| Primary | Number of Participants With All-cause Deaths up to 30 Days After Study Treatment Discontinuation | Number of participants with all-cause deaths up to 30 days after study treatment discontinuation were reported. All-cause deaths are defined as all anticipated and unanticipated deaths due to any cause. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 milligrams (mg). | Posted | | Count of Participants | | Participants | | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks) | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Number of Participants With All-cause Hospital Admissions up to 30 Days After Study Treatment Discontinuation | Number of participants with all-cause hospital admissions up to 30 days after study treatment discontinuation were reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. | Posted | | Count of Participants | | Participants | | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks) | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) up to 30 Days After Study Treatment Discontinuation | 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 a suspected transmission of any infectious agent via a medicinal product, 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 AE and SAE occurring at or after the study treatment start up to 30 days after end of treatment (EOT) within the analysis set was considered to be treatment-emergent. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. | Posted | | Count of Participants | | Participants | | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks) | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | 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 within the analysis set was considered to be treatment-emergent. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. | Posted | | Count of Participants | | Participants | | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks) | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP) at Week 24 | Change from baseline in systolic and diastolic arterial BP at Week 24 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | millimeters of mercury (mmHg) | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Systolic and Diastolic Arterial Blood Pressure (BP) at Week 52 | Change from baseline in systolic and diastolic arterial BP at Week 52 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mmHg | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Pulse Rate at Week 24 | Change from baseline in pulse rate at Week 24 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | beats per minute (bpm) | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Pulse Rate at Week 52 | Change from baseline in pulse rate at Week 52 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | bpm | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Body Weight at Week 24 | Change from baseline in body weight at Week 24 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | kilograms (kg) | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Body Weight at Week 52 | Change from baseline in body weight at Week 52 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | kg | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Number of Participants With Treatment-emergent Marked Laboratory Abnormalities (MLAs) up to 30 Days After Study Treatment Discontinuation | Number of participants with treatment-emergent MLAs (Hemoglobin [grams/Liter{L}], Hematocrit [L/L], Leukocytes [10^9cells/L], Lymphocytes [10^9cells/L], Alanine Aminotransferase [Units/L {U/L}], Aspartate Aminotransferase [U/L], Bilirubin [micromoles/L {mcmol/L}], Alkaline Phosphatase [U/L], Creatinine [mcmol/L], Urea Nitrogen [mmol/L], Urate [mcmol/L], Potassium [mmol/L], Sodium [mmol/L], Magnesium [mmol/L], Calcium [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. Here, > signifies greater than; < signifies less than; ULN signifies upper limit of normal; and L=Low, H=High, LL=low/low, HH=high/high, LLL=lower/worse than LL, HHH=higher/worse than HH. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Up to 30 days after study treatment discontinuation (treatment exposure ranged from 0.4 to 126 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Hemoglobin at Week 24 | Change from baseline in hemoglobin at Week 24 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | grams per liter (g/L) | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Hemoglobin at Week 52 | Change from baseline in hemoglobin at Week 52 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | grams per litre (g/L) | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Leukocytes and Platelets at Week 24 | Change from baseline in leukocytes and platelets at Week 24 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Leukocytes and Platelets at Week 52 | Change from baseline in leukocytes and platelets at Week 52 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Alanine Aminotransferase and Aspartate Aminotransferase at Week 24 | Change from baseline in alanine aminotransferase and aspartate aminotransferase at Week 24 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure; "n" specifies those participants who were analyzed for specific category. | Posted | | Mean | Standard Deviation | units per liter (U/L) | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Alanine Aminotransferase and Aspartate Aminotransferase at Week 52 | Change from baseline in alanine aminotransferase and aspartate aminotransferase at Week 52 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | U/L | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Bilirubin at Week 24 | Change from baseline in bilirubin at Week 24 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | micromoles per liter (mcmol/L) | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Bilirubin at Week 52 | Change from baseline in bilirubin at Week 52 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | mcmol/L | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 24 | Change from baseline in eGFR rate at Week 24 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | milliliters/minute/1.73 meter square | | Baseline and Week 24 | | | | ID | Title | Description |
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| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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| Primary | Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 | Change from baseline in eGFR rate at Week 52 was reported. | The safety analysis set included all participants who received at least 1 dose of macitentan 10 mg. Here, "N" (number of participants analyzed) specifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | milliliters/minute/1.73 meter square | | Baseline and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | Macitentan 10 mg | Eligible participants who remained in the main study (NCT03153111) for at least 24 weeks after randomization, entered this open-label extension study to receive macitentan 10 milligrams (mg) tablet orally once daily until the end of the treatment (treatment exposure ranged from 0.4 to 126 weeks). |
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