Trial Outcomes & Findings for A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH) (NCT NCT02932410)

Last Updated: 2025-11-12

Results Overview

Observed steady-state trough (pre-dose) plasma concentration of macitentan and aprocitentan (active metabolite) at Week 12 based on body weight were reported. This outcome measure was planned to be analyzed for specified arms only.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

165 participants

Primary outcome timeframe

Pre-dose at Week 12

Results posted on

2025-11-12

Participant Flow

Eligible participants up to less than (\<) 18 years at the time of enrolment were classified into one of the treatment arms: Macitentan (greater than or equal to \[\>=\] 2 years), standard of care (SOC: \>=2 years), Macitentan (\<2 years) or China Single Arm Cohort (\>=12 years).

Participants from 2 to \<18 years were randomized (1:1) to either macitentan or to SoC. Randomization was stratified by ongoing/planned Endothelin Receptor Antagonist treatment at randomization (yes vs no) and by WHO Functional Class (FC) at randomization (FC I/II vs FC III). Participants \<2 years or participants in China single arm cohort were assigned to macitentan arm without randomization. Adverse events are reported until end of core period analysis which is beyond primary completion date.

Participant milestones

Participant milestones
Measure	Macitentan (JNJ-67896062) (>=2 Years) Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.	Standard of Care (SoC; >=2 Years) Randomized participants aged \>=2 years continued their SoC as per site's clinical practice which comprised treatment with the pulmonary arterial hypertension (PAH) non-specific treatment and/or up to 2 PAH-specific medications excluding macitentan and intravenous (IV)/subcutaneous (SC) prostanoids. Participants continued to receive the PDE-5i (sildenafil and tadalafil), or other PAH-specific treatment such as an ERA (bosentan and ambrisentan) or oral prostanoids (soluble guanylate cyclase stimulators \[riociguat\]), which was ongoing at the time of randomization. Additional PAH-specific therapy other than macitentan and IV or SC prostanoids initiated prior to randomization was continued. Participants received treatment from Day 1 up to 316.4 weeks. For participants with disease progression, crossover to macitentan was offered after confirmation of a disease progression event by the blinded Clinical Event Committee.	Macitentan (JNJ-67896062) (<2 Years) Enrolled participants aged \<2 years received macitentan 2.5 mg once daily orally (dispersible tablet reconstituted in water). Oral or inhaled prostanoid treatment were allowed as PAH-specific background therapy. Participants received treatment from Day 1 up to 72.9 weeks.	China Single-arm Cohort (>=12 to <18 Years) Enrolled participants aged \>=12 to \<18 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 (PDE-5) inhibitor was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 48.29 weeks.
Overall Study STARTED	73	75	9	8
Overall Study Treated	72	75	9	8
Overall Study Crossed Over to Macitentan Treatment	0	8	0	0
Overall Study COMPLETED	59	60	8	8
Overall Study NOT COMPLETED	14	15	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Macitentan (JNJ-67896062) (>=2 Years) Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.	Standard of Care (SoC; >=2 Years) Randomized participants aged \>=2 years continued their SoC as per site's clinical practice which comprised treatment with the pulmonary arterial hypertension (PAH) non-specific treatment and/or up to 2 PAH-specific medications excluding macitentan and intravenous (IV)/subcutaneous (SC) prostanoids. Participants continued to receive the PDE-5i (sildenafil and tadalafil), or other PAH-specific treatment such as an ERA (bosentan and ambrisentan) or oral prostanoids (soluble guanylate cyclase stimulators \[riociguat\]), which was ongoing at the time of randomization. Additional PAH-specific therapy other than macitentan and IV or SC prostanoids initiated prior to randomization was continued. Participants received treatment from Day 1 up to 316.4 weeks. For participants with disease progression, crossover to macitentan was offered after confirmation of a disease progression event by the blinded Clinical Event Committee.	Macitentan (JNJ-67896062) (<2 Years) Enrolled participants aged \<2 years received macitentan 2.5 mg once daily orally (dispersible tablet reconstituted in water). Oral or inhaled prostanoid treatment were allowed as PAH-specific background therapy. Participants received treatment from Day 1 up to 72.9 weeks.
Overall Study Death	7	6	0
Overall Study Lost to Follow-up	1	2	0
Overall Study Parent/Subjects decision	6	6	1
Overall Study Physician Decision	0	1	0

