Trial Outcomes & Findings for Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (NCT NCT02060721)
NCT ID: NCT02060721
Last Updated: 2025-03-30
Results Overview
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Results posted on
2025-03-30
Participant Flow
Participant milestones
| Measure |
Macitentan 10 Milligrams (mg)
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Overall Study
STARTED
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76
|
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Overall Study
COMPLETED
|
38
|
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Overall Study
NOT COMPLETED
|
38
|
Reasons for withdrawal
| Measure |
Macitentan 10 Milligrams (mg)
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Overall Study
Lost to Follow-up
|
1
|
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Overall Study
Physician Decision
|
2
|
|
Overall Study
Death
|
14
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Compliance with local regulation: enrolled in China
|
19
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Baseline Characteristics
Clinical Study to Assess the Safety, Tolerability and Efficacy of Macitentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension
Baseline characteristics by cohort
| Measure |
Macitentan 10 Milligrams (mg)
n=76 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
48 Participants
n=93 Participants
|
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Age, Categorical
>=65 years
|
28 Participants
n=93 Participants
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Age, Continuous
|
57.8 years
STANDARD_DEVIATION 13.99 • n=93 Participants
|
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Sex: Female, Male
Female
|
48 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
74 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)Population: Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs are those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=76 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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72 Participants
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PRIMARY outcome
Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)Population: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
Number of participants with AEs leading to study drug discontinuation was reported.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=76 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Number of Participants With AEs Leading to Study Drug Discontinuation
|
9 Participants
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PRIMARY outcome
Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)Population: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
A serious adverse event (SAE) is any untoward medical occurrence that at any dose resulting in any of following outcomes: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. Treatment-emergent SAEs were those events that started after administration of the first dose and up to safety follow-up visit/end of study, that is, 30 days after the last dose of study medication.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=76 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
|
44 Participants
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PRIMARY outcome
Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)Population: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
Number of participants with hemoglobin abnormalities were reported. It included hemoglobin less than (\<) 80 grams per liter (g/L), hemoglobin \<100 g/L, hemoglobin greater than or equal to (\>=) 80 g/L and \<100 g/L, hemoglobin \<100g/L and a decrease of \>20 g/L from baseline, decrease of \>20 g/L in hemoglobin from baseline, decrease of \>20 g/L and \<=50 g/L in hemoglobin from baseline, and decrease of \>50 g/L in hemoglobin from baseline.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=76 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Number of Participants With Hemoglobin Abnormalities
Hemoglobin < 80 g/L
|
0 Participants
|
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Number of Participants With Hemoglobin Abnormalities
Hemoglobin <100 g/L
|
7 Participants
|
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Number of Participants With Hemoglobin Abnormalities
Hemoglobin >= 80 g/L and <100 g/L
|
7 Participants
|
|
Number of Participants With Hemoglobin Abnormalities
Hemoglobin <100g/L and a decrease of >20 g/L from baseline
|
6 Participants
|
|
Number of Participants With Hemoglobin Abnormalities
Decrease of >20 g/L in hemoglobin from baseline
|
32 Participants
|
|
Number of Participants With Hemoglobin Abnormalities
Decrease of >20 g/L and <=50 g/L in hemoglobin from baseline
|
31 Participants
|
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Number of Participants With Hemoglobin Abnormalities
Decrease of >50 g/L in hemoglobin from baseline
|
5 Participants
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PRIMARY outcome
Timeframe: Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)Population: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
Number of participants with liver tests abnormalities were reported. It included alanine aminotransferase (ALT) or aspartate aminotransferase (AST): \>=3 x Upper limit of the normal range (ULN), \>=3 and \<5 x ULN, \>=5 ULN, and \>=5 and \<8 x ULN, \>= 8 x ULN, and total bilirubin \>=2 x ULN.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=76 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Number of Participants With Liver Tests Abnormalities
ALT or AST >=3 x ULN
|
2 Participants
|
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Number of Participants With Liver Tests Abnormalities
ALT or AST >=3 and <5 x ULN
|
1 Participants
|
|
Number of Participants With Liver Tests Abnormalities
ALT or AST >=5 x ULN
|
1 Participants
|
|
Number of Participants With Liver Tests Abnormalities
ALT or AST >=5 and <8 x ULN
|
0 Participants
|
|
Number of Participants With Liver Tests Abnormalities
ALT or AST >=8 x ULN
|
1 Participants
|
|
Number of Participants With Liver Tests Abnormalities
Total Bilirubin >=2 x ULN
|
8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure.
