Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT04364269
Status:
COMPLETED
Last Update Posted:
2023-12-14
First Post:
2020-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017086', 'term': 'beta-Thalassemia'}], 'ancestors': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C494814', 'term': 'BID protein, human'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'VIT2763-THAL-201.study@viforpharma.com', 'phone': '+41 588 518 000', 'title': 'CSL Vifor', 'organization': 'Vifor Pharma, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'up to 20 weeks (all visits/phone calls through study completion are considered)', 'eventGroups': [{'id': 'EG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 7, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Photopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Faeces discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Respiratory symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (23.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to Week 16', 'description': 'Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participants, in particular, the number of participants with at least one TEAE. Please refer to the detailed tables included on the Adverse Event Module for specifics.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set (SS) was defined as all randomized participants who had taken at least 1 dose of study medication. The participants in the SS were to be analyzed based on the treatment they received, regardless of randomization.'}, {'type': 'PRIMARY', 'title': 'Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'classes': [{'title': 'SBP Baseline', 'categories': [{'measurements': [{'value': '114.2', 'spread': '11.62', 'groupId': 'OG000'}, {'value': '114.7', 'spread': '13.88', 'groupId': 'OG001'}, {'value': '114.8', 'spread': '12.97', 'groupId': 'OG002'}]}]}, {'title': 'SBP Week 1', 'categories': [{'measurements': [{'value': '115.0', 'spread': '8.35', 'groupId': 'OG000'}, {'value': '116.7', 'spread': '10.65', 'groupId': 'OG001'}, {'value': '104.0', 'spread': '8.98', 'groupId': 'OG002'}]}]}, {'title': 'SBP Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '0.8', 'spread': '8.94', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '9.72', 'groupId': 'OG001'}, {'value': '-10.8', 'spread': '10.90', 'groupId': 'OG002'}]}]}, {'title': 'SBP Week 2', 'categories': [{'measurements': [{'value': '113.9', 'spread': '9.41', 'groupId': 'OG000'}, {'value': '118.3', 'spread': '14.85', 'groupId': 'OG001'}, {'value': '114.8', 'spread': '15.06', 'groupId': 'OG002'}]}]}, {'title': 'SBP Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '-0.3', 'spread': '6.60', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '8.78', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '2.83', 'groupId': 'OG002'}]}]}, {'title': 'SBP Week 4', 'categories': [{'measurements': [{'value': '112.0', 'spread': '11.20', 'groupId': 'OG000'}, {'value': '113.9', 'spread': '12.41', 'groupId': 'OG001'}, {'value': '104.8', 'spread': '6.85', 'groupId': 'OG002'}]}]}, {'title': 'SBP Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '8.77', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '8.51', 'groupId': 'OG001'}, {'value': '-10.0', 'spread': '14.72', 'groupId': 'OG002'}]}]}, {'title': 'SBP Week 8', 'categories': [{'measurements': [{'value': '114.9', 'spread': '7.41', 'groupId': 'OG000'}, {'value': '113.8', 'spread': '10.54', 'groupId': 'OG001'}, {'value': '109.8', 'spread': '12.61', 'groupId': 'OG002'}]}]}, {'title': 'SBP Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '0.7', 'spread': '11.11', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '9.63', 'groupId': 'OG001'}, {'value': '-5.0', 'spread': '1.63', 'groupId': 'OG002'}]}]}, {'title': 'SBP Week 12', 'categories': [{'measurements': [{'value': '113.4', 'spread': '11.02', 'groupId': 'OG000'}, {'value': '112.8', 'spread': '11.31', 'groupId': 'OG001'}, {'value': '107.5', 'spread': '10.08', 'groupId': 'OG002'}]}]}, {'title': 'SBP Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.8', 'spread': '13.02', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '10.85', 'groupId': 'OG001'}, {'value': '-7.3', 'spread': '3.40', 'groupId': 'OG002'}]}]}, {'title': 'DBP Baseline', 'categories': [{'measurements': [{'value': '65.94', 'spread': '10.088', 'groupId': 'OG000'}, {'value': '65.00', 'spread': '10.189', 'groupId': 'OG001'}, {'value': '66.50', 'spread': '7.853', 'groupId': 'OG002'}]}]}, {'title': 'DBP Week 1', 'categories': [{'measurements': [{'value': '66.44', 'spread': '6.710', 'groupId': 'OG000'}, {'value': '69.33', 'spread': '9.921', 'groupId': 'OG001'}, {'value': '61.75', 'spread': '4.856', 'groupId': 'OG002'}]}]}, {'title': 'DBP Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '0.50', 'spread': '4.886', 'groupId': 'OG000'}, {'value': '4.33', 'spread': '6.344', 'groupId': 'OG001'}, {'value': '-4.75', 'spread': '6.185', 'groupId': 'OG002'}]}]}, {'title': 'DBP Week 2', 'categories': [{'measurements': [{'value': '65.89', 'spread': '9.545', 'groupId': 'OG000'}, {'value': '68.83', 'spread': '11.535', 'groupId': 'OG001'}, {'value': '64.00', 'spread': '6.055', 'groupId': 'OG002'}]}]}, {'title': 'DBP Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '-0.06', 'spread': '5.353', 'groupId': 'OG000'}, {'value': '3.83', 'spread': '8.726', 'groupId': 'OG001'}, {'value': '-2.50', 'spread': '3.000', 'groupId': 'OG002'}]}]}, {'title': 'DBP Week 4', 'categories': [{'measurements': [{'value': '65.22', 'spread': '11.043', 'groupId': 'OG000'}, {'value': '62.33', 'spread': '9.069', 'groupId': 'OG001'}, {'value': '62.75', 'spread': '3.775', 'groupId': 'OG002'}]}]}, {'title': 'DBP Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-0.72', 'spread': '9.398', 'groupId': 'OG000'}, {'value': '-2.67', 'spread': '9.921', 'groupId': 'OG001'}, {'value': '-3.75', 'spread': '5.058', 'groupId': 'OG002'}]}]}, {'title': 'DBP Week 8', 'categories': [{'measurements': [{'value': '63.44', 'spread': '6.579', 'groupId': 'OG000'}, {'value': '67.18', 'spread': '9.174', 'groupId': 'OG001'}, {'value': '66.75', 'spread': '7.500', 'groupId': 'OG002'}]}]}, {'title': 'DBP Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-2.50', 'spread': '8.216', 'groupId': 'OG000'}, {'value': '3.27', 'spread': '8.439', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '7.848', 'groupId': 'OG002'}]}]}, {'title': 'DBP Week 12', 'categories': [{'measurements': [{'value': '63.67', 'spread': '7.697', 'groupId': 'OG000'}, {'value': '67.64', 'spread': '9.657', 'groupId': 'OG001'}, {'value': '62.50', 'spread': '3.317', 'groupId': 'OG002'}]}]}, {'title': 'DBP Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-2.28', 'spread': '10.140', 'groupId': 'OG000'}, {'value': '3.73', 'spread': '6.310', 'groupId': 'OG001'}, {'value': '-4.00', 'spread': '6.880', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 12', 'description': 'Summary of the values by visit from baseline and changes from baseline by post-baseline visit.', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set (SS) was defined as all randomized participants who had taken at least 1 dose of study medication. The participants in the SS were to be analyzed based on the treatment they received, regardless of randomization.'}, {'type': 'PRIMARY', 'title': 'Changes in the Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '82.00', 'spread': '12.135', 'groupId': 'OG000'}, {'value': '77.71', 'spread': '10.208', 'groupId': 'OG001'}, {'value': '73.75', 'spread': '5.560', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '82.33', 'spread': '11.694', 'groupId': 'OG000'}, {'value': '80.33', 'spread': '9.875', 'groupId': 'OG001'}, {'value': '70.75', 'spread': '6.449', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '0.33', 'spread': '6.042', 'groupId': 'OG000'}, {'value': '2.63', 'spread': '5.859', 'groupId': 'OG001'}, {'value': '-3.00', 'spread': '5.715', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '83.56', 'spread': '12.856', 'groupId': 'OG000'}, {'value': '75.83', 'spread': '9.953', 'groupId': 'OG001'}, {'value': '75.00', 'spread': '8.756', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '1.56', 'spread': '10.442', 'groupId': 'OG000'}, {'value': '-1.88', 'spread': '8.263', 'groupId': 'OG001'}, {'value': '1.25', 