Baseline Characteristics

A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Macitentan (JNJ-67896062) (>=2 Years) n=73 Participants Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.	Standard of Care (SoC; >=2 Years) n=75 Participants Randomized participants aged \>=2 years continued their SoC as per site's clinical practice which comprised treatment with the pulmonary arterial hypertension (PAH) non-specific treatment and/or up to 2 PAH-specific medications excluding macitentan and intravenous (IV)/subcutaneous (SC) prostanoids. Participants continued to receive the PDE-5i (sildenafil and tadalafil), or other PAH-specific treatment such as an ERA (bosentan and ambrisentan) or oral prostanoids (soluble guanylate cyclase stimulators \[riociguat\]), which was ongoing at the time of randomization. Additional PAH-specific therapy other than macitentan and IV or SC prostanoids initiated prior to randomization was continued. Participants received treatment from Day 1 up to 316.4 weeks. For participants with disease progression, crossover to macitentan was offered after confirmation of a disease progression event by the blinded Clinical Event Committee.	Macitentan (JNJ-67896062) (<2 Years) n=9 Participants Enrolled participants aged \<2 years received macitentan 2.5 mg once daily orally (dispersible tablet reconstituted in water). Oral or inhaled prostanoid treatment were allowed as PAH-specific background therapy. Participants received treatment from Day 1 up to 72.9 weeks.	China Single-arm Cohort (>=12 to <18 Years) n=8 Participants Enrolled participants aged \>=12 to \<18 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 (PDE-5) inhibitor was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 48.29 weeks.	Total n=165 Participants Total of all reporting groups
Age, Continuous	10.5 years STANDARD_DEVIATION 4.43 • n=10 Participants	9 years STANDARD_DEVIATION 4.32 • n=10 Participants	1.7 years STANDARD_DEVIATION 0.27 • n=20 Participants	12.9 years STANDARD_DEVIATION 1.13 • n=45 Participants	9.4 years STANDARD_DEVIATION 4.65 • n=44 Participants
Age, Customized >= 0 to < 0.5 years	0 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	0 Participants n=44 Participants
Age, Customized >= 0.5 to < 2 years	0 Participants n=10 Participants	0 Participants n=10 Participants	9 Participants n=20 Participants	0 Participants n=45 Participants	9 Participants n=44 Participants
Age, Customized >= 2 to < 6 years	13 Participants n=10 Participants	22 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	35 Participants n=44 Participants
Age, Customized >= 6 to < 12 years	29 Participants n=10 Participants	32 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	61 Participants n=44 Participants
Age, Customized >= 12 to < 18 years	31 Participants n=10 Participants	21 Participants n=10 Participants	0 Participants n=20 Participants	8 Participants n=45 Participants	60 Participants n=44 Participants
Sex: Female, Male Female	50 Participants n=10 Participants	38 Participants n=10 Participants	1 Participants n=20 Participants	4 Participants n=45 Participants	93 Participants n=44 Participants
Sex: Female, Male Male	23 Participants n=10 Participants	37 Participants n=10 Participants	8 Participants n=20 Participants	4 Participants n=45 Participants	72 Participants n=44 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=10 Participants	22 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	48 Participants n=44 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	47 Participants n=10 Participants	51 Participants n=10 Participants	6 Participants n=20 Participants	8 Participants n=45 Participants	112 Participants n=44 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=10 Participants	2 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	5 Participants n=44 Participants
Race/Ethnicity, Customized Asian	15 Participants n=10 Participants	22 Participants n=10 Participants	3 Participants n=20 Participants	8 Participants n=45 Participants	48 Participants n=44 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=10 Participants	1 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	4 Participants n=44 Participants
Race/Ethnicity, Customized White	44 Participants n=10 Participants	32 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	78 Participants n=44 Participants
Race/Ethnicity, Customized Unknown or Not Reported	1 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	3 Participants n=44 Participants
Race/Ethnicity, Customized Other	12 Participants n=10 Participants	18 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	32 Participants n=44 Participants
Region of Enrollment AUSTRALIA	2 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	4 Participants n=44 Participants
Region of Enrollment BRAZIL	1 Participants n=10 Participants	1 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	2 Participants n=44 Participants
Region of Enrollment CHINA	1 Participants n=10 Participants	0 Participants n=10 Participants	0 Participants n=20 Participants	8 Participants n=45 Participants	9 Participants n=44 Participants
Region of Enrollment COLOMBIA	7 Participants n=10 Participants	7 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	14 Participants n=44 Participants
Region of Enrollment FRANCE	1 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	3 Participants n=44 Participants
Region of Enrollment HUNGARY	3 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	5 Participants n=44 Participants
Region of Enrollment ISRAEL	1 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	3 Participants n=44 Participants
Region of Enrollment MALAYSIA	0 Participants n=10 Participants	0 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	1 Participants n=44 Participants
Region of Enrollment MEXICO	15 Participants n=10 Participants	14 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	31 Participants n=44 Participants
Region of Enrollment PHILIPPINES	3 Participants n=10 Participants	4 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	9 Participants n=44 Participants
Region of Enrollment POLAND	2 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	4 Participants n=44 Participants
Region of Enrollment PORTUGAL	3 Participants n=10 Participants	1 Participants n=10 Participants	1 Participants n=20 Participants	0 Participants n=45 Participants	5 Participants n=44 Participants
Region of Enrollment RUSSIAN FEDERATION	7 Participants n=10 Participants	6 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	13 Participants n=44 Participants
Region of Enrollment Korea, Republic of	4 Participants n=10 Participants	3 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	7 Participants n=44 Participants
Region of Enrollment SPAIN	3 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	5 Participants n=44 Participants
Region of Enrollment THAILAND	2 Participants n=10 Participants	2 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	4 Participants n=44 Participants
Region of Enrollment UKRAINE	8 Participants n=10 Participants	7 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	15 Participants n=44 Participants
Region of Enrollment UNITED STATES	6 Participants n=10 Participants	6 Participants n=10 Participants	2 Participants n=20 Participants	0 Participants n=45 Participants	14 Participants n=44 Participants
Region of Enrollment VIETNAM	4 Participants n=10 Participants	13 Participants n=10 Participants	0 Participants n=20 Participants	0 Participants n=45 Participants	17 Participants n=44 Participants

PRIMARY outcome

Timeframe: Pre-dose at Week 12

Population: The Pharmacokinetics (PK) 1 set included all participants aged \>=2 years randomized to and treated with macitentan, for whom a PK blood sample at trough had been taken and who did not deviate from the protocol in a way that affected the evaluation of the PK trough endpoints. Here "N" (Number of participants analyzed) signifies the number of participants that were evaluable for this outcome measure and "n"(number analyzed) signifies number of participants analyzed for specified categories.

Outcome measures

Outcome measures
Measure	Macitentan (JNJ-67896062) (>=2 Years) n=47 Participants Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight Aprocitentan: >=15 kg and <25 kg	859.333 nanograms per milliliter (ng/mL) Standard Deviation 217.2926
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight Aprocitentan: >=25 kg and <50 kg	980.857 nanograms per milliliter (ng/mL) Standard Deviation 391.3308
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight Aprocitentan: >=50 kg	1011.267 nanograms per milliliter (ng/mL) Standard Deviation 288.3632
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight Aprocitentan: >=10 kg to <15 kg	1165.000 nanograms per milliliter (ng/mL) Standard Deviation 390.7628
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight Macitentan: >=10 kg and <15 kg	150.133 nanograms per milliliter (ng/mL) Standard Deviation 67.5742
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight Macitentan: >=15 kg and <25 kg	153.892 nanograms per milliliter (ng/mL) Standard Deviation 108.3185
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight Macitentan: >=25 kg and <50 kg	200.975 nanograms per milliliter (ng/mL) Standard Deviation 151.6511
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Body Weight Macitentan: >=50 kg	208.067 nanograms per milliliter (ng/mL) Standard Deviation 92.4246

PRIMARY outcome

Timeframe: Pre-dose at Week 12

Observed steady-state trough (pre-dose) plasma concentration of macitentan and aprocitentan (active metabolite) at Week 12 based on age group were reported. This outcome measure was planned to be analyzed for specified arms only.

Outcome measures

Outcome measures
Measure	Macitentan (JNJ-67896062) (>=2 Years) n=47 Participants Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group Macitentan: >=2 to <6 years	159.767 nanograms per milliliter (ng/mL) Standard Deviation 84.5424
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group Macitentan: >=6 to <12 years	184.792 nanograms per milliliter (ng/mL) Standard Deviation 148.2530
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group Macitentan: >=12 to <18 years	196.484 nanograms per milliliter (ng/mL) Standard Deviation 88.1549
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group Aprocitentan: >=2 to <6 years	1063.333 nanograms per milliliter (ng/mL) Standard Deviation 376.4173
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group Aprocitentan: >=6 to <12 years	957.211 nanograms per milliliter (ng/mL) Standard Deviation 335.0858
Participants >=2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Based on Age Group Aprocitentan: >=12 to <18 years	970.842 nanograms per milliliter (ng/mL) Standard Deviation 298.5151

PRIMARY outcome

Timeframe: Pre-dose at Week 4

Population: PK Set 3 included all participants aged \<2 years and treated with macitentan for whom a PK blood sample had been taken and who did not deviate from the protocol in a way that might affect the evaluation of the PK endpoints.

Observed steady-state trough (pre-dose) plasma concentration of macitentan and aprocitentan (active metabolite) at Week 4 were reported. This outcome measure was planned to be analyzed for specified arms only.

Outcome measures

Outcome measures
Measure	Macitentan (JNJ-67896062) (>=2 Years) n=9 Participants Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.
Participants <2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 4 Macitentan	101.822 ng/mL Standard Deviation 91.9652
Participants <2 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 4 Aprocitentan	707.089 ng/mL Standard Deviation 465.5760

PRIMARY outcome

Timeframe: Pre-dose at Week 12

Population: PK Analysis Set China (PK CHN) included all participants \>=12 years to \<18 years who were treated with macitentan, for whom a PK blood sample has been taken and who did not deviate from the protocol in a way that might affect the evaluation of the PK endpoints.

Observed steady-state trough (pre-dose) plasma concentration of macitentan and aprocitentan (active metabolite) at Week 12 were reported.

Outcome measures

Outcome measures
Measure	Macitentan (JNJ-67896062) (>=2 Years) n=8 Participants Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.
Participants From China With >=12 to <18 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Aprocitentan	1313.75 ng/mL Standard Deviation 293.644
Participants From China With >=12 to <18 Years of Age: Observed Steady-State Trough (Pre-dose) Plasma Concentration of Macitentan and Aprocitentan (Active Metabolite) at Week 12 Macitentan	201.61 ng/mL Standard Deviation 116.685

Serious events: 26 serious events

Other events: 60 other events

Deaths: 7 deaths

Macitentan (JNJ67896062) (<2 Years)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Standard of Care (SoC; >=2 Years)

Serious events: 21 serious events

Other events: 44 other events

Deaths: 6 deaths

SOC (>=2 Years) Crossover to Macitentan

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

China Single-arm Cohort (>=12 to <18 Years)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Macitentan (JNJ-67896062) (>=2 Years) n=72 participants at risk Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.	Macitentan (JNJ67896062) (<2 Years) n=9 participants at risk Enrolled participants aged \<2 years received macitentan 2.5 mg once daily orally (dispersible tablet reconstituted in water). Oral or inhaled prostanoid treatment were allowed as PAH-specific background therapy. Participants received treatment from Day 1 up to 72.9 weeks.	Standard of Care (SoC; >=2 Years) n=75 participants at risk Randomized participants aged \>=2 years continued their SoC as per site's clinical practice which comprised treatment with the pulmonary arterial hypertension (PAH) non-specific treatment and/or up to 2 PAH-specific medications excluding macitentan and intravenous (IV)/subcutaneous (SC) prostanoids. Participants continued to receive the PDE-5i (sildenafil and tadalafil), or other PAH-specific treatment such as an ERA (bosentan and ambrisentan) or oral prostanoids (soluble guanylate cyclase stimulators \[riociguat\]), which was ongoing at the time of randomization. Additional PAH-specific therapy other than macitentan and IV or SC prostanoids initiated prior to randomization was continued. Participants received treatment from Day 1 up to 316.4 weeks. For participants with disease progression, crossover to macitentan was offered after confirmation of a disease progression event by the blinded Clinical Event Committee.	SOC (>=2 Years) Crossover to Macitentan n=8 participants at risk Participants aged \>=2 years randomized to SoC arm and who had Clinical Event Committee-confirmed disease progression were offered to cross-over to macintentan treatment by signing a separate informed consent, if they agreed per investigator judgment. Eligible participants received macitentan orally (dispersible tablet reconstituted in water) once daily based on their BW: 3.5 mg for BW \>=10 kg and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Participants received treatment from Day of disease confirmation up to 107 weeks.	China Single-arm Cohort (>=12 to <18 Years) n=8 participants at risk Enrolled participants aged \>=12 to \<18 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 (PDE-5) inhibitor was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 48.29 weeks.
Blood and lymphatic system disorders Anaemia	2.8% 2/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Blood and lymphatic system disorders Antiphospholipid Syndrome	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Cardiac disorders Cardiac Arrest	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Cardiac disorders Cardiogenic Shock	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Cardiac disorders Pericarditis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Cardiac disorders Right Ventricular Failure	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Cardiac disorders Sinus Tachycardia	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Cardiac disorders Supraventricular Tachycardia	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Congenital, familial and genetic disorders Atrial Septal Defect	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Gastrointestinal disorders Abdominal Pain	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Gastrointestinal disorders Constipation	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Gastrointestinal disorders Gastritis	2.8% 2/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Gastrointestinal disorders Haematemesis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Asthenia	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Influenza Like Illness	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Non-Cardiac Chest Pain	2.8% 2/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Cellulitis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Covid-19	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Dengue Fever	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Febrile Infection	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Gastroenteritis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Gastroenteritis Viral	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Influenza	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Laryngitis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Lower Respiratory Tract Infection	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Mediastinitis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Pneumonia	6.9% 5/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	22.2% 2/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Pneumonia Mycoplasmal	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Respiratory Syncytial Virus Bronchiolitis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Respiratory Tract Infection	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Respiratory Tract Infection Viral	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Salmonella Bacteraemia	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Salpingo-Oophoritis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Tonsillitis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Upper Respiratory Tract Infection	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Urinary Tract Infection	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Viral Infection	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Wound Infection	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Injury, poisoning and procedural complications Concussion	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Injury, poisoning and procedural complications Overdose	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Injury, poisoning and procedural complications Thermal Burn	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Investigations Alanine Aminotransferase Increased	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Investigations Oxygen Saturation Decreased	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Musculoskeletal and connective tissue disorders Camptodactyly Acquired	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Musculoskeletal and connective tissue disorders Costochondritis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Musculoskeletal and connective tissue disorders Systemic Scleroderma	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Nervous system disorders Brain Oedema	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Nervous system disorders Dizziness	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Nervous system disorders Headache	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Nervous system disorders Hypoxic-Ischaemic Encephalopathy	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Nervous system disorders Status Epilepticus	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Psychiatric disorders Depression	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Renal and urinary disorders Acute Kidney Injury	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Renal and urinary disorders Urethral Stenosis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Reproductive system and breast disorders Heavy Menstrual Bleeding	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Reproductive system and breast disorders Uterine Haemorrhage	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Asthma	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Asthmatic Crisis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Bronchospasm	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Haemoptysis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Laryngeal Stenosis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Pleural Effusion	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Pulmonary Arterial Hypertension	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Respiratory Failure	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Systemic Sclerosis Pulmonary	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Skin and subcutaneous tissue disorders Dermatomyositis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Skin and subcutaneous tissue disorders Rash	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Surgical and medical procedures Hospitalisation	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Vascular disorders Extremity Necrosis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Vascular disorders Hypotension	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Vascular disorders Thrombosis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)

Other adverse events

Other adverse events
Measure	Macitentan (JNJ-67896062) (>=2 Years) n=72 participants at risk Randomized participants aged \>=2 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg, and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 inhibitor (PDE-5i) was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 312.4 weeks.	Macitentan (JNJ67896062) (<2 Years) n=9 participants at risk Enrolled participants aged \<2 years received macitentan 2.5 mg once daily orally (dispersible tablet reconstituted in water). Oral or inhaled prostanoid treatment were allowed as PAH-specific background therapy. Participants received treatment from Day 1 up to 72.9 weeks.	Standard of Care (SoC; >=2 Years) n=75 participants at risk Randomized participants aged \>=2 years continued their SoC as per site's clinical practice which comprised treatment with the pulmonary arterial hypertension (PAH) non-specific treatment and/or up to 2 PAH-specific medications excluding macitentan and intravenous (IV)/subcutaneous (SC) prostanoids. Participants continued to receive the PDE-5i (sildenafil and tadalafil), or other PAH-specific treatment such as an ERA (bosentan and ambrisentan) or oral prostanoids (soluble guanylate cyclase stimulators \[riociguat\]), which was ongoing at the time of randomization. Additional PAH-specific therapy other than macitentan and IV or SC prostanoids initiated prior to randomization was continued. Participants received treatment from Day 1 up to 316.4 weeks. For participants with disease progression, crossover to macitentan was offered after confirmation of a disease progression event by the blinded Clinical Event Committee.	SOC (>=2 Years) Crossover to Macitentan n=8 participants at risk Participants aged \>=2 years randomized to SoC arm and who had Clinical Event Committee-confirmed disease progression were offered to cross-over to macintentan treatment by signing a separate informed consent, if they agreed per investigator judgment. Eligible participants received macitentan orally (dispersible tablet reconstituted in water) once daily based on their BW: 3.5 mg for BW \>=10 kg and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Participants received treatment from Day of disease confirmation up to 107 weeks.	China Single-arm Cohort (>=12 to <18 Years) n=8 participants at risk Enrolled participants aged \>=12 to \<18 years received macitentan orally (dispersible tablet reconstituted in water) once daily based on their body weight (BW): 3.5 milligrams (mg) for BW \>=10 kilograms (kg) and \<15 kg, 5.0 mg for \>=15 kg and \<25 kg, 7.5 mg for \>=25 kg and \<50 kg and 10.0 mg for \>=50 kg. Every 12 weeks body weight was checked for potential dose adjustment. Phosphodiesterase Type 5 (PDE-5) inhibitor was the only allowed PAH-specific background medication until disease progression. Participants received treatment from Day 1 up to 48.29 weeks.
Blood and lymphatic system disorders Anaemia	8.3% 6/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	4.0% 3/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Gastrointestinal disorders Abdominal Pain	5.6% 4/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	8.0% 6/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Gastrointestinal disorders Constipation	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Gastrointestinal disorders Diarrhoea	9.7% 7/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	8.0% 6/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Gastrointestinal disorders Vomiting	6.9% 5/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	10.7% 8/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Fatigue	6.9% 5/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Feeling Abnormal	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Influenza Like Illness	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Non-Cardiac Chest Pain	5.6% 4/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	5.3% 4/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Oedema Peripheral	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
General disorders Pyrexia	9.7% 7/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	4.0% 3/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Bronchitis	6.9% 5/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	10.7% 8/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Cellulitis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Conjunctivitis	2.8% 2/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Covid-19	15.3% 11/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	22.2% 2/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	8.0% 6/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Gastroenteritis	12.5% 9/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	22.2% 2/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Influenza	11.1% 8/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	