Change from baseline in blood pressure at Month 6 (both systolic blood pressure \[SBP\] and diastolic blood pressure \[DBP\]) was reported.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=70 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Change From Baseline in Blood Pressure at Month 6
SBP
|
-0.4 Millimeters of mercury (mmHg)
Standard Deviation 13.15
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Change From Baseline in Blood Pressure at Month 6
DBP
|
-2.8 Millimeters of mercury (mmHg)
Standard Deviation 9.51
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PRIMARY outcome
Timeframe: Baseline and Month 6Population: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure.
Change from baseline in pulse rate at Month 6 was reported.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=70 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
|
Change From Baseline in Pulse Rate at Month 6
|
-1.1 Beats per minute
Standard Deviation 8.76
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PRIMARY outcome
Timeframe: Baseline and Month 6Population: OLAS included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study. Here, 'N' (number of participants analyzed) signifies participants evaluated for this outcome measure.
Change from baseline in body weight at Month 6 was reported.
Outcome measures
| Measure |
Macitentan 10 Milligrams (mg)
n=70 Participants
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Change From Baseline in Body Weight at Month 6
|
-0.35 kilograms (kg)
Standard Deviation 2.871
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Adverse Events
Macitentan 10 Milligrams (mg)
Serious events: 44 serious events
Other events: 67 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Macitentan 10 Milligrams (mg)
n=76 participants at risk
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
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|---|---|
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Cardiac disorders
Acute Myocardial Infarction
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Cardiac disorders
Angina Pectoris
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
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Cardiac disorders
Aortic Valve Stenosis
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
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Cardiac disorders
Atrial Fibrillation
|
2.6%
2/76 • Number of events 3 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
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Cardiac disorders
Atrial Flutter
|
2.6%
2/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
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|
Cardiac disorders
Atrial Tachycardia
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Cardiac disorders
Cardiac Arrest
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Cardiac disorders
Cardiac Failure
|
5.3%
4/76 • Number of events 9 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Cardiac disorders
Cardiac Failure Acute
|
3.9%
3/76 • Number of events 3 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Cardiac disorders
Coronary Artery Disease
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Cardiac disorders
Right Ventricular Failure
|
6.6%
5/76 • Number of events 8 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Congenital, familial and genetic disorders
Arteriovenous Malformation
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Eye disorders
Cataract
|
1.3%
1/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Eye disorders
Vision Blurred
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.3%
1/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Gastrointestinal disorders
Gastric Polyps
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Gastrointestinal disorders
Gastrointestinal Motility Disorder
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Gastrointestinal disorders
Peritoneal Adhesions
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Gastrointestinal disorders
Vomiting
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
General disorders
Death
|
3.9%
3/76 • Number of events 3 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
General disorders
General Physical Health Deterioration
|
2.6%
2/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
General disorders
Peripheral Swelling
|
1.3%
1/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
General disorders
Pyrexia
|
2.6%
2/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Hepatobiliary disorders
Hepatitis
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Appendiceal Abscess
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Appendicitis
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Covid-19 Pneumonia
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Neutropenic Sepsis
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Pneumonia
|
5.3%
4/76 • Number of events 5 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Pneumonia Parainfluenzae Viral
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Pulmonary Tuberculosis
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Pyelonephritis Acute
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Pyelonephritis Chronic
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Respiratory Tract Infection
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Sepsis
|
2.6%
2/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Septic Shock
|
2.6%
2/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Streptococcal Sepsis
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Injury, poisoning and procedural complications
Chemical Burns of Eye
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Injury, poisoning and procedural complications
Head Injury
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
3.9%
3/76 • Number of events 3 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Investigations
Catheterisation Cardiac
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Investigations
Chest X-Ray Abnormal
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Investigations
