Trial Outcomes & Findings for A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease (NCT NCT03153111)
NCT ID: NCT03153111
Last Updated: 2025-03-30
Results Overview
Percent of baseline NT-proBNP assessed at Week 24 was reported. Percent of baseline is calculated as the ratio of the Week 24 NT-proBNP value over baseline value, expressed in percentage. NT-proBNP is one of the best established cardiovascular response markers among all available surrogates in heart failure (HF).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
143 participants
Primary outcome timeframe
Week 24
Results posted on
2025-03-30
Participant Flow
Out of 143 enrolled participants, 1 participant was randomized by mistake and did not receive any dose of study drug. 142 participants received the study drug and were analyzed.
Participant milestones
| Measure |
Macitentan
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
|
Overall Study
COMPLETED
|
60
|
62
|
|
Overall Study
NOT COMPLETED
|
11
|
9
|
Reasons for withdrawal
| Measure |
Macitentan
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
|---|---|---|
|
Overall Study
Death
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
5
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
A Study to Evaluate Whether Macitentan is an Effective and Safe Treatment for Patients With Heart Failure With Preserved Ejection Fraction and Pulmonary Vascular Disease
Baseline characteristics by cohort
| Measure |
Macitentan
n=71 Participants
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
n=71 Participants
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.9 years
STANDARD_DEVIATION 10.11 • n=99 Participants
|
74.2 years
STANDARD_DEVIATION 8.25 • n=107 Participants
|
73.6 years
STANDARD_DEVIATION 9.22 • n=206 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
ARGENTINA
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
AUSTRIA
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
BRAZIL
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
BULGARIA
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
CZECH REPUBLIC
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
DENMARK
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
FRANCE
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
GERMANY
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
HUNGARY
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
ISRAEL
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
|
Region of Enrollment
POLAND
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Region of Enrollment
ROMANIA
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Region of Enrollment
RUSSIAN FEDERATION
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
SPAIN
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
SWEDEN
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
UNITED KINGDOM
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
UNITED STATES
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: Full analysis set (FAS) included participants which were randomized to double-blind study treatment.
Percent of baseline NT-proBNP assessed at Week 24 was reported. Percent of baseline is calculated as the ratio of the Week 24 NT-proBNP value over baseline value, expressed in percentage. NT-proBNP is one of the best established cardiovascular response markers among all available surrogates in heart failure (HF).
Outcome measures
| Measure |
Macitentan
n=71 Participants
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
n=71 Participants
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
|---|---|---|
|
Percent of Baseline N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Assessed at Week 24
|
108.39 percentage of baseline NT-proBNP
Geometric Coefficient of Variation 0.65
|
106.27 percentage of baseline NT-proBNP
Geometric Coefficient of Variation 0.55
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: FAS included participants which were randomized to double-blind study treatment. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this outcome measure (OM).
The KCCQ is a validated health related quality of life measure for heart failure. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Clinical summary score is one of the quality of life variable of interest derived from KCCQ. Clinical summary score is the mean of domains: physical limitations score (6 items) and total symptom score (2 items \[symptoms frequency and symptom burden\]). The score is calculated by summing domain responses and then transforming scores to a 0-100 unit scale with higher scores indicating better health status.
Outcome measures
| Measure |
Macitentan
n=69 Participants
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
n=71 Participants
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
|---|---|---|
|
Change From Baseline to Week 24 in the Clinical Summary Score Assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
|
-2.37 score on a scale
Standard Deviation 16.12
|
0.89 score on a scale
Standard Deviation 17.72
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: FAS included participants which were randomized to double-blind study treatment. Here, 'N' (number of participants analyzed) specifies all participants who were evaluated for this OM.
Physical activity is assessed by accelerometer as the proportion of time spent in light to vigorous physical activity based on a threshold of greater than (\>)100 activity counts per minute and expressed as change from baseline to Week 24.
Outcome measures
| Measure |
Macitentan
n=30 Participants
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
n=31 Participants
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
|---|---|---|
|
Change From Baseline to Week 24 in Accelerometer-assessed Proportion of Time Spent in Light to Vigourous Physical Activity
|
-0.024 proportion of time spent
Standard Deviation 0.084
|
-0.005 proportion of time spent
Standard Deviation 0.098
|
SECONDARY outcome
Timeframe: Weeks 16, 24, 36, 52Population: FAS included participants which were randomized to double-blind study treatment.
Number of participants with WHF events were reported. A WHF event includes HF death, hospitalization for WHF or an urgent visit for WHF.
Outcome measures
| Measure |
Macitentan
n=71 Participants
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
n=71 Participants
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
|---|---|---|
|
Number of Participants With Worsening of Heart Failure (WHF) Events Over 52 Weeks
Week 16
|
12 Participants
|
5 Participants
|
|
Number of Participants With Worsening of Heart Failure (WHF) Events Over 52 Weeks
Week 52
|
18 Participants
|
13 Participants
|
|
Number of Participants With Worsening of Heart Failure (WHF) Events Over 52 Weeks
Week 24
|
14 Participants
|
6 Participants
|
|
Number of Participants With Worsening of Heart Failure (WHF) Events Over 52 Weeks
Week 36
|
17 Participants
|
9 Participants
|
Adverse Events
Macitentan
Serious events: 29 serious events
Other events: 57 other events
Deaths: 2 deaths
Placebo
Serious events: 23 serious events
Other events: 54 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Macitentan
n=71 participants at risk
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
n=71 participants at risk
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Blood and lymphatic system disorders
Hypoplastic Anaemia
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Acute Right Ventricular Failure
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Angina Pectoris
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Angina Unstable
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Atrioventricular Block Complete
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Cardiac Failure Acute
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Chronic Right Ventricular Failure
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Left Ventricular Failure
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Right Ventricular Failure
|
8.5%
6/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
8.5%
6/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Eye disorders
Diabetic Retinopathy
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
General disorders
Oedema Peripheral
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Hepatobiliary disorders
Congestive Hepatopathy
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Gangrene
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Pneumonia
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Pyelonephritis Acute
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Forearm Fracture
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Ammonia Increased
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Blood Lactic Acid Increased
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Haemoglobin Decreased
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Hepatic Enzyme Increased
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Fluid Overload
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Twitching
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Carcinoma
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial Spreading Melanoma Stage Iv
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Cerebral Ischaemia
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Encephalopathy
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Syncope
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Psychiatric disorders
Mental Status Changes
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Renal and urinary disorders
Renal Impairment
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Reproductive system and breast disorders
Uterine Polyp
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash Pruritic
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Vascular disorders
Peripheral Ischaemia
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
Other adverse events
| Measure |
Macitentan
n=71 participants at risk
Participants received macitentan 10 milligrams (mg) tablet orally once a day starting from Day 1 up to Week 52.
|
Placebo
n=71 participants at risk
Participants received placebo tablet orally once a day starting from Day 1 up to Week 52.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Blood and lymphatic system disorders
Hypochromic Anaemia
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Angina Pectoris
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Atrial Flutter
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Left Ventricular Failure
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Cardiac disorders
Right Ventricular Failure
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Ascites
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
General disorders
Asthenia
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
General disorders
Fatigue
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
8.5%
6/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
General disorders
Non-Cardiac Chest Pain
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
General disorders
Oedema Peripheral
|
12.7%
9/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Bronchitis
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Conjunctivitis
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Pneumonia
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Alanine Aminotransferase Increased
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Blood Creatinine Increased
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Blood Potassium Increased
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Blood Urea Increased
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Blood Uric Acid Increased
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Brain Natriuretic Peptide Increased
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Glomerular Filtration Rate Decreased
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Haemoglobin Decreased
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Investigations
Weight Increased
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Fluid Retention
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Gout
|
8.5%
6/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Cancer
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Cerebral Ischaemia
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Dizziness
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Headache
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Lethargy
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Nervous system disorders
Syncope
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Renal and urinary disorders
Renal Failure
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Renal and urinary disorders
Renal Impairment
|
7.0%
5/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Reproductive system and breast disorders
Gynaecomastia
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
5.6%
4/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.3%
8/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
9.9%
7/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
1.4%
1/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
0.00%
0/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Vascular disorders
Hypertension
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
2.8%
2/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
|
Vascular disorders
Hypotension
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
4.2%
3/71 • Up to 17 months
Safety analysis set include all participants from full analysis set who received at least one dose of double-blind study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER