Trial Outcomes & Findings for Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome (NCT NCT01739400)
NCT ID: NCT01739400
Last Updated: 2019-04-16
Results Overview
NOTE: The MAESTRO-OL study was exploratory in nature and no primary efficacy and safety endpoint were defined in the clinical protocol. This and the other exploratory efficacy outcome measures posted were selected to be reported as a primary endpoints. All efficacy analyses were considered exploratory. The analyses of the exploratory efficacy endpoints focused on the absolute values and on the change from DB baseline to Week 16 in the DB study and to Month 6 and Month 12 in the OL study. For missing 6MWD values in the OL study, the following imputation rules were applied: If the reason for missing data was death, a distance of zero (0) meters was imputed for all 6MWD visits from the date of death. For any other reasons, the last available value was carried forward.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
217 participants
Primary outcome timeframe
From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.
Results posted on
2019-04-16
Participant Flow
The study was conducted at 51 sites in 19 countries (geographical regions: Asia-Pacific, Eastern Europe, Latin America, North America and Western Europe).
217 of 221 subjects (111 macitentan, 110 placebo) that completed treatment in the AC-055-305/MAESTRO double-blind (DB) parent study (NCT01743001) were enrolled in the open-label (OL) study without knowledge of their study treatment allocation in the DB study (macitentan or placebo).
Participant milestones
| Measure |
DB-macitentan
All subjects treated with macitentan in the DB study (AC-055-305, NCT01743001).
|
DB-placebo
All subjects treated with placebo in the DB study (AC-055-305, NCT01743001).
|
|---|---|---|
|
Overall Study
STARTED
|
109
|
108
|
|
Overall Study
Treated With 10 mg Macitentan
|
109
|
108
|
|
Overall Study
COMPLETED
|
92
|
99
|
|
Overall Study
NOT COMPLETED
|
17
|
9
|
Reasons for withdrawal
| Measure |
DB-macitentan
All subjects treated with macitentan in the DB study (AC-055-305, NCT01743001).
|
DB-placebo
All subjects treated with placebo in the DB study (AC-055-305, NCT01743001).
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Death
|
5
|
2
|
|
Overall Study
Withdrawal by Subject
|
7
|
7
|
Baseline Characteristics
Clinical Study to Assess the Long-term Safety, Tolerability, and Efficacy of Macitentan in Subjects With Eisenmenger Syndrome
Baseline characteristics by cohort
| Measure |
DB-macitentan
n=109 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received macitentan in the DB study (AC-055-305, NCT01743001).
|
DB-placebo
n=108 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received placebo in the DB study (AC-055-305, NCT01743001).
|
Total
n=217 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.6 years
n=99 Participants
|
34.6 years
n=107 Participants
|
34.6 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
77 Participants
n=99 Participants
|
66 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
89 Participants
n=99 Participants
|
88 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
52 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
103 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other Asian
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Region of Enrollment
Asia-Pacific · Asia-Pacific
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Region of Enrollment
Asia-Pacific · Eastern Europe
|
24 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Region of Enrollment
Asia-Pacific · Latin America
|
18 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
Asia-Pacific · North America
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
Asia-Pacific · Western Europe-Israel
|
21 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Age categorical
12 - 17 years
|
12 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age categorical
18 - 55 years
|
89 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
|
Age categorical
≥ 56 years
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
WHO Functional Class (FC)
Class I
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
WHO Functional Class (FC)
Class II
|
66 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
WHO Functional Class (FC)
Class III
|
43 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
86 Participants
n=206 Participants
|
|
WHO Functional Class (FC)
Class IV
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Downs syndrome status
Yes
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Downs syndrome status
No
|
99 Participants
n=99 Participants
|
98 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Body Mass Index (BMI)
|
22.09 kg/m^2
n=99 Participants
|
22.06 kg/m^2
n=107 Participants
|
22.08 kg/m^2
n=206 Participants
|
PRIMARY outcome
Timeframe: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.NOTE: The MAESTRO-OL study was exploratory in nature and no primary efficacy and safety endpoint were defined in the clinical protocol. This and the other exploratory efficacy outcome measures posted were selected to be reported as a primary endpoints. All efficacy analyses were considered exploratory. The analyses of the exploratory efficacy endpoints focused on the absolute values and on the change from DB baseline to Week 16 in the DB study and to Month 6 and Month 12 in the OL study. For missing 6MWD values in the OL study, the following imputation rules were applied: If the reason for missing data was death, a distance of zero (0) meters was imputed for all 6MWD visits from the date of death. For any other reasons, the last available value was carried forward.
Outcome measures
| Measure |
DB-macitentan
n=109 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received macitentan in the DB study (AC-055-305, NCT01743001).
|
DB-placebo
n=108 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received placebo in the DB study (AC-055-305, NCT01743001).
|
|---|---|---|
|
Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12
6MWD at DB study baseline
|
370.6 meter (m)
Standard Deviation 74.1
|
381.6 meter (m)
Standard Deviation 76.7
|
|
Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12
6MWD at Week 16 in DB study
|
395.1 meter (m)
Standard Deviation 88.4
|
399.9 meter (m)
Standard Deviation 80.6
|
|
Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12
Change in 6MWD from DB study baseline to Week 16
|
24.4 meter (m)
Standard Deviation 71.0
|
18.2 meter (m)
Standard Deviation 53.0
|
|
Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12
6MWD at Month 6 in OL study
|
396.8 meter (m)
Standard Deviation 96.5
|
425.0 meter (m)
Standard Deviation 72.1
|
|
Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12
Change in 6MWD from DB study baseline to Month 6
|
26.2 meter (m)
Standard Deviation 77.9
|
43.4 meter (m)
Standard Deviation 51.5
|
|
Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12
6MWD at Month 12 in OL study
|
397.1 meter (m)
Standard Deviation 103.9
|
421.5 meter (m)
Standard Deviation 76.5
|
|
Change in Exercise Capacity as Measured by 6-minute Walking Distance (6MWD) Month 6 and 12
Change in 6MWD from DB study baseline to Month 12
|
26.5 meter (m)
Standard Deviation 79.8
|
39.9 meter (m)
Standard Deviation 55.1
|
PRIMARY outcome
Timeframe: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.Class I: no symptoms with exercise or at rest. No limitation of activity. Class II: No symptoms at rest but slight limitation with ordinary activities causing symptoms (e.g. short of breath with climbing stairs). Class III: may not have symptoms at rest but activities greatly limited by shortness of breath, fatigue, or near fainting. Class IV: symptoms at rest and inability to carry out any physical activity without symptoms. Patients in class IV manifest signs of right heart failure. For missing WHO FC values in the OL study, the following imputation rules were applied: If the reason for missing data was death, class IV was imputed for all WHO visits from the date of death. For any other reasons, the last available value was carried forward.
Outcome measures
| Measure |
DB-macitentan
n=109 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received macitentan in the DB study (AC-055-305, NCT01743001).
|
DB-placebo
n=108 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received placebo in the DB study (AC-055-305, NCT01743001).
|
|---|---|---|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class I at DB study baseline
|
0 Participants
|
0 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class II at DB study baseline
|
66 Participants
|
65 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class III at DB study baseline
|
43 Participants
|
43 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class IV at DB study baseline
|
0 Participants
|
0 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class I at Week 16 in DB study
|
3 Participants
|
1 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class II at Week 16 in DB study
|
70 Participants
|
77 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class III at Week 16 in DB study
|
36 Participants
|
30 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class IV at Week 16 in DB study
|
0 Participants
|
0 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
Improvement from DB study baseline to Week 16
|
10 Participants
|
15 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
Worsening from DB study baseline to Week 16
|
0 Participants
|
1 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class I at Month 6 in OL study
|
5 Participants
|
7 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class II at Month 6 in OL study
|
74 Participants
|
79 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class III at Month 6 in OL study
|
28 Participants
|
22 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class IV at Month 6 in OL study
|
2 Participants
|
0 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
Improvement from DB study baseline to Month 6
|
19 Participants
|
27 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
Worsening from DB study baseline to Month 6
|
3 Participants
|
1 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class I at Month 12 in OL study
|
5 Participants
|
7 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class II at Month 12 in OL study
|
74 Participants
|
79 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class III at Month 12 in OL study
|
28 Participants
|
22 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
WHO functional class IV at Month 12 in OL study
|
2 Participants
|
0 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
Improvement from DB study baseline to Month 12
|
20 Participants
|
31 Participants
|
|
Change in WHO Functional Class (FC) at Month 6 and 12
Worsening from DB study baseline to Month 12
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.The Borg dyspnea score rates the severity of dyspnea (difficult or labored breathing) on a scale from 0 ('Nothing at all') to 10 ('Very, very severe - maximal'). For missing Borg dyspnea index values in the OL study, the following imputation rules were applied: If the reason for missing data was death, a value of 10 was imputed for all Borg visits from the date of death. For any other reasons, the last available value was carried forward.