Haemoglobin Decreased
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Musculoskeletal and connective tissue disorders
Systemic Lupus Erythematosus
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer Metastatic
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer Stage Iv
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Nervous system disorders
Diplegia
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Renal and urinary disorders
Haematuria
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Renal and urinary disorders
Renal Failure
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
1/76 • Number of events 3 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
2/76 • Number of events 2 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.6%
2/76 • Number of events 3 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive Airways Disorder
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian Syndrome
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.9%
3/76 • Number of events 3 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
7.9%
6/76 • Number of events 6 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep Apnoea Syndrome
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Surgical and medical procedures
Angioplasty
|
3.9%
3/76 • Number of events 10 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Surgical and medical procedures
Arterial Angioplasty
|
9.2%
7/76 • Number of events 23 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Surgical and medical procedures
Pulmonary Endarterectomy
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Vascular disorders
Air Embolism
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Vascular disorders
Hypotension
|
1.3%
1/76 • Number of events 1 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Vascular disorders
Reperfusion Injury
|
2.6%
2/76 • Number of events 3 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
Other adverse events
| Measure |
Macitentan 10 Milligrams (mg)
n=76 participants at risk
Eligible participants who were either randomized to macitentan 10 mg or placebo group during 24 weeks double-blind MERIT-1 (NCT02021292) study, were rolled-over to this open-label extension study and received macitentan 10 mg tablet orally once daily starting from Day 1 to the end of treatment (treatment exposure ranged from 1 to 82 months).
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
13.2%
10/76 • Number of events 11 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Cardiac disorders
Cardiac Failure
|
6.6%
5/76 • Number of events 5 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Eye disorders
Cataract
|
7.9%
6/76 • Number of events 7 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.2%
7/76 • Number of events 11 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
General disorders
Oedema Peripheral
|
14.5%
11/76 • Number of events 13 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
General disorders
Pyrexia
|
5.3%
4/76 • Number of events 5 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Bronchitis
|
11.8%
9/76 • Number of events 14 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Covid-19
|
7.9%
6/76 • Number of events 7 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Nasopharyngitis
|
11.8%
9/76 • Number of events 15 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
5.3%
4/76 • Number of events 4 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
15.8%
12/76 • Number of events 21 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Infections and infestations
Urinary Tract Infection
|
9.2%
7/76 • Number of events 14 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Investigations
Blood Bilirubin Increased
|
6.6%
5/76 • Number of events 6 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Investigations
Blood Creatinine Increased
|
5.3%
4/76 • Number of events 4 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Investigations
C-Reactive Protein Increased
|
7.9%
6/76 • Number of events 6 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Investigations
Haemoglobin Decreased
|
17.1%
13/76 • Number of events 17 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Investigations
Weight Decreased
|
9.2%
7/76 • Number of events 8 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
5.3%
4/76 • Number of events 4 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
4/76 • Number of events 8 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
6/76 • Number of events 9 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.2%
7/76 • Number of events 7 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
6.6%
5/76 • Number of events 5 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.9%
6/76 • Number of events 6 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Nervous system disorders
Dizziness
|
10.5%
8/76 • Number of events 15 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Nervous system disorders
Headache
|
9.2%
7/76 • Number of events 10 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Nervous system disorders
Syncope
|
9.2%
7/76 • Number of events 8 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
9/76 • Number of events 11 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.2%
7/76 • Number of events 7 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.3%
4/76 • Number of events 7 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
14.5%
11/76 • Number of events 12 • Up to 30 days after study treatment discontinuation (treatment exposure ranged from 1 to 82 months)
Open-label analysis set (OLAS) included all data from participants who were enrolled into this open-label extension study, from the time they entered this open-label extension study.
|
Additional Information
Clinical Scientific Leader
Actelion Pharmaceuticals Ltd.
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study-related publication written independently by investigators must be submitted to Actelion for review at least 30 days prior to submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER