| Primary | Change of Pulmonary Vascular Resistance (PVR) | Change in pulmonary hemodynamics assessed by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | WU | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-0.69± 0.60
- OG0010.89± 3.29
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | baseline value as covariate | 0.043 | | | | | | | | | | | | | | Superiority | | | | | Multiple imputation | | 0.045 |
|
| Secondary | Change of Cardiac Index (CI) at Rest From Baseline at 24 Weeks | Change in pulmonary hemodynamics assessed by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | l/min/m2 | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Secondary | Change of Total Pulmonary Resistance (TPR) From Baseline at 24 Weeks | Change in Pulmonary hemodynamics assessed by right heart catheterization Hierarchical testing of secondary endpoints stopped after first step. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg·min/L | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Secondary | Change of Diffusion Capacity of the Lung (DLCO) From Baseline at 24 Weeks | Change assessed by lung function tests. Hierarchical testing of secondary endpoints stopped after first step. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | percent predicted | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Secondary | Change in 6-minute Walking Distance (6MWD) | Change in exercise capacity assessed by 6-minute walking distance test Hierarchical testing of secondary endpoints stopped after first step. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | m | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Secondary | Change of World Health Organization- Functional Class (WHO-FC) From Baseline at 24 Weeks | Change of WHO functional class, change score The World Health Organization (WHO) functional class (FC) describes the severity of pulmonary hypertension (PH) symptoms. FC I is considered the mildest and FC IV the most severe form of PH. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Count of Participants | | Participants | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change of World Health Organization- Functional Class (WHO-FC) From Baseline at 12 Weeks | Change of WHO functional class, change score The World Health Organization (WHO) functional class (FC) describes the severity of pulmonary hypertension (PH) symptoms. FC I is considered the mildest and FC IV the most severe form of PH. | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. | Posted | | Count of Participants | | Participants | | baseline, 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Quality of Life (QoL) From Baseline at 24 Weeks | Quality of Life (QoL) was assessed using the Short Form (SF) 36-questionnaire. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale, i.e. a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability. Sections: vitality; physical functioning; bodily pain; general health perceptions; physical role functioning; emotional role functioning; social role functioning; mental health. Two summation scores, physical and mental summation score, were calculated | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | scores on a scale | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo |
|
| Other Pre-specified | Change in Forced Expiratory Volume in 1 Second (FEV1) From Baseline at 24 Weeks | Lung function and lung diffusing capacity | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | percent predicted | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Total Lung Capacity (TLC) From Baseline at 24 Weeks | Lung function and lung diffusing capacity | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | percent predicted | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Diffusing Capacity of the Lung (DLCO) | Lung function and lung diffusing capacity | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | percent predicted | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Systolic Pulmonary Arterial Pressure (sPAP) From Baseline at 24 Weeks | Change in systolic pulmonary arterial pressure (sPAP) from baseline at 24 weeks assessed by echocardiography | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Right Ventricular Area (RV-area) From Baseline at 24 Weeks | Change in right ventricular area (RV-area) from baseline at 24 weeks assessed by echocardiography | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | cm2 | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Right Atrial Area (RA-area) From Baseline at 24 Weeks | Change in right atrial area (RA-area) from baseline at 24 weeks assessed by echocardiography | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | cm2 | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) From Baseline at 24 Weeks | Change in tricuspid annular plane systolic excursion (TAPSE) from baseline at 24 weeks assessed by echocardiography | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | cm | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Left Ventricular Eccentricity Index (LV-EI) From Baseline at 24 Weeks | Change in left ventricular eccentricity index (LV-EI) from baseline at 24 weeks assessed by echocardiography. LV-EI is the ratio of septical-parallel to septical-perdendicular left ventricular diameters in parasternal short-axis view; normal = 1, increased (≥ 1.1) indicates right ventricular pressure/volume overload | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | index | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
|
| Other Pre-specified | Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-pro BNP) From Baseline at 12 Weeks | | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | pg/ml | | baseline, 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in N-terminal Prohormone of Brain Natriuretic Peptide (NT-pro BNP) From Baseline at 24 Weeks | | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | pg/ml | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Oxygen Partial Pressure (PaO2) From Baseline at 24 Weeks | Change in oxygen partial pressure (PaO2) from baseline at 24 weeks assessed by blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily) The dose was individually adjusted in accordance with the in-label titration regimen based on the systemic blood pressure of the patient, the subjects and physicians' subjective estimation and occurrence of adverse reactions. At week 8, the maintenance dose was established and continued for the rest of the study treatment phase | | OG001 | Placebo | Placebo oral tablet matching riociguat: Sham titration and adjustment to maintenance dose according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Carbon Dioxide Partial Pressure (PCO2) | | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change Oxygen Saturation of the Blood (SaO2) | Change oxygen saturation of the blood (SaO2) assessed by blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | percent SaO2 | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in pH | | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | pH | | baseline,24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Bicarbonates | | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. | Posted | | Mean | Standard Deviation | mmol/L | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Base Excess | Change in base excess assessed by blood gas analysis | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmol/L | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Systolic Pulmonary Arterial Pressure (sPAP) | Pulmonary hemodynamics assessed by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in Mean Pulmonary Arterial Pressure (mPAP) | Pulmonary hemodynamics assessed by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in dPAP (Diastolic Pulmonary Artery Pressure) | Pulmonary hemodynamics assessed by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in PAWP (Pulmonary Artery Wedge Pressure) | Pulmonary hemodynamics assessed by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg | | baseline, 24 weeks | | | | ID | Title | Description |
|---|
| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
| |
| Other Pre-specified | Change in RAP (Right Atrial Pressure) | Pulmonary hemodynamics assessed by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | mmHg | | baseline, 24 weeks | | | | ID | Title | Description |
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| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
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| Other Pre-specified | Change in Cardiac Output and Ejection Fraction (CO) | Pulmonary hemodynamics assessed by right heart catheterization | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | L/min | | baseline, 24 weeks | | | | ID | Title | Description |
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| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
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| Other Pre-specified | Change in Central Venous Saturation (SvO2) | | All randomized participants were included in the analysis (intention-to-treat population). The number of analyzed paticipants may vary due to missing data for specific outcome measures. The per-protocol set is identical to the intention-to-treat set, as no major protocol deviations occurred and all participants met the predefined eligibility criteria. | Posted | | Mean | Standard Deviation | percent SvO2 | | baseline, 24 weeks | | | | ID | Title | Description |
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| OG000 | Riociguat | Riociguat Oral Tablet: Riociguat Oral Tablet (1 mg, 1.5 mg, 2.0 mg or 2.5 mg three times daily): individually adjusted dose in accordance with the in-label titration regimen (maximum dosage of 2.5mg tid). At week 8, the maintenance dose was established and maintained for the rest of study participation. | | OG001 | Placebo | Placebo oral tablets: Sham titration and adjustment to maintenance dose (tid) according to individual tolerability as in the experimental arm. |
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