Outcome measures
| Measure |
DB-macitentan
n=109 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received macitentan in the DB study (AC-055-305, NCT01743001).
|
DB-placebo
n=108 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received placebo in the DB study (AC-055-305, NCT01743001).
|
|---|---|---|
|
Change in Borg Dyspnea Score at Month 6 and 12
Borg dyspnea score at DB study baseline
|
3.0 score on a scale
Standard Deviation 1.9
|
2.9 score on a scale
Standard Deviation 1.8
|
|
Change in Borg Dyspnea Score at Month 6 and 12
Borg dyspnea score at Week 16 in DB study
|
2.7 score on a scale
Standard Deviation 1.9
|
1.9 score on a scale
Standard Deviation 1.6
|
|
Change in Borg Dyspnea Score at Month 6 and 12
Change from DB study baseline to Week 16
|
-0.3 score on a scale
Standard Deviation 1.4
|
-0.2 score on a scale
Standard Deviation 1.5
|
|
Change in Borg Dyspnea Score at Month 6 and 12
Borg dyspnea score at Month 6 in OL study
|
2.8 score on a scale
Standard Deviation 2.0
|
2.5 score on a scale
Standard Deviation 1.8
|
|
Change in Borg Dyspnea Score at Month 6 and 12
Change from DB study baseline to Month 6
|
-0.1 score on a scale
Standard Deviation 2.0
|
-0.4 score on a scale
Standard Deviation 1.5
|
|
Change in Borg Dyspnea Score at Month 6 and 12
Borg dyspnea score at Month 12 in OL study
|
2.9 score on a scale
Standard Deviation 2.0
|
2.6 score on a scale
Standard Deviation 1.9
|
|
Change in Borg Dyspnea Score at Month 6 and 12
Change from DB study baseline to Month 12
|
-0.1 score on a scale
Standard Deviation 2.1
|
-0.3 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: From baseline in DB parent study (AC-055-305, NCT01743001) up to month 12 in this OL study.Population: No imputation of missing data for oxygen saturation as assessed by SpO2 was applied. Therefore out of 109 subjects 104 subjects were analyzed at month 6 and 92 subjects at month 12 in the DB-macitentan group. In the DB-placebo group out of 108 subjects 103 subjects were analyzed at month 6 and 84 subjects at month 12.
No imputation of missing data for SpO2 was applied. Oxygen saturation assessed by pulse oximetry: peripheral oxygen saturation (SpO2) at rest before the 6-minute walk test (6MWT)
Outcome measures
| Measure |
DB-macitentan
n=109 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received macitentan in the DB study (AC-055-305, NCT01743001).
|
DB-placebo
n=108 Participants
All enrolled subjects treated with macitentan in the AC-055-308 / OL study who received placebo in the DB study (AC-055-305, NCT01743001).
|
|---|---|---|
|
Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12
SpO2 at Month 6 in OL study
|
85.9 % of oxygen saturation at rest
Standard Deviation 5.9
|
87.4 % of oxygen saturation at rest
Standard Deviation 5.4
|
|
Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12
SpO2 at DB study baseline
|
84.2 % of oxygen saturation at rest
Standard Deviation 5.6
|
85.4 % of oxygen saturation at rest
Standard Deviation 5.0
|
|
Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12
SpO2 at Week 16 in DB study
|
85.3 % of oxygen saturation at rest
Standard Deviation 5.8
|
85.6 % of oxygen saturation at rest
Standard Deviation 5.4
|
|
Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12
Change in SpO2 from DB study baseline to Week 16
|
1.1 % of oxygen saturation at rest
Standard Deviation 4.0
|
0.2 % of oxygen saturation at rest
Standard Deviation 4.5
|
|
Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12
Change in SpO2 from DB study baseline to Month 6
|
1.5 % of oxygen saturation at rest
Standard Deviation 4.9
|
2.0 % of oxygen saturation at rest
Standard Deviation 4.3
|
|
Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12
SpO2 at Month 12 in OL study
|
86.4 % of oxygen saturation at rest
Standard Deviation 6.3
|
87.1 % of oxygen saturation at rest
Standard Deviation 5.0
|
|
Change in Peripheral Oxygen Saturation (SpO2) at Rest at Month 6 and 12
Change in SpO2 from DB study baseline to Month 12
|
2.0 % of oxygen saturation at rest
Standard Deviation 4.4
|
1.6 % of oxygen saturation at rest
Standard Deviation 4.9
|
Adverse Events
All-enrolled Analysis Set
Serious events: 62 serious events
Other events: 152 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
All-enrolled Analysis Set
n=217 participants at risk
The all-enrolled analysis set includes all subjects enrolled in AC-055-308 / MAESTRO-OL (217 subjects total). All subjects received a film-coated tablet with 10mg mactientan to be taken orally on a daily basis.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Immune system disorders
Allergy to arthropod sting
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Investigations
Antineutrophil cytoplasmic antibody positive
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Psychiatric disorders
Anxiety
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Appendicitis perforated
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Arrhythmia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Vascular disorders
Arterial perforation
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Atrial fibrillation
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Brain abscess
|
0.92%
2/217 • Number of events 2 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Bronchitis viral
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Cardiac arrest
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Cardiac failure
|
1.4%
3/217 • Number of events 4 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Cardiogenic shock
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
General disorders
Chest discomfort
|
0.92%
2/217 • Number of events 2 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
General disorders
