/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.9%
4/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
4/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
4.3%
6/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
2.9%
4/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Bradycardia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
2.1%
3/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure congestive
|
3.6%
5/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Cardiogenic shock
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Cardiopulmonary failure
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Cor pulmonale
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Pericarditis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Right ventricular dysfunction
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Right ventricular failure
|
9.3%
13/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
2.1%
3/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Strangulated hernia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Abdominal infection
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Breast cellulitis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Dengue fever
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Device related sepsis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Infected fistula
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Infection
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
2.1%
3/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Pertussis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
8.6%
12/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Salmonellosis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
2.9%
4/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Streptococcal sepsis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Tracheobronchitis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Vascular device infection
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Burns first degree
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
Liver function test increased
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
Staphylococcus test positive
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Fluid retention
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma stage III
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenoma
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
2.1%
3/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Product Issues
Device dislocation
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Product Issues
Device malfunction
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.3%
6/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
3/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.9%
4/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.1%
3/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Aortic stenosis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.1%
3/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Peripheral ischaemia
|
1.4%
2/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Vascular disorders
Venous thrombosis limb
|
0.71%
1/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
Other adverse events
| Measure |
Ambrisentan
n=140 participants at risk
Participants received ambrisentan 2.5 mg, 5 mg or 10 mg tablet orally once daily until such time as the investigator or participant chose to stop ambrisentan treatment, ambrisentan became commercially available, or the sponsor stopped the study.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
8.6%
12/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.9%
11/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
6.4%
9/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
13.6%
19/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Cardiac disorders
Right ventricular failure
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
8/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Eye disorders
Cataract
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.7%
8/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
6.4%
9/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.4%
16/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
9.3%
13/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
13/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.4%
9/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Chest pain
|
6.4%
9/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Fatigue
|
11.4%
16/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
29.3%
41/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
7.1%
10/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
6.4%
9/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
9.3%
13/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.9%
32/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
8.6%
12/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.1%
10/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
Heart sounds abnormal
|
7.1%
10/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
12/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
9/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.4%
9/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
13.6%
19/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
17.9%
25/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
5.7%
8/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
8.6%
12/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
10.7%
15/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
15/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.6%
26/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.0%
7/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.7%
8/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.0%
14/140 • Adverse Events: First dose of study drug up to the date of last dose plus 30 days (Maximum: approximately 550 weeks); All-Cause Mortality: First dose date up to approximately 564 weeks
The Safety Analysis Set included participants who were enrolled into the study and received at least one dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER