An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

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.

Time frame: Up to 133 weeks

Number of Participants With Treatment-emergent Serious AEs (TESAEs)

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.

Time frame: Up to 133 weeks

Number of Participants With TEAEs Leading to Death

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.

Time frame: Up to 133 weeks

Number of Participants With TEAEs Leading to Premature Discontinuation of Study Treatment

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.

Time frame: Up to 133 weeks

Number of Participants With Treatment-emergent Marked Laboratory Abnormalities up to 30 Days After Study Treatment Discontinuation

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.

Time frame: Up to 133 weeks

Change From Baseline in Hemoglobin Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Hematocrit Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Leukocytes, Neutrophils, Lymphocytes, and Platelets Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP) Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Pulse Rate Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Peripheral Oxygen Saturation (SpO2) Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Body Weight Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (AP), and Gamma Glutamyl Transferase (GGT) Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Bilirubin, Direct Bilirubin, and Creatinine Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Glomerular Filtration Rate (GFR) Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Prothrombin Time Over Time

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

Time frame: Baseline up to Week 130

Change From Baseline in Prothrombin International Normalized Ratio Over Time

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

Time frame: Baseline up to Week 130