'spread': '3.775', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '82.33', 'spread': '14.414', 'groupId': 'OG000'}, {'value': '77.92', 'spread': '9.830', 'groupId': 'OG001'}, {'value': '73.25', 'spread': '3.775', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '0.33', 'spread': '8.818', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '5.541', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '1.915', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '83.22', 'spread': '11.322', 'groupId': 'OG000'}, {'value': '80.27', 'spread': '10.992', 'groupId': 'OG001'}, {'value': '72.50', 'spread': '5.196', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '1.22', 'spread': '6.648', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '9.040', 'groupId': 'OG001'}, {'value': '-1.25', 'spread': '7.411', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '81.44', 'spread': '9.002', 'groupId': 'OG000'}, {'value': '79.91', 'spread': '8.734', 'groupId': 'OG001'}, {'value': '74.25', 'spread': '4.193', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.56', 'spread': '8.719', 'groupId': 'OG000'}, {'value': '2.32', 'spread': '9.419', 'groupId': 'OG001'}, {'value': '0.50', 'spread': '6.137', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 12', 'description': 'Summary of the values by visit from baseline and changes from baseline by post-baseline visit.', 'unitOfMeasure': 'Pulse Rate (bpm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set (SS) was defined as all randomized participants who had taken at least 1 dose of study medication. The participants in the SS were to be analyzed based on the treatment they received, regardless of randomization.'}, {'type': 'PRIMARY', 'title': 'Changes in 12-lead Electrocardiogram (ECG) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'classes': [{'title': 'PR interval - Baseline', 'categories': [{'measurements': [{'value': '158.3', 'spread': '25.14', 'groupId': 'OG000'}, {'value': '147.6', 'spread': '20.05', 'groupId': 'OG001'}, {'value': '175.8', 'spread': '38.92', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '161.2', 'spread': '21.28', 'groupId': 'OG000'}, {'value': '155.1', 'spread': '17.98', 'groupId': 'OG001'}, {'value': '175.0', 'spread': '14.07', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Change from Baseline to Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '2.9', 'spread': '25.78', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '16.45', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '38.59', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Week 1', 'categories': [{'measurements': [{'value': '159.2', 'spread': '22.90', 'groupId': 'OG000'}, {'value': '153.0', 'spread': '14.12', 'groupId': 'OG001'}, {'value': '189.5', 'spread': '18.72', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '0.9', 'spread': '16.59', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '12.71', 'groupId': 'OG001'}, {'value': '13.8', 'spread': '25.67', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Week 2', 'categories': [{'measurements': [{'value': '167.6', 'spread': '26.49', 'groupId': 'OG000'}, {'value': '153.0', 'spread': '17.87', 'groupId': 'OG001'}, {'value': '185.5', 'spread': '4.43', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '9.2', 'spread': '27.64', 'groupId': 'OG000'}, {'value': '5.5', 'spread': '13.56', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '37.56', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Week 4', 'categories': [{'measurements': [{'value': '154.0', 'spread': '26.49', 'groupId': 'OG000'}, {'value': '154.2', 'spread': '21.19', 'groupId': 'OG001'}, {'value': '185.0', 'spread': '7.39', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-4.3', 'spread': '18.85', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '15.48', 'groupId': 'OG001'}, {'value': '9.3', 'spread': '33.42', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Week 8', 'categories': [{'measurements': [{'value': '161.2', 'spread': '19.34', 'groupId': 'OG000'}, {'value': '153.5', 'spread': '20.61', 'groupId': 'OG001'}, {'value': '185.8', 'spread': '10.14', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '2.9', 'spread': '17.05', 