Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT02562235
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-03
First Post:
2015-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Brazil', 'France', 'Netherlands', 'Romania', 'Spain', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C542595', 'term': 'riociguat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayer.com', 'phone': '1-888-8422937', 'title': 'Therapeutic Area Head', 'organization': 'Bayer'}, 'certainAgreement': {'otherDetails': 'Most restricted agreement: CTA Japan; Embargo time mentioned. Hospital shall obtain prior written consent of Sponsor if PI intends to publish the information obtained from study externally such as in a professional society or association.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The results should be interpreted with caution due to the limited number of subjects. The number of subjects with clinical worsening events was too low to produce valid Kaplan-Meier estimates for the time to clinical worsening.'}}, 'adverseEventsModule': {'timeFrame': 'From start of study drug up to 2 days after the last dose of study drug in the main study part, up to 24 weeks plus/minus 5 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 15, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 7, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 11, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'seriousEvents': [{'term': 'Pain of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Skin swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Any Treatment-emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Any TEAE', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}]}]}, {'title': 'Any serious TEAE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study drug up to 2 days after the last dose of study drug in the main study part, up to 24 weeks plus/minus 5 days.', 'description': 'An adverse event (AE), including AE in relation to a medical device (i.e. Raumedic dosing pipette), is any untoward medical occurrence in a participant administered with a pharmaceutical product and does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is any untoward medical occurrence that at any dose is resulting in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity. AEs occurring between start of study drug and up to 2 days after the last dose were defined as treatment-emergent AEs (TEAEs).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set (SAF)'}, {'type': 'PRIMARY', 'title': 'Change in Heart Rate From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '10.1', 'groupId': 'OG000', 'lowerLimit': '10.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Mean change in heart rate from baseline is reported.', 'unitOfMeasure': 'Beats per minute (BPM)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Blood Pressure From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'SBP', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '10.5', 'groupId': 'OG000', 'lowerLimit': '10.5'}]}]}, {'title': 'DBP', 'categories': [{'measurements': [{'value': '-2.4', 'spread': '10.0', 'groupId': 'OG000', 'lowerLimit': '10.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Mean changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline are reported.', 'unitOfMeasure': 'millimetre of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Respiratory Rate From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Mean change in respiratory rate from baseline is reported.', 'unitOfMeasure': 'Breath per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Transitions From Baseline in Bone Age Compared to Chronological Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Transitioned from Delayed to In Accordance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transitioned from Delayed to Advanced', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transitioned from In Accordance to Delayed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Transitioned from In Accordance to Advanced', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Transitioned from In Accordance to Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Transitioned from Advanced to Delayed', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Transitioned from Advanced to In Accordance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'X-ray of left hand was performed for each participant and bone age was determined centrally by a specialist. For each participant, the bone age was compared to the chronological age and assigned to one of the categories - "delayed", "in accordance" or "advanced", indicating the advancement or delay in the growth of the bone. Number of participants who transitioned to another category different from baseline was calculated and is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Hematology Parameters (Platelets) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.4', 'spread': '51.1', 'groupId': 'OG000', 'lowerLimit': '51.1'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Hematology parameters were collected. Parameters with a decrease or increase in the mean value compared to baseline are reported in this data set.', 'unitOfMeasure': 'Giga platelets per Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Hematology Parameters (Lymphocytes/Leucocytes Ratio) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.77', 'spread': '11.08', 'groupId': 'OG000', 'lowerLimit': '11.08'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Hematology parameters were collected. Parameters with a decrease or increase in the mean value compared to baseline are reported in this data set.', 'unitOfMeasure': 'Percentage of leucocytes in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Hematology Parameter (Neutrophils/Leucocytes Ratio) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.71', 'spread': '11.73', 'groupId': 'OG000', 'lowerLimit': '11.73'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Hematology parameters were collected. Parameters with a decrease or increase in the mean value compared to baseline are reported in this data set.', 'unitOfMeasure': 'Percentage of leucocytes in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Clinical Chemistry (Alanine Aminotransferase) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.01', 'spread': '9.86', 'groupId': 'OG000', 'lowerLimit': '9.86'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Clinical Chemistry (Aspartate Aminotransferase) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.94', 'spread': '6.52', 'groupId': 'OG000', 'lowerLimit': '6.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Clinical Chemistry (Sodium) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.', 'unitOfMeasure': 'millimole per Liter (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Clinical Chemistry (Blood Urea Nitrogen) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'spread': '4.3', 'groupId': 'OG000', 'lowerLimit': '4.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.', 'unitOfMeasure': 'microgram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Clinical Chemistry (eGFR) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.459', 'spread': '25.686', 'groupId': 'OG000', 'lowerLimit': '25.686'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set. eGFR = estimated glomerular filtration rate', 'unitOfMeasure': 'milliliter/minute/1.73 square meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Clinical Chemistry (Urea) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.06', 'spread': '10.52', 'groupId': 'OG000', 'lowerLimit': '10.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.', 'unitOfMeasure': 'microgram per deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Change in Clinical Chemistry (Gamma Glutamyl Transferase) From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '4.0', 'groupId': 'OG000', 'lowerLimit': '4.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Riociguat at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat 1.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 1.0 mg or body weight-adjusted dose equivalent to the exposure of 1.0 mg dose in adults at the day of PK measurement'}], 'classes': [{'title': 'W0 (30-90 min post-dose)', 'categories': [{'measurements': [{'value': '15.340', 'spread': '90.536', 'groupId': 'OG000'}]}]}, {'title': 'W0 (2.5-4 h post-dose)', 'categories': [{'measurements': [{'value': '17.791', 'spread': '55.690', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0 (30-90 minutes post-dose; 2.5-4 hours post-dose)', 'description': 'For each participant, one blood sample was collected at one given time point. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported. W = Week.', 'unitOfMeasure': 'microgram per liter (mcg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Riociguat at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat 0.5 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 0.5 mg or body weight-adjusted dose equivalent to the exposure of 0.5 mg dose in adults at the day of PK measurement'}, {'id': 'OG001', 'title': 'Riociguat 1.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 1.0 mg or body weight-adjusted dose equivalent to the exposure of 1.0 mg dose in adults at the day of PK measurement'}, {'id': 'OG002', 'title': 'Riociguat 2.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 2.0 mg or body weight-adjusted dose equivalent to the exposure of 2.0 mg dose in adults at the day of PK measurement'}], 'classes': [{'categories': [{'measurements': [{'value': '4.510', 'spread': 'NA', 'comment': 'Value was not calculated due to very low number of participants.', 'groupId': 'OG000'}, {'value': '65.585', 'spread': '47.727', 'groupId': 'OG001'}, {'value': '31.126', 'spread': '89.790', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 (pre-dose)', 'description': 'For each participant, one blood sample was collected at one given time point. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported.', 'unitOfMeasure': 'microgram per liter (mcg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Riociguat at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat 0.5 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 0.5 mg or body weight-adjusted dose equivalent to the exposure of 0.5 mg dose in adults at the day of PK measurement'}, {'id': 'OG001', 'title': 'Riociguat 1.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 1.0 mg or body weight-adjusted dose equivalent to the exposure of 1.0 mg dose in adults at the day of PK measurement'}, {'id': 'OG002', 'title': 'Riociguat 2.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 2.0 mg or body weight-adjusted dose equivalent to the exposure of 2.0 mg dose in adults at the day of PK measurement'}, {'id': 'OG003', 'title': 'Riociguat 2.5 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 2.5 mg or body weight-adjusted dose equivalent to the exposure of 2.5 mg dose in adults at the day of PK measurement'}], 'classes': [{'categories': [{'measurements': [{'value': '11.650', 'spread': '244.238', 'groupId': 'OG000'}, {'value': '27.100', 'spread': 'NA', 'comment': 'Value was not calculated due to very low number of participants.', 'groupId': 'OG001'}, {'value': '14.000', 'spread': 'NA', 'comment': 'Value was not calculated due to very low number of participants.', 'groupId': 'OG002'}, {'value': '32.381', 'spread': '137.719', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 8 (pre-dose)', 'description': 'For each participant, one blood sample was collected at one given time point. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported.', 'unitOfMeasure': 'microgram per liter (mcg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of BAY60-4552 at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat 1.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 1.0 mg or body weight-adjusted dose equivalent to the exposure of 1.0 mg dose in adults at the day of PK measurement'}], 'classes': [{'title': 'W0 (30-90 min post-dose)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Value was not calculated due to very low number of participants.', 'groupId': 'OG000'}]}]}, {'title': 'W0 (2.5-4 h post-dose)', 'categories': [{'measurements': [{'value': '3.922', 'spread': '94.399', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 0 (30-90 minutes post-dose; 2.5-4 hours post-dose)', 'description': "BAY60-4552 is riociguat's active metabolite. For each participant, one blood sample was collected at one given time point and in that sample both riociguat and BAY60-4552 were measured. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported. W = Week", 'unitOfMeasure': 'microgram per liter (mcg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of BAY60-4552 at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat 0.5 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 0.5 mg or body weight-adjusted dose equivalent to the exposure of 0.5 mg dose in adults at the day of PK measurement'}, {'id': 'OG001', 'title': 'Riociguat 1.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 1.0 mg or body weight-adjusted dose equivalent to the exposure of 1.0 mg dose in adults at the day of PK measurement'}, {'id': 'OG002', 'title': 'Riociguat 2.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 2.0 mg or body weight-adjusted dose equivalent to the exposure of 2.0 mg dose in adults at the day of PK measurement'}], 'classes': [{'categories': [{'measurements': [{'value': '12.700', 'spread': 'NA', 'comment': 'Value was not calculated due to very low number of participants.', 'groupId': 'OG000'}, {'value': '48.822', 'spread': '193.584', 'groupId': 'OG001'}, {'value': '38.579', 'spread': '27.242', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 4 (pre-dose)', 'description': "BAY60-4552 is riociguat's active metabolite. For each participant, one blood sample was collected at one given time point and in that sample both riociguat and BAY60-4552 were measured. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported.", 'unitOfMeasure': 'microgram per liter (mcg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of BAY60-4552 at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat 0.5 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 0.5 mg or body weight-adjusted dose equivalent to the exposure of 0.5 mg dose in adults at the day of PK measurement'}, {'id': 'OG001', 'title': 'Riociguat 1.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 1.0 mg or body weight-adjusted dose equivalent to the exposure of 1.0 mg dose in adults at the day of PK measurement'}, {'id': 'OG002', 'title': 'Riociguat 2.0 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 2.0 mg or body weight-adjusted dose equivalent to the exposure of 2.0 mg dose in adults at the day of PK measurement'}, {'id': 'OG003', 'title': 'Riociguat 2.5 mg or Equivalent - PK', 'description': 'Participants who received riociguat at 2.5 mg or body weight-adjusted dose equivalent to the exposure of 2.5 mg dose in adults at the day of PK measurement'}], 'classes': [{'categories': [{'measurements': [{'value': '23.065', 'spread': '91.296', 'groupId': 'OG000'}, {'value': '13.200', 'spread': 'NA', 'comment': 'Value was not calculated due to very low number of participants.', 'groupId': 'OG001'}, {'value': '49.600', 'spread': 'NA', 'comment': 'Value was not calculated due to very low number of participants.', 'groupId': 'OG002'}, {'value': '65.849', 'spread': '26.864', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 8 (pre-dose)', 'description': "BAY60-4552 is riociguat's active metabolite. For each participant, one blood sample was collected at one given time point and in that sample both riociguat and BAY60-4552 were measured. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported.", 'unitOfMeasure': 'microgram per liter (mcg/L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in 6-minute Walking Distance From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.01', 'spread': '68.80', 'groupId': 'OG000', 'lowerLimit': '68.80'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': '6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility.', 'unitOfMeasure': 'Meter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Change in WHO Functional Class From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'title': '-3 classes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '-2 classes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '-1 classes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '0 classes', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': '1 classes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '2 classes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': '3 classes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': "The World Health Organization (WHO) functional class describes how severe a patient's pulmonary hypertension (PH) symptoms are. There are four different classes - I is the mildest and IV the most severe form of PH. Number of participants per change in number of classes is reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in NT-proBNP From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-65.77', 'spread': '585.41', 'groupId': 'OG000', 'lowerLimit': '585.41'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were tested for the participants. When both tests were available, NT-proBNP was chosen over BNP and the same test was performed at every required visit.', 'unitOfMeasure': 'picograms per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in BNP From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.45', 'spread': '10.65', 'groupId': 'OG000', 'lowerLimit': '10.65'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were tested for the participants. When both tests were available, NT-proBNP was chosen over BNP and the same test was performed at every required visit.', 'unitOfMeasure': 'Picograms per milliliter (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Evaluated by SF-10 Questionnaire From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Physical summary score', 'categories': [{'measurements': [{'value': '5.79', 'spread': '12.46', 'groupId': 'OG000', 'lowerLimit': '12.46'}]}]}, {'title': 'Psychosocial summary score', 'categories': [{'measurements': [{'value': '1.10', 'spread': '6.85', 'groupId': 'OG000', 'lowerLimit': '6.85'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'SF-10 is a parent-completed health survey for children that contains 10 questions adapted from the Child Health Questionnaire. It is scored using nom-based scoring to produce physical and psychosocial health summary measures. The possible range for the physical measure is -10.9 to 57.2 scores and the possible range for the psychosocial measure is 8.8 to 62.3 scores. Higher scores indicate more favorable functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Evaluated by PedsQL Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Total scale score', 'categories': [{'measurements': [{'value': '3.49', 'spread': '10.81', 'groupId': 'OG000', 'lowerLimit': '10.81'}]}]}, {'title': 'Physical health summary score', 'categories': [{'measurements': [{'value': '4.28', 'spread': '13.51', 'groupId': 'OG000', 'lowerLimit': '13.51'}]}]}, {'title': 'Psychosocial health summary score', 'categories': [{'measurements': [{'value': '3.07', 'spread': '11.21', 'groupId': 'OG000', 'lowerLimit': '11.21'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'The PedsQL Generic Core Scales were designed to measure health-related quality of life in children and adolescents. It has 4 dimensions: physical functioning, emotional functioning, social functioning and school functioning. 3 Summary Scores of PedsQL were calculated from the scales including total scale score (23 questions), physical health summary score (physical functioning, 8 questions) and psychosocial health summary score (emotional, social and school functioning, 15 questions). Responses of the questions are transformed to a 0-100 scale. Higher scores indicate better quality of life.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Clinical Worsening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 24 (plus/minus 5 days)', 'description': "Clinical worsening was defined as: hospitalization for right heart failure, death, lung transplantation, Pott's anastomosis and atrioseptostomy, worsening of pulmonary arterial hypertension (PAH) symptoms, which must include either an increase in World Health Organization (WHO) functional class or appearance/worsening symptoms of right heart failure and need for additional PAH therapy.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Estimated Right Atrial Pressure From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Estimated right atrial pressure was measured by echocardiography.', 'unitOfMeasure': 'millimetre of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Left Ventricular Eccentricity Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.002', 'spread': '0.907', 'groupId': 'OG000', 'lowerLimit': '0.907'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Left ventricular (LV) eccentricity index (EI) was measured by echocardiography and defined as the ratio of the LV anteroposterior dimension to the septolateral dimension in the parasternal short-axis window by echocardiography. The value of EI greater than 1.0 is abnormal and suggests right ventricle (RV) overload.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Pericardial Effusion From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.040', 'spread': 'NA', 'comment': 'Value was not calculated due to very low number of participants.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Pericardial effusion was measured by echocardiography.', 'unitOfMeasure': 'Millimeter (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Pulmonary Artery Acceleration Time From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.777', 'spread': '35.898', 'groupId': 'OG000', 'lowerLimit': '35.898'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Pulmonary artery acceleration time was measured by echocardiography.', 'unitOfMeasure': 'Millisecond (msec)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular Cardiac Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.188', 'spread': '2.094', 'groupId': 'OG000', 'lowerLimit': '2.094'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricle (RV) cardiac index (CI) was measured by echocardiography and calculated by dividing the cardiac output (stroke volume × heart rate) by the body surface area. The change in RV CI should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Liter/minute/square meter (L/min/m^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular Cardiac Output From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.457', 'spread': '3.066', 'groupId': 'OG000', 'lowerLimit': '3.066'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular cardiac output was measured by echocardiography.', 'unitOfMeasure': 'Liter per minute (L/min)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Atrial Diastolic Area From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.078', 'spread': '3.330', 'groupId': 'OG000', 'lowerLimit': '3.330'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right atrial diastolic area was measured by echocardiography.', 'unitOfMeasure': 'Square centimeter (cm^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Atrial Diastolic Area Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.643', 'spread': '2.314', 'groupId': 'OG000', 'lowerLimit': '2.314'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right atrial (RA) diastolic area index was measured by echocardiography and calculated by dividing the RA area at end-diastole by the body surface area. The RA area index is a reflection of RA volume at end-diastole. The change in the index should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Atrial Systolic Area From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.424', 'spread': '3.758', 'groupId': 'OG000', 'lowerLimit': '3.758'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right atrial systolic area was measured by echocardiography.', 'unitOfMeasure': 'Square centimeter (cm^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Atrial Systolic Area Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.329', 'spread': '2.417', 'groupId': 'OG000', 'lowerLimit': '2.417'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right atrial (RA) systolic area index was measured by echocardiography and calculated by dividing the RA area at end-systole by the body surface area. The RA area index is a reflection of RA volume at end-systole. The change in the index should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular Fractional Area Change From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '7.3', 'groupId': 'OG000', 'lowerLimit': '7.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular fractional area change was measured by echocardiography.', 'unitOfMeasure': 'Percentage (%) of area', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular Diastolic Area From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.618', 'spread': '4.519', 'groupId': 'OG000', 'lowerLimit': '4.519'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular diastolic area was measured by echocardiography.', 'unitOfMeasure': 'Square centimeter (cm^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular Diastolic Area Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.451', 'spread': '3.562', 'groupId': 'OG000', 'lowerLimit': '3.562'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular (RV) diastolic area index was measured by echocardiography and calculated by dividing the RV area at end-diastole by the body surface area. The RV area index is a reflection of RV volume at end-diastole. The change in the index should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular Systolic Area From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.725', 'spread': '3.847', 'groupId': 'OG000', 'lowerLimit': '3.847'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular systolic area was measured by echocardiography.', 'unitOfMeasure': 'Square centimeter (cm^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Right Ventricular Systolic Area Index From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.244', 'spread': '3.277', 'groupId': 'OG000', 'lowerLimit': '3.277'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular (RV) systolic area index was measured by echocardiography and calculated by dividing the RV area at end-systole by the body surface area. The RV area index is a reflection of RV volume at end-systole. The change in the index should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Systolic Pulmonary Artery Pressure From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '49.0', 'groupId': 'OG000', 'lowerLimit': '49.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Systolic pulmonary artery pressure was measured by echocardiography.', 'unitOfMeasure': 'millimetre of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Tricuspid Annular Plane Systolic Excursion From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.27', 'spread': '3.87', 'groupId': 'OG000', 'lowerLimit': '3.87'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Tricuspid annular plane systolic excursion (TAPSE) was measured by echocardiography.', 'unitOfMeasure': 'Millimeter (mm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'SECONDARY', 'title': 'Change in Tricuspid Regurgitation Peak Velocity From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.085', 'spread': '0.726', 'groupId': 'OG000', 'lowerLimit': '0.726'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Tricuspid regurgitation peak velocity was measured by echocardiography.', 'unitOfMeasure': 'Meter/second (m/s)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taste and Texture (Questions 1 to 4) of the Oral Suspension of Riociguat at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Like the look of the drink', 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Like the smell of the drink', 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Like the drink', 'categories': [{'title': 'Yes', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Like to drink again', 'categories': [{'title': 'Yes', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Responses to Questions 1 to 4 are reported in this endpoint. Questions 1 and 2 were asked before the participants received the suspension; whereas questions 3 and 4 were asked right after administration of the suspension. Participants were asked to respond to the 4 questions as "yes" (= positive answer), "I do not know/unsure"(= indifferent answer) or "No" (= negative answer).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taste and Texture (Questions 1 to 4) the Oral Suspension of Riociguat at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Like the look of the drink', 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Like the smell of the drink', 'categories': [{'title': 'Yes', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Like the drink', 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Like to drink again', 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Responses to Questions 1 to 4 are reported in this endpoint. Questions 1 and 2 were asked before the participants received the suspension; whereas questions 3 and 4 were asked right after administration of the suspension. Participants were asked to respond to the 4 questions as "yes" (= positive answer), "I do not know/unsure"(= indifferent answer) or "No" (= negative answer).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taste and Texture (Question 5) of the Oral Suspension of Riociguat at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Sweet', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sour', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bitter', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Salty', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Disgusting', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fruity', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 5 "Taste of the drink" is reported in this endpoint. Question 5 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to answer "yes", "I do not know/unsure" or "No" to each taste including "sweet, sour, bitter, salty, disgusting and fruity".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taste and Texture (Question 5) of the Oral Suspension of Riociguat at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Sweet', 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Sour', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Bitter', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Salty', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Disgusting', 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Fruity', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 5 "Taste of the drink" is reported in this endpoint. Question 5 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to answer "yes", "I do not know/unsure" or "No" to each taste including "sweet, sour, bitter, salty, disgusting and fruity".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taste and Texture (Question 6) of the Oral Suspension of Riociguat at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Like Sand', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sticky', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gooey', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Slimy', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Creamy', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 6 "Drink feels in mouth" is reported in this endpoint. Question 6 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to answer "yes", "I do not know/unsure" or "No" to each feeling including "like sand, sticky, gooey, slimy, creamy".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with evaluable data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taste and Texture (Question 6) of the Oral Suspension of Riociguat in Mouth at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'title': 'Like sand', 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Sticky', 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Gooey', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Slimy', 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Creamy', 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Unsure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 6 "Drink feels in mouth" is reported in this endpoint. Question 6 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to answer "yes", "I do not know/unsure" or "No" to each feeling including "like sand, sticky, gooey, slimy, creamy".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with assessment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taste and Texture (Question 7) of the Oral Suspension of Riociguat in Mouth at Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'title': 'Like the taste after swallowing - Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Like the taste after swallowing - No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Like the taste after swallowing - Unsure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 7 "Did you like the taste after swallowing" is reported in this endpoint. Question 7 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to respond as "yes" (= positive answer), "I do not know/unsure"(= indifferent answer) or "No" (= negative answer).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with assessment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Taste and Texture (Question 7) of the Oral Suspension of Riociguat in Mouth at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'title': 'Like the taste after swallowing - Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Like the taste after swallowing - No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Like the taste after swallowing - Unsure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 7 "Did you like the taste after swallowing" is reported in this endpoint. Question 7 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to respond as "yes" (= positive answer), "I do not know/unsure"(= indifferent answer) or "No" (= negative answer).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with assessment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Expression Assessment on the Taste and Texture of Oral Suspension of Riociguat - Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'title': 'Comfortable', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Indifferent', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Displeased', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'The facial expression of the subjects concerning appearance, smell and taste of the suspension of Riociguat was captured by the investigators as "comfortable", "indifferent" and "displeased".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with assessment'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Expression Assessment on the Taste and Texture of Oral Suspension of Riociguat - Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'classes': [{'categories': [{'title': 'Comfortable', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Indifferent', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Displeased', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'The facial expression of the subjects concerning appearance, smell and taste of the suspension of Riociguat was captured by the investigators as "comfortable", "indifferent" and "displeased".', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in safety analysis set (SAF) with assessment'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Study was conducted at multiple centers in 9 countries or regions between 29-Oct-2015 (first participant first visit) and 07-Mar-2020 (last participant last visit of main study part). The long-term extension part of the study is ongoing.', 'preAssignmentDetails': 'A total of 26 participants were screened. Of them, 2 participants were screening failures and 24 participants received study treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Riociguat >=6 to <18 Years', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '2.8', 'groupId': 'BG000', 'lowerLimit': '2.8'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Not reported', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bone age compared to chronological age', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Delayed', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'In accordance', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Advanced', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'X-ray of left hand was performed for each participant and bone age was determined centrally by a specialist. For each participant, bone age was compared to chronological age and assessed as as "delayed, in accordance or advanced".', 'unitOfMeasure': 'Participants'}, {'title': 'WHO functional class', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Class I', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Class II', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Class III', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Class IV', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "The World Health Organization (WHO) functional class describes how severe a patient's pulmonary hypertension (PH) symptoms are. There are four different classes - I is the mildest and IV the most severe form of PH.", 'unitOfMeasure': 'Participants'}, {'title': 'Heart rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '84.5', 'spread': '19.0', 'groupId': 'BG000', 'lowerLimit': '19.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Beats per minute (BPM)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '63.8', 'spread': '7.9', 'groupId': 'BG000', 'lowerLimit': '7.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimetre of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '112.9', 'spread': '10.9', 'groupId': 'BG000', 'lowerLimit': '10.9'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimetre of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Respiratory Rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '19.6', 'spread': '4.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Breath per minute', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': '6-minute walking distance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '442.12', 'spread': '109.67', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': '6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility.', 'unitOfMeasure': 'Meter', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'N-terminal prohormone brain-type natriuretic peptide', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '982.68', 'spread': '1595.77', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were tested for the participants. When both tests were available, NT-proBNP was chosen over BNP and the same test was performed at every required visit.', 'unitOfMeasure': 'Picograms per milliliter (pg/mL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Brain-type natriuretic peptide', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '10.46', 'spread': '9.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were tested for the participants. When both tests were available, NT-proBNP was chosen over BNP and the same test was performed at every required visit.', 'unitOfMeasure': 'Picograms per milliliter (pg/mL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Quality of life evaluated by SF-10 questionnaire physical summary score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.964', 'spread': '13.335', 'groupId': 'BG000', 'lowerLimit': '13.335'}]}]}], 'paramType': 'MEAN', 'description': 'SF-10 is a parent-completed health survey for children that contains 10 questions adapted from the Child Health Questionnaire. It is scored using nom-based scoring to produce physical and psychosocial health summary measures. The possible range for the physical measure is -10.9 to 57.2 scores and higher scores indicate more favorable functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of life evaluated by SF-10 questionnaire psychosocial summary score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48.765', 'spread': '8.263', 'groupId': 'BG000', 'lowerLimit': '8.263'}]}]}], 'paramType': 'MEAN', 'description': 'SF-10 is a parent-completed health survey for children that contains 10 questions adapted from the Child Health Questionnaire. It is scored using nom-based scoring to produce physical and psychosocial health summary measures. The possible range for the psychosocial measure is 8.8 to 62.3 scores and higher scores indicate more favorable functioning.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quality of life evaluated by PedsQL total scale score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.77', 'spread': '16.29', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'PedsQL Generic Core Scales were designed to measure health-related quality of life in children and adolescents. It has 4 dimensions: physical functioning, emotional functioning, social functioning and school functioning. 3 Summary Scores of PedsQL were calculated from the scales including total scale score, physical health summary score (physical functioning) and psychosocial health summary score (emotional, social and school functioning). Responses of the questions are transformed to a 0-100 scale. Higher scores indicate better quality of life.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Quality of life evaluated by PedsQL physical health summary score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '64.43', 'spread': '15.80', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'PedsQL Generic Core Scales were designed to measure health-related quality of life in children and adolescents. It has 4 dimensions: physical functioning, emotional functioning, social functioning and school functioning. 3 Summary Scores of PedsQL were calculated from the scales including total scale score, physical health summary score (physical functioning) and psychosocial health summary score (emotional, social and school functioning). Responses of the questions are transformed to a 0-100 scale. Higher scores indicate better quality of life.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Quality of life evaluated by PedsQL psychosocial health summary score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '72.62', 'spread': '19.20', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'PedsQL Generic Core Scales were designed to PedsQL Generic Core Scales were designed to measure health-related quality of life in children and adolescents. It has 4 dimensions: physical functioning, emotional functioning, social functioning and school functioning. 3 Summary Scores of PedsQL were calculated from the scales including total scale score, physical health summary score (physical functioning) and psychosocial health summary score (emotional, social and school functioning). Responses of the questions are transformed to a 0-100 scale. Higher scores indicate better quality of life.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Estimate right atrial pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '2.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Estimate right atrial pressure was measured by echocardiography.', 'unitOfMeasure': 'millimetre of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Left ventricular eccentricity index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.099', 'spread': '1.275', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Left ventricular (LV) eccentricity index (EI) is defined as the ratio of the LV long axis to the LV transverse diameter, measured at end systole and end diastole by echocardiography. The value of EI \\> 1.0 is abnormal and suggests right ventricle (RV) overload.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Pulmonary artery acceleration time', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '91.568', 'spread': '36.853', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Pulmonary artery acceleration time was measured by echocardiography.', 'unitOfMeasure': 'Millisecond (msec)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right ventricular cardiac index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.343', 'spread': '1.599', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right ventricle (RV) cardiac index (CI) was measured by echocardiography and calculated by dividing the cardiac output (stroke volume × heart rate) by the body surface area. The change in RV CI should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Liter/minute/square meter (L/min/m^2)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right ventricular cardiac output', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '5.511', 'spread': '2.093', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right ventricular cardiac output was measured by echocardiography.', 'unitOfMeasure': 'Liter per minute (L/min)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right atrial diastolic area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.944', 'spread': '11.071', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right atrial diastolic area was measured by echocardiography. Number of subjects with right atrial diastolic area data at baseline: n=18', 'unitOfMeasure': 'Square centimeter (cm^2)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right atrial diastolic area index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12.788', 'spread': '6.977', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right atrial (RA) diastolic area index was measured by echocardiography and calculated by dividing the RA area at end-diastole by the body surface area. The RA area index is a reflection of RA volume at end-diastole. The change in the index should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right atrial systolic area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '12.017', 'spread': '9.391', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right atrial systolic area was measured by echocardiography.', 'unitOfMeasure': 'Square centimeter (cm^2)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right atrial systolic area index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '8.996', 'spread': '6.021', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right atrial (RA) systolic area index was measured by echocardiography and calculated by dividing the RA area at end-systole by the body surface area. The RA area index is a reflection of RA volume at end-systole. The change in the index should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right ventricular fractional area change', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.7', 'spread': '8.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right ventricular fractional area change was measured by echocardiography.', 'unitOfMeasure': 'Percentage (%)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right ventricular diastolic area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.155', 'spread': '11.993', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right ventricular diastolic area was measured by echocardiography.', 'unitOfMeasure': 'Square centimeter (cm^2)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right ventricular diastolic area index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20.722', 'spread': '6.564', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right ventricular (RV) diastolic area index was measured by echocardiography and calculated by dividing the RV area at end-diastole by the body surface area. The RV area index is a reflection of RV volume at end-diastole. The change in the index should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right ventricular systolic area', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20.235', 'spread': '9.343', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right ventricular systolic area was measured by echocardiography.', 'unitOfMeasure': 'Square centimeter (cm^2)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Right ventricular systolic area index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '15.613', 'spread': '5.745', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Right ventricular (RV) systolic area index was measured by echocardiography and calculated by dividing the RV area at end-systole by the body surface area. The RV area index is a reflection of RV volume at end-systole. The change in the index should not be understood solely but associated with other conditions of the participants.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Systolic pulmonary artery pressure', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '117.2', 'spread': '51.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Systolic pulmonary artery pressure was measured by echocardiography.', 'unitOfMeasure': 'millimetre of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Tricuspid annular plane systolic excursion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18.82', 'spread': '4.21', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Tricuspid annular plane systolic excursion was measured by echocardiography.', 'unitOfMeasure': 'Millimeter (mm)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Tricuspid regurgitation peak velocity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.915', 'spread': '1.100', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Tricuspid regurgitation peak velocity was measured by echocardiography.', 'unitOfMeasure': 'Meter/second (m/s)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Pericardial effusion', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '1.280', 'spread': '0.212', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Pericardial effusion was measured by echocardiography.', 'unitOfMeasure': 'Millimeter (mm)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Platelets', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '218.8', 'spread': '50.6', 'groupId': 'BG000', 'lowerLimit': '50.6'}]}]}], 'paramType': 'MEAN', 'description': 'Hematology parameters were collected and analyzed.', 'unitOfMeasure': 'Giga platelets per liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Lymphocytes/leucocytes ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '48.98', 'spread': '8.15', 'groupId': 'BG000', 'lowerLimit': '8.15'}]}]}], 'paramType': 'MEAN', 'description': 'Hematology parameters were collected and analyzed.', 'unitOfMeasure': 'Percentage of leucocytes in blood', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Neutrophils/leucocytes ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18.71', 'spread': '10.37', 'groupId': 'BG000', 'lowerLimit': '10.37'}]}]}], 'paramType': 'MEAN', 'description': 'Hematology parameters were collected and analyzed.', 'unitOfMeasure': 'Percentage of leucocytes in blood', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Alanine aminotransferase', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '18.71', 'spread': '10.37', 'groupId': 'BG000', 'lowerLimit': '10.37'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical chemistry parameters were collected and analyzed.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Aspartate aminotransferase', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '23.76', 'spread': '8.38', 'groupId': 'BG000', 'lowerLimit': '8.38'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical chemistry parameters were collected and analyzed.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Urea', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '25.17', 'spread': '7.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical chemistry parameters were collected and analyzed.', 'unitOfMeasure': 'microgram per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Gamma glutamyl transferase', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '14.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical chemistry parameters were collected and analyzed.', 'unitOfMeasure': 'Units per liter (U/L)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Blood urea nitrogen', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '4.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical chemistry parameters were collected and analyzed.', 'unitOfMeasure': 'microgram per deciliter (mg/dL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}, {'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '117.877', 'spread': '30.649', 'groupId': 'BG000', 'lowerLimit': '30.649'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical chemistry parameters were collected and analyzed.', 'unitOfMeasure': 'milliliter/minute/1.73 square meter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sodium', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '140.5', 'spread': '2.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Clinical chemistry parameters were collected and analyzed.', 'unitOfMeasure': 'millimole per Liter (mmol/L)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants in SAF with evaluable data for this measurement'}], 'populationDescription': 'Safety analysis set (SAF): All participants who were assigned to receive study medication and had received at least one dose of the study medication.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-20', 'size': 5687255, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-04T22:11', 'hasProtocol': True}, {'date': '2020-02-17', 'size': 627972, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-04T22:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-08-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2015-09-28', 'resultsFirstSubmitDate': '2021-03-04', 'studyFirstSubmitQcDate': '2015-09-28', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2021-04-23', 'studyFirstPostDateStruct': {'date': '2015-09-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Taste and Texture (Questions 1 to 4) of the Oral Suspension of Riociguat at Week 0', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Responses to Questions 1 to 4 are reported in this endpoint. Questions 1 and 2 were asked before the participants received the suspension; whereas questions 3 and 4 were asked right after administration of the suspension. Participants were asked to respond to the 4 questions as "yes" (= positive answer), "I do not know/unsure"(= indifferent answer) or "No" (= negative answer).'}, {'measure': 'Taste and Texture (Questions 1 to 4) the Oral Suspension of Riociguat at Week 24', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Responses to Questions 1 to 4 are reported in this endpoint. Questions 1 and 2 were asked before the participants received the suspension; whereas questions 3 and 4 were asked right after administration of the suspension. Participants were asked to respond to the 4 questions as "yes" (= positive answer), "I do not know/unsure"(= indifferent answer) or "No" (= negative answer).'}, {'measure': 'Taste and Texture (Question 5) of the Oral Suspension of Riociguat at Week 0', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 5 "Taste of the drink" is reported in this endpoint. Question 5 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to answer "yes", "I do not know/unsure" or "No" to each taste including "sweet, sour, bitter, salty, disgusting and fruity".'}, {'measure': 'Taste and Texture (Question 5) of the Oral Suspension of Riociguat at Week 24', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 5 "Taste of the drink" is reported in this endpoint. Question 5 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to answer "yes", "I do not know/unsure" or "No" to each taste including "sweet, sour, bitter, salty, disgusting and fruity".'}, {'measure': 'Taste and Texture (Question 6) of the Oral Suspension of Riociguat at Week 0', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 6 "Drink feels in mouth" is reported in this endpoint. Question 6 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to answer "yes", "I do not know/unsure" or "No" to each feeling including "like sand, sticky, gooey, slimy, creamy".'}, {'measure': 'Taste and Texture (Question 6) of the Oral Suspension of Riociguat in Mouth at Week 24', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 6 "Drink feels in mouth" is reported in this endpoint. Question 6 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to answer "yes", "I do not know/unsure" or "No" to each feeling including "like sand, sticky, gooey, slimy, creamy".'}, {'measure': 'Taste and Texture (Question 7) of the Oral Suspension of Riociguat in Mouth at Week 0', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 7 "Did you like the taste after swallowing" is reported in this endpoint. Question 7 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to respond as "yes" (= positive answer), "I do not know/unsure"(= indifferent answer) or "No" (= negative answer).'}, {'measure': 'Taste and Texture (Question 7) of the Oral Suspension of Riociguat in Mouth at Week 24', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'To assess the taste and texture of oral suspension of Riociguat, a questionnaire including 7 questions was used. Number of participants per responses to Questions 7 "Did you like the taste after swallowing" is reported in this endpoint. Question 7 was only asked to participants who answered "No" to Question 3 "Did you like the drink" or Question 4 "Would you like to drink this again". Participants were asked to respond as "yes" (= positive answer), "I do not know/unsure"(= indifferent answer) or "No" (= negative answer).'}, {'measure': 'Expression Assessment on the Taste and Texture of Oral Suspension of Riociguat - Week 0', 'timeFrame': 'At the beginning of the treatment (Week 0)', 'description': 'The facial expression of the subjects concerning appearance, smell and taste of the suspension of Riociguat was captured by the investigators as "comfortable", "indifferent" and "displeased".'}, {'measure': 'Expression Assessment on the Taste and Texture of Oral Suspension of Riociguat - Week 24', 'timeFrame': 'Week 24 (plus/minus 5 days)', 'description': 'The facial expression of the subjects concerning appearance, smell and taste of the suspension of Riociguat was captured by the investigators as "comfortable", "indifferent" and "displeased".'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Any Treatment-emergent Adverse Events', 'timeFrame': 'From start of study drug up to 2 days after the last dose of study drug in the main study part, up to 24 weeks plus/minus 5 days.', 'description': 'An adverse event (AE), including AE in relation to a medical device (i.e. Raumedic dosing pipette), is any untoward medical occurrence in a participant administered with a pharmaceutical product and does not necessarily have to have a causal relationship with this treatment. A serious AE (SAE) is any untoward medical occurrence that at any dose is resulting in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity. AEs occurring between start of study drug and up to 2 days after the last dose were defined as treatment-emergent AEs (TEAEs).'}, {'measure': 'Change in Heart Rate From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Mean change in heart rate from baseline is reported.'}, {'measure': 'Change in Blood Pressure From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Mean changes in systolic blood pressure (SBP) and diastolic blood pressure (DBP) from baseline are reported.'}, {'measure': 'Change in Respiratory Rate From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Mean change in respiratory rate from baseline is reported.'}, {'measure': 'Number of Subjects With Transitions From Baseline in Bone Age Compared to Chronological Age', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'X-ray of left hand was performed for each participant and bone age was determined centrally by a specialist. For each participant, the bone age was compared to the chronological age and assigned to one of the categories - "delayed", "in accordance" or "advanced", indicating the advancement or delay in the growth of the bone. Number of participants who transitioned to another category different from baseline was calculated and is reported.'}, {'measure': 'Change in Hematology Parameters (Platelets) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Hematology parameters were collected. Parameters with a decrease or increase in the mean value compared to baseline are reported in this data set.'}, {'measure': 'Change in Hematology Parameters (Lymphocytes/Leucocytes Ratio) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Hematology parameters were collected. Parameters with a decrease or increase in the mean value compared to baseline are reported in this data set.'}, {'measure': 'Change in Hematology Parameter (Neutrophils/Leucocytes Ratio) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Hematology parameters were collected. Parameters with a decrease or increase in the mean value compared to baseline are reported in this data set.'}, {'measure': 'Change in Clinical Chemistry (Alanine Aminotransferase) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.'}, {'measure': 'Change in Clinical Chemistry (Aspartate Aminotransferase) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.'}, {'measure': 'Change in Clinical Chemistry (Sodium) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.'}, {'measure': 'Change in Clinical Chemistry (Blood Urea Nitrogen) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.'}, {'measure': 'Change in Clinical Chemistry (eGFR) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set. eGFR = estimated glomerular filtration rate'}, {'measure': 'Change in Clinical Chemistry (Urea) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.'}, {'measure': 'Change in Clinical Chemistry (Gamma Glutamyl Transferase) From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Clinical chemistry parameters were collected and analyzed. Parameters with a trend to lower or higher mean values from baseline are reported in this data set.'}, {'measure': 'Plasma Concentration of Riociguat at Week 0', 'timeFrame': 'Week 0 (30-90 minutes post-dose; 2.5-4 hours post-dose)', 'description': 'For each participant, one blood sample was collected at one given time point. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported. W = Week.'}, {'measure': 'Plasma Concentration of Riociguat at Week 4', 'timeFrame': 'Week 4 (pre-dose)', 'description': 'For each participant, one blood sample was collected at one given time point. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported.'}, {'measure': 'Plasma Concentration of Riociguat at Week 8', 'timeFrame': 'Week 8 (pre-dose)', 'description': 'For each participant, one blood sample was collected at one given time point. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported.'}, {'measure': 'Plasma Concentration of BAY60-4552 at Week 0', 'timeFrame': 'Week 0 (30-90 minutes post-dose; 2.5-4 hours post-dose)', 'description': "BAY60-4552 is riociguat's active metabolite. For each participant, one blood sample was collected at one given time point and in that sample both riociguat and BAY60-4552 were measured. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported. W = Week"}, {'measure': 'Plasma Concentration of BAY60-4552 at Week 4', 'timeFrame': 'Week 4 (pre-dose)', 'description': "BAY60-4552 is riociguat's active metabolite. For each participant, one blood sample was collected at one given time point and in that sample both riociguat and BAY60-4552 were measured. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported."}, {'measure': 'Plasma Concentration of BAY60-4552 at Week 8', 'timeFrame': 'Week 8 (pre-dose)', 'description': "BAY60-4552 is riociguat's active metabolite. For each participant, one blood sample was collected at one given time point and in that sample both riociguat and BAY60-4552 were measured. Values below lower limit of quantification (LLOQ) were substituted by 1/2 LLOQ for the calculation in statistics. Means at any time were only calculated if at least 2/3 of the individual data were measured and were above the limit of quantification (LOQ). Geometric mean and percentage geometric coefficient of variation (%CV) are reported."}], 'secondaryOutcomes': [{'measure': 'Change in 6-minute Walking Distance From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': '6-minute walking distance (6MWD) is a exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. An increase in the distance walked indicates improvement in basic mobility.'}, {'measure': 'Number of Subjects With Change in WHO Functional Class From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': "The World Health Organization (WHO) functional class describes how severe a patient's pulmonary hypertension (PH) symptoms are. There are four different classes - I is the mildest and IV the most severe form of PH. Number of participants per change in number of classes is reported."}, {'measure': 'Change in NT-proBNP From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were tested for the participants. When both tests were available, NT-proBNP was chosen over BNP and the same test was performed at every required visit.'}, {'measure': 'Change in BNP From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Laboratory biomarkers N-terminal prohormone brain-type natriuretic peptide (NT-proBNP) or brain-type natriuretic peptide (BNP) were tested for the participants. When both tests were available, NT-proBNP was chosen over BNP and the same test was performed at every required visit.'}, {'measure': 'Change in Quality of Life Evaluated by SF-10 Questionnaire From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'SF-10 is a parent-completed health survey for children that contains 10 questions adapted from the Child Health Questionnaire. It is scored using nom-based scoring to produce physical and psychosocial health summary measures. The possible range for the physical measure is -10.9 to 57.2 scores and the possible range for the psychosocial measure is 8.8 to 62.3 scores. Higher scores indicate more favorable functioning.'}, {'measure': 'Change in Quality of Life Evaluated by PedsQL Scale', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'The PedsQL Generic Core Scales were designed to measure health-related quality of life in children and adolescents. It has 4 dimensions: physical functioning, emotional functioning, social functioning and school functioning. 3 Summary Scores of PedsQL were calculated from the scales including total scale score (23 questions), physical health summary score (physical functioning, 8 questions) and psychosocial health summary score (emotional, social and school functioning, 15 questions). Responses of the questions are transformed to a 0-100 scale. Higher scores indicate better quality of life.'}, {'measure': 'Number of Subjects With Clinical Worsening', 'timeFrame': 'Up to Week 24 (plus/minus 5 days)', 'description': "Clinical worsening was defined as: hospitalization for right heart failure, death, lung transplantation, Pott's anastomosis and atrioseptostomy, worsening of pulmonary arterial hypertension (PAH) symptoms, which must include either an increase in World Health Organization (WHO) functional class or appearance/worsening symptoms of right heart failure and need for additional PAH therapy."}, {'measure': 'Change in Estimated Right Atrial Pressure From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Estimated right atrial pressure was measured by echocardiography.'}, {'measure': 'Change in Left Ventricular Eccentricity Index From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Left ventricular (LV) eccentricity index (EI) was measured by echocardiography and defined as the ratio of the LV anteroposterior dimension to the septolateral dimension in the parasternal short-axis window by echocardiography. The value of EI greater than 1.0 is abnormal and suggests right ventricle (RV) overload.'}, {'measure': 'Change in Pericardial Effusion From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Pericardial effusion was measured by echocardiography.'}, {'measure': 'Change in Pulmonary Artery Acceleration Time From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Pulmonary artery acceleration time was measured by echocardiography.'}, {'measure': 'Change in Right Ventricular Cardiac Index From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricle (RV) cardiac index (CI) was measured by echocardiography and calculated by dividing the cardiac output (stroke volume × heart rate) by the body surface area. The change in RV CI should not be understood solely but associated with other conditions of the participants.'}, {'measure': 'Change in Right Ventricular Cardiac Output From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular cardiac output was measured by echocardiography.'}, {'measure': 'Change in Right Atrial Diastolic Area From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right atrial diastolic area was measured by echocardiography.'}, {'measure': 'Change in Right Atrial Diastolic Area Index From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right atrial (RA) diastolic area index was measured by echocardiography and calculated by dividing the RA area at end-diastole by the body surface area. The RA area index is a reflection of RA volume at end-diastole. The change in the index should not be understood solely but associated with other conditions of the participants.'}, {'measure': 'Change in Right Atrial Systolic Area From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right atrial systolic area was measured by echocardiography.'}, {'measure': 'Change in Right Atrial Systolic Area Index From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right atrial (RA) systolic area index was measured by echocardiography and calculated by dividing the RA area at end-systole by the body surface area. The RA area index is a reflection of RA volume at end-systole. The change in the index should not be understood solely but associated with other conditions of the participants.'}, {'measure': 'Change in Right Ventricular Fractional Area Change From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular fractional area change was measured by echocardiography.'}, {'measure': 'Change in Right Ventricular Diastolic Area From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular diastolic area was measured by echocardiography.'