An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after end of treatment (EOT) (limits included) within the analysis set was considered to be treatment-emergent.

The RUBATO open-label extension set (OLES) included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 milligrams (mg).

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Any SAE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be TESAEs.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg.

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be treatment-emergent.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg.

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. Any AE occurring at or after the study treatment start up to 30 days after EOT (limits included) within the analysis set was considered to be treatment-emergent.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg.

Number of participants with treatment-emergent marked laboratory abnormalities (Hemoglobin [gram/Liter {g/L}], Platelets [giga/L {10^9 cells/L}], Leukocytes [10^9 cells/L], Lymphocytes [10^9 cells/L], Neutrophils [10^9 cells/L], Prothrombin International Normalized Ratio [PINR;Ratio], Aspartate Aminotransferase [Units/L {U/L}], Bilirubin [micromoles/L {mcmol/L}], Alkaline Phosphatase [U/L], Glomerular Filtration Rate [milliliter/minute/1.73 meter square], Glucose [millimoles/L {mmol/L}], Potassium [mmol/L], Sodium [mmol/L], Triglycerides [mmol/L] were reported. Abnormalities that occurred after study treatment start and up to 30 days after study treatment discontinuation, that were not present at baseline, were treatment-emergent. Marked laboratory abnormalities reported for at least 1 participant were reported in this outcome measure. >=:greater than or equal to; >:greater than; <:less than; ULN: upper limit of normal; L:Low, H:High, LLL:lower/worse than LL, HHH:higher/worse than HH.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "n" specifies those participants who were analyzed for each specific category.

Change from baseline in hemoglobin over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (overall number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in hematocrit over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in leukocytes, neutrophils, lymphocytes, and platelets over time were reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in systolic and diastolic arterial BP over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in pulse rate over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in SpO2 over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in body weight over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in ALT, AST, AP, and GGT over time were reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in bilirubin, direct bilirubin, and creatinine over time were reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in GFR over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in prothrombin time over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in prothrombin international normalized ratio over time was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in peak VO2 was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.

Change from baseline in mean count per minute of daily PA-Ac was reported in this outcome measure.

The RUBATO OLES included all participants who were enrolled in this study and received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure and; "n" specifies those participants who were analyzed at specified timepoints.