Chest pain
|
1.4%
3/217 • Number of events 3 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Psychiatric disorders
Depression
|
0.46%
1/217 • Number of events 2 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Nervous system disorders
Dizziness
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Surgical and medical procedures
Drug therapy
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Gastrointestinal disorders
Dyschezia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
General disorders
General physical health deterioration
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.1%
9/217 • Number of events 11 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Nervous system disorders
Haemorrhagic transformation stroke
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Herpes zoster
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Nervous system disorders
Ischaemic stroke
|
0.92%
2/217 • Number of events 2 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Reproductive system and breast disorders
Ovarian cyst ruptured
|
0.92%
2/217 • Number of events 2 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Investigations
Oxygen saturation decreased
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Vascular disorders
Peripheral ischaemia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Peritonitis
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Pneumonia
|
2.3%
5/217 • Number of events 5 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Postoperative wound infection
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
1.4%
3/217 • Number of events 3 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
1.8%
4/217 • Number of events 4 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
3/217 • Number of events 3 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary infarction
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Pyelonephritis acute
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Respiratory tract infection
|
0.46%
1/217 • Number of events 2 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Eye disorders
Retinal artery embolism
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Right ventricular failure
|
2.8%
6/217 • Number of events 7 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Sepsis
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Surgical and medical procedures
Surgery
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Nervous system disorders
Syncope
|
0.92%
2/217 • Number of events 2 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Tuberculous pleurisy
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Renal and urinary disorders
Urinary retention
|
0.46%
1/217 • Number of events 2 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Cardiac disorders
Ventricular fibrillation
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Viral pharyngitis
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Wound infection
|
0.46%
1/217 • Number of events 1 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
Other adverse events
| Measure |
All-enrolled Analysis Set
n=217 participants at risk
The all-enrolled analysis set includes all subjects enrolled in AC-055-308 / MAESTRO-OL (217 subjects total). All subjects received a film-coated tablet with 10mg mactientan to be taken orally on a daily basis.
|
|---|---|
|
Infections and infestations
Bronchitis
|
9.2%
20/217 • Number of events 27 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
General disorders
Chest pain
|
6.0%
13/217 • Number of events 13 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.6%
23/217 • Number of events 28 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
18/217 • Number of events 20 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Nervous system disorders
Dizziness
|
8.3%
18/217 • Number of events 20 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
General disorders
Fatigue
|
5.1%
11/217 • Number of events 11 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Investigations
Haemoglobin decreased
|
9.2%
20/217 • Number of events 29 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
11.1%
24/217 • Number of events 42 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Nervous system disorders
Headache
|
13.4%
29/217 • Number of events 34 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
General disorders
Oedema peripheral
|
6.5%
14/217 • Number of events 15 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Upper respiratory tract infection
|
28.1%
61/217 • Number of events 119 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
9.7%
21/217 • Number of events 35 • From open label study treatment initiation up to 30 days after study treatment discontinuation (max. 24 months + 30 days).
All 217 subjects enrolled in this single-arm open-label (OL) study received 10 mg macitentan to be taken daily and are therefore presented as one group (= all-enrolled analysis set) to report the adverse events in this OL study. From these 217 total subjects 109 received macitentan and 108 placebo in the parent double-blind (DB) study (AC-055-305/MAESTRO, NCT01743001).
|
Additional Information
Clinical Trial Disclosure Desk
Actelion Pharmaceuticals Ltd.
Phone: +41 61 565 6565
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Any study-related article or abstract written independently by investigators must be submitted to Actelion for review at least 60 days prior to submission for publication or presentation. The list of authors of any formal publication or presentation of study results may include, as appropriate, representatives of Actelion, and will be determined by mutual agreement.
- Publication restrictions are in place
Restriction type: OTHER