'groupId': 'OG000'}, {'value': '7.1', 'spread': '12.66', 'groupId': 'OG001'}, {'value': '10.0', 'spread': '32.86', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Week 12', 'categories': [{'measurements': [{'value': '160.6', 'spread': '19.55', 'groupId': 'OG000'}, {'value': '156.6', 'spread': '14.47', 'groupId': 'OG001'}, {'value': '182.8', 'spread': '11.98', 'groupId': 'OG002'}]}]}, {'title': 'PR interval - Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '2.2', 'spread': '19.50', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '14.25', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '36.09', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Baseline', 'categories': [{'measurements': [{'value': '94.0', 'spread': '18.73', 'groupId': 'OG000'}, {'value': '88.8', 'spread': '19.17', 'groupId': 'OG001'}, {'value': '119.3', 'spread': '50.12', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '94.3', 'spread': '20.21', 'groupId': 'OG000'}, {'value': '95.8', 'spread': '10.96', 'groupId': 'OG001'}, {'value': '85.0', 'spread': '11.60', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Change from Baseline to Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '0.3', 'spread': '4.82', 'groupId': 'OG000'}, {'value': '7.0', 'spread': '14.39', 'groupId': 'OG001'}, {'value': '-34.3', 'spread': '55.27', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Week 1', 'categories': [{'measurements': [{'value': '98.4', 'spread': '23.16', 'groupId': 'OG000'}, {'value': '96.1', 'spread': '11.27', 'groupId': 'OG001'}, {'value': '98.0', 'spread': '16.57', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '4.4', 'spread': '14.75', 'groupId': 'OG000'}, {'value': '7.3', 'spread': '13.45', 'groupId': 'OG001'}, {'value': '-21.3', 'spread': '65.76', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Week 2', 'categories': [{'measurements': [{'value': '94.0', 'spread': '29.01', 'groupId': 'OG000'}, {'value': '96.3', 'spread': '14.13', 'groupId': 'OG001'}, {'value': '91.3', 'spread': '12.09', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '0.0', 'spread': '23.04', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '17.96', 'groupId': 'OG001'}, {'value': '-28.0', 'spread': '61.36', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Week 4', 'categories': [{'measurements': [{'value': '92.3', 'spread': '23.32', 'groupId': 'OG000'}, {'value': '92.6', 'spread': '15.11', 'groupId': 'OG001'}, {'value': '94.3', 'spread': '8.10', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '16.76', 'groupId': 'OG001'}, {'value': '-25.0', 'spread': '54.02', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Week 8', 'categories': [{'measurements': [{'value': '91.0', 'spread': '24.72', 'groupId': 'OG000'}, {'value': '94.9', 'spread': '18.27', 'groupId': 'OG001'}, {'value': '93.3', 'spread': '10.81', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-3.0', 'spread': '15.99', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '28.52', 'groupId': 'OG001'}, {'value': '-26.0', 'spread': '60.02', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Week 12', 'categories': [{'measurements': [{'value': '94.3', 'spread': '27.31', 'groupId': 'OG000'}, {'value': '84.8', 'spread': '18.66', 'groupId': 'OG001'}, {'value': '91.8', 'spread': '10.59', 'groupId': 'OG002'}]}]}, {'title': 'QRS duration - Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '0.3', 'spread': '20.64', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '23.70', 'groupId': 'OG001'}, {'value': '-27.5', 'spread': '60.69', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Baseline', 'categories': [{'measurements': [{'value': '371.7', 'spread': '76.41', 'groupId': 'OG000'}, {'value': '374.2', 'spread': '21.78', 'groupId': 'OG001'}, {'value': '420.8', 'spread': '48.75', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '385.7', 'spread': '50.89', 'groupId': 'OG000'}, {'value': '376.8', 'spread': '22.25', 'groupId': 'OG001'}, {'value': '379.5', 'spread': '30.17', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Change from Baseline to Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '14.0', 'spread': '61.00', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '21.49', 'groupId': 'OG001'}, {'value': '-41.3', 'spread': '68.30', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Week 1', 'categories': [{'measurements': [{'value': '394.1', 'spread': '47.36', 'groupId': 'OG000'}, {'value': '374.8', 'spread': '33.12', 'groupId': 'OG001'}, {'value': '381.5', 'spread': '32.18', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '22.4', 'spread': '57.20', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '28.96', 'groupId': 'OG001'}, {'value': '-39.3', 'spread': '71.63', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Week 2', 'categories': [{'measurements': [{'value': '384.0', 'spread': '55.52', 'groupId': 'OG000'}, {'value': '367.0', 'spread': '24.68', 'groupId': 'OG001'}, {'value': '378.3', 'spread': '27.89', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '12.3', 'spread': '76.14', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '27.61', 'groupId': 'OG001'}, {'value': '-42.5', 'spread': '61.87', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Week 4', 'categories': [{'measurements': [{'value': '370.1', 'spread': '67.13', 'groupId': 'OG000'}, {'value': '373.6', 'spread': '21.22', 'groupId': 'OG001'}, {'value': '378.0', 'spread': '36.51', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-1.6', 'spread': '23.07', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '24.94', 'groupId': 'OG001'}, {'value': '-42.8', 'spread': '61.50', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Week 8', 'categories': [{'measurements': [{'value': '389.7', 'spread': '39.20', 'groupId': 'OG000'}, {'value': '379.4', 'spread': '25.08', 'groupId': 'OG001'}, {'value': '381.8', 'spread': '37.99', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '18.0', 'spread': '69.60', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '22.59', 'groupId': 'OG001'}, {'value': '-39.0', 'spread': '64.59', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Week 12', 'categories': [{'measurements': [{'value': '380.9', 'spread': '59.97', 'groupId': 'OG000'}, {'value': '364.2', 'spread': '36.22', 'groupId': 'OG001'}, {'value': '388.3', 'spread': '42.85', 'groupId': 'OG002'}]}]}, {'title': 'QT interval - Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '9.2', 'spread': '33.53', 'groupId': 'OG000'}, {'value': '-10.5', 'spread': '33.69', 'groupId': 'OG001'}, {'value': '-32.5', 'spread': '72.06', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Baseline', 'categories': [{'measurements': [{'value': '789.4', 'spread': '128.89', 'groupId': 'OG000'}, {'value': '801.4', 'spread': '95.56', 'groupId': 'OG001'}, {'value': '877.5', 'spread': '114.65', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '781.2', 'spread': '155.21', 'groupId': 'OG000'}, {'value': '805.5', 'spread': '119.36', 'groupId': 'OG001'}, {'value': '812.5', 'spread': '124.38', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Change from Baseline to Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '-8.2', 'spread': '87.78', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '112.91', 'groupId': 'OG001'}, {'value': '-65.0', 'spread': '196.09', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Week 1', 'categories': [{'measurements': [{'value': '793.2', 'spread': '105.35', 'groupId': 'OG000'}, {'value': '864.9', 'spread': '149.33', 'groupId': 'OG001'}, {'value': '826.5', 'spread': '96.57', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '3.8', 'spread': '82.82', 'groupId': 'OG000'}, {'value': '63.5', 'spread': '137.59', 'groupId': 'OG001'}, {'value': '-51.0', 'spread': '98.80', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Week 2', 'categories': [{'measurements': [{'value': '757.3', 'spread': '120.25', 'groupId': 'OG000'}, {'value': '830.1', 'spread': '138.34', 'groupId': 'OG001'}, {'value': '833.8', 'spread': '16.01', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '-32.1', 'spread': '146.70', 'groupId': 'OG000'}, {'value': '28.7', 'spread': '117.34', 'groupId': 'OG001'}, {'value': '-43.8', 'spread': '103.92', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Week 4', 'categories': [{'measurements': [{'value': '783.7', 'spread': '110.55', 'groupId': 