}, {'measure': 'Change in Right Ventricular Diastolic Area Index From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular (RV) diastolic area index was measured by echocardiography and calculated by dividing the RV area at end-diastole by the body surface area. The RV area index is a reflection of RV volume at end-diastole. The change in the index should not be understood solely but associated with other conditions of the participants.'}, {'measure': 'Change in Right Ventricular Systolic Area From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular systolic area was measured by echocardiography.'}, {'measure': 'Change in Right Ventricular Systolic Area Index From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Right ventricular (RV) systolic area index was measured by echocardiography and calculated by dividing the RV area at end-systole by the body surface area. The RV area index is a reflection of RV volume at end-systole. The change in the index should not be understood solely but associated with other conditions of the participants.'}, {'measure': 'Change in Systolic Pulmonary Artery Pressure From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Systolic pulmonary artery pressure was measured by echocardiography.'}, {'measure': 'Change in Tricuspid Annular Plane Systolic Excursion From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Tricuspid annular plane systolic excursion (TAPSE) was measured by echocardiography.'}, {'measure': 'Change in Tricuspid Regurgitation Peak Velocity From Baseline', 'timeFrame': 'Baseline and Week 24 (plus/minus 5 days)', 'description': 'Tricuspid regurgitation peak velocity was measured by echocardiography.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary arterial hypertension'], 'conditions': ['Hypertension, Pulmonary']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.clinicaltrialsregister.eu/', 'label': 'Click here to find information about studies related to Bayer Healthcare products conducted in Europe'}, {'url': 'https://clinicaltrials.bayer.com/', 'label': 'Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary arterial hypertension (PAH) group 1. The study design consisted of a main study part followed by an optional long-term extension part. The main treatment period consisted of two phases: titration phase up to 8 weeks and a maintenance phase up to 16 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children from 6 years to less than 18 years of age with pulmonary arterial hypertension (PAH)\n* Diagnosed with PAH :\n\n * Idiopathic (IPAH)\n * Hereditable (HPAH)\n * PAH associated with (APAH)\n\n * Connective tissue disease\n * Congenital heart disease with shunt closure more than 6 months ago (no open shunts, confirmed by RHC no less than 4 months after surgery)\n\nRegardless of the type of PAH, the following findings are not exclusionary:\n\n\\--- Patent foramen ovale (PFO) and asymptomatic, isolated, ostium secundum atrial septal defect (OS-ASD) ≤ 1 cm (both confirmed by echocardiogram) and not associated with hemodynamic alterations indicative of significant shunt, e.g. Qp/Qs ratio less \\<1.5:1 are not exclusionary\n\n* PAH diagnosed by right heart catheterization (RHC) at any time prior to enrolment (for patients with closed shunts - RHC no less than 4 months after surgery)\n* PAH confirmed by a RHC at any time prior to start of study, with mean pulmonary artery pressure (PAPmean) ≥25 mmHg at rest, pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg, and pulmonary vascular resistance (PVR) \\>240 dyn•sec•cm\\^-5 (i.e., ≥3.0 wood units•m\\^2)\n* Patients must be on standard of care PAH medications, allowing Endothelin Receptor Antagonists (ERA) and/or Prostacyclin Analogues (PCA), for at least 12 weeks prior to baseline visit.\n\nTwo groups of patients will be included:\n\n* Prevalent: Patients currently on PAH medication (allowing ERA and/or PCA) who need additional treatment (discretion of the investigator)\n* Incident: Treatment naïve patients initiated on PAH medication (allowing ERA and /or PCA) and then riociguat added once patients are stable on standard of care\n\n * WHO functional class I-III\n * Adolescent females of childbearing potential can only be included in the study if a pregnancy test is negative. Adolescent females of childbearing potential must agree to receive sexual counseling and use effective contraception as applicable. 'Effective contraception' is defined as progestogen-only hormonal contraception associated with inhibition of ovulation (implant), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), or any combination of adequate methods of birth control (e.g. condoms with hormonal contraception). Agreement to use contraception is required from the signing of the informed consent form up until 4 weeks after the last study drug administration.\n * Young men must agree to use adequate contraception when sexually active.\n * Written inform consent provided and if applicable child assent provided\n\nExclusion Criteria:\n\n* Concomitant use of the following medications: phosphodiesterase (PDE) 5 inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific phosphodiesterase (PDE) inhibitors (theophylline, dipyridamole), nitrates or NO donors (such as amyl nitrite) in any form\n\n \\-- Pretreatment with NO donors (e.g. nitrates) within the last 2-weeks before visit 1. The use of any drug including NO acutely for testing during catheterization is not an exclusion criterion.\n* Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization or any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening\n* Systolic blood pressure (SBP) more than 5 mmHg lower than the age-, sex- and height-adapted level of the 50th SBP percentile (NHBPEP, 2004)\n* History of left-sided heart disease, including valvular disease or heart failure\n* Pulmonary hypertension related to conditions other than specified in the inclusion criteria\n* WHO functional class IV\n* Pulmonary veno-occlusive disease\n* Screening aspartate transaminase (AST) and/ or alanine transaminase (ALT) more than 3 times the upper limit of normal (ULN)\n* Severe restrictive lung disease\n* Severe congenital abnormalities of the lung, thorax, and diaphragm\n* Clinically relevant hepatic dysfunction (especially Child Pugh C)\n* Renal insufficiency (estimated glomerular filtration rate \\<30 mL/min/1.73m\\^2 e.g. calculated based on Schwartz formula)\n* PH associated with idiopathic interstitial pneumonia (PH-IIP)"}, 'identificationModule': {'nctId': 'NCT02562235', 'acronym': 'PATENT-CHILD', 'briefTitle': 'Riociguat in Children With Pulmonary Arterial Hypertension (PAH)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Open-label, Individual Dose Titration Study to Evaluate Safety, Tolerability and Pharmacokinetics of Riociguat in Children From 6 to Less Than 18 Years of Age With Pulmonary Arterial Hypertension (PAH)', 'orgStudyIdInfo': {'id': '15681'}, 'secondaryIdInfos': [{'id': '2014-003952-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Riociguat', 'description': 'Participants with age ≥6 to \\<18 years received riociguat up to 2.5 mg three times a day (titration between 1.0 mg and 2.5 mg) for up to 8 weeks during the individual dose titration (IDT) phase, and followed with the last dose administered in the IDT phase for up to 16 weeks during the maintenance phase. Down-titration (up to 0.5 mg) of the dose for safety reasons was allowed at any time.', 'interventionNames': ['Drug: Riociguat (Adempas, BAY63-2521)']}], 'interventions': [{'name': 'Riociguat (Adempas, BAY63-2521)', 'type': 'DRUG', 'description': 'For children with body-weight \\<50 kg at screening: body-weight adjusted dose equivalent to the exposure of (0.5 mg) 1.0 - 2.5 mg three times a day, IDT in adults treated for PAH; oral suspension. For children ≥50 kg at screening: 1.0 to 2.5 mg three times a day; oral tablet.', 'armGroupLabels': ['Riociguat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '760042', 'city': 'Cali', 'state': 'Valle del Cauca Department', 'country': 'Colombia', 'facility': 'Clínica Imbanaco S.A.S', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '69115', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '89075', 'city': 'Ulm', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Universitätsklinikum Ulm', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Deutsches Herzzentrum der Charité (DHZC)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '1096', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'SZTE ÁOK Szent Györgyi Albert Klinikai Kozpont', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '35128', 'city': 'Padua', 'state': 'Veneto', 'country': 'Italy', 'facility': 'Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '474-8710', 'city': 'Ōbu', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': "Aichi Children's Health and Medical Center", 'geoPoint': {'lat': 35.01756, 'lon': 136.94947}}, {'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'The University of Osaka Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '565-8565', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'National Cerebral and Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '160-8582', 'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Keio University Hospital'}, {'zip': '14080', 'city': 'México D.F.', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Instituto Nacional de Cardiología "Ignacio Chávez"'}, {'zip': '52763', 'city': 'Huixquilucan', 'country': 'Mexico', 'facility': 'Operadora de Hospitales Angeles S. A. de C. V.', 'geoPoint': {'lat': 19.35985, 'lon': -99.35016}}, {'zip': '51-124', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Wojewodzki Szpital Specjalistyczny - Wroclaw', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '813414', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '6100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe Universitesi Tip Fakultesi', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Availability of this study\'s data will later be determined according to Bayer\'s commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.\n\nInterested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}