5.3% 4/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Nasopharyngitis	19.4% 14/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	16.0% 12/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Otitis Media Acute	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Parotitis	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Pharyngitis	6.9% 5/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	8.0% 6/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Pharyngotonsillitis	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Pneumonia	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Respiratory Tract Infection	5.6% 4/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Rhinitis	8.3% 6/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	4.0% 3/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Suspected Covid-19	1.4% 1/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Tonsillitis	5.6% 4/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Upper Respiratory Tract Infection	30.6% 22/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	44.4% 4/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	17.3% 13/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Urinary Tract Infection	4.2% 3/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	4.0% 3/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Varicella	2.8% 2/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Infections and infestations Viral Upper Respiratory Tract Infection	4.2% 3/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	4.0% 3/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Injury, poisoning and procedural complications Limb Injury	2.8% 2/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Injury, poisoning and procedural complications Skin Abrasion	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Investigations Haemoglobin Decreased	5.6% 4/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Investigations Anticoagulation Drug Level Increased	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Investigations N-Terminal Prohormone Brain Natriuretic Peptide Increased	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Investigations Weight Increased	2.8% 2/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Metabolism and nutrition disorders Iron Deficiency	2.8% 2/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	4.0% 3/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lipoma	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Nervous system disorders Dizziness	8.3% 6/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Nervous system disorders Headache	19.4% 14/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.0% 9/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Reproductive system and breast disorders Amenorrhoea	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Reproductive system and breast disorders Polymenorrhoea	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Cough	9.7% 7/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	6.7% 5/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Epistaxis	6.9% 5/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.0% 9/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	25.0% 2/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Nasal Congestion	9.7% 7/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	8.3% 6/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	5.3% 4/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Respiratory, thoracic and mediastinal disorders Rhinitis Allergic	5.6% 4/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	11.1% 1/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	2.7% 2/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)
Vascular disorders Haematoma	0.00% 0/72 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/9 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	1.3% 1/75 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	12.5% 1/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)	0.00% 0/8 • All cause mortality: From screening (-6 weeks) up to 7.26 years; SAEs and Non-SAEs: Baseline (Day 1) up to end of core study period (EOCP; up to 7.08 years) All-cause mortality: FAS3 participants (FAS1 + FAS2) + FAS CHN participants (aged \>= 12 years, assigned to macitentan without randomization). SAEs and other AEs: SAS3 (SAS1 + SAS2) + Safety CHN participants (aged \>= 12 years, received at least 1 dose of macitentan)

Additional Information

Executive Medical Director CP

Actelion Pharmaceuticals Ltd

Phone: 844-434-4210

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the Sponsor for review at least 60 days before submission for publication or presentation. If requested by the Sponsor in writing, the investigator will withhold such publication for up to an additional 60 days to allow for filing of a patent application.
Publication restrictions are in place

Restriction type: OTHER