'OG000'}, {'value': '829.8', 'spread': '154.72', 'groupId': 'OG001'}, {'value': '825.8', 'spread': '96.08', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-5.8', 'spread': '62.11', 'groupId': 'OG000'}, {'value': '34.1', 'spread': '137.64', 'groupId': 'OG001'}, {'value': '-51.8', 'spread': '111.05', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Week 8', 'categories': [{'measurements': [{'value': '765.0', 'spread': '91.52', 'groupId': 'OG000'}, {'value': '810.1', 'spread': '138.16', 'groupId': 'OG001'}, {'value': '844.8', 'spread': '135.47', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-24.4', 'spread': '116.42', 'groupId': 'OG000'}, {'value': '17.2', 'spread': '108.39', 'groupId': 'OG001'}, {'value': '-32.8', 'spread': '152.45', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Week 12', 'categories': [{'measurements': [{'value': '780.7', 'spread': '140.88', 'groupId': 'OG000'}, {'value': '812.9', 'spread': '93.89', 'groupId': 'OG001'}, {'value': '878.3', 'spread': '133.70', 'groupId': 'OG002'}]}]}, {'title': 'RR interval - Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-8.8', 'spread': '115.95', 'groupId': 'OG000'}, {'value': '20.0', 'spread': '73.46', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '172.81', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Baseline', 'categories': [{'measurements': [{'value': '403.3', 'spread': '80.48', 'groupId': 'OG000'}, {'value': '400.5', 'spread': '22.76', 'groupId': 'OG001'}, {'value': '416.8', 'spread': '17.46', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '419.3', 'spread': '36.58', 'groupId': 'OG000'}, {'value': '410.1', 'spread': '25.34', 'groupId': 'OG001'}, {'value': '407.3', 'spread': '13.05', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Change from Baseline to Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '16.0', 'spread': '66.51', 'groupId': 'OG000'}, {'value': '9.6', 'spread': '22.60', 'groupId': 'OG001'}, {'value': '-9.5', 'spread': '6.76', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Week 1', 'categories': [{'measurements': [{'value': '425.7', 'spread': '37.25', 'groupId': 'OG000'}, {'value': '397.3', 'spread': '30.44', 'groupId': 'OG001'}, {'value': '406.8', 'spread': '26.02', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '22.3', 'spread': '65.53', 'groupId': 'OG000'}, {'value': '-3.3', 'spread': '24.92', 'groupId': 'OG001'}, {'value': '-10.0', 'spread': '20.38', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Week 2', 'categories': [{'measurements': [{'value': '420.8', 'spread': '42.28', 'groupId': 'OG000'}, {'value': '393.3', 'spread': '28.90', 'groupId': 'OG001'}, {'value': '402.0', 'spread': '30.30', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '17.4', 'spread': '77.84', 'groupId': 'OG000'}, {'value': '-7.2', 'spread': '27.52', 'groupId': 'OG001'}, {'value': '-14.8', 'spread': '14.52', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Week 4', 'categories': [{'measurements': [{'value': '401.3', 'spread': '64.21', 'groupId': 'OG000'}, {'value': '401.8', 'spread': '27.41', 'groupId': 'OG001'}, {'value': '402.8', 'spread': '23.63', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-2.0', 'spread': '24.74', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '24.41', 'groupId': 'OG001'}, {'value': '-14.0', 'spread': '7.07', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Week 8', 'categories': [{'measurements': [{'value': '426.0', 'spread': '30.12', 'groupId': 'OG000'}, {'value': '399.6', 'spread': '27.17', 'groupId': 'OG001'}, {'value': '404.3', 'spread': '19.86', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '22.7', 'spread': '80.36', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '26.86', 'groupId': 'OG001'}, {'value': '-12.5', 'spread': '4.51', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Week 12', 'categories': [{'measurements': [{'value': '414.1', 'spread': '53.40', 'groupId': 'OG000'}, {'value': '391.4', 'spread': '42.91', 'groupId': 'OG001'}, {'value': '405.3', 'spread': '25.71', 'groupId': 'OG002'}]}]}, {'title': 'QTcF interval - Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '10.8', 'spread': '37.94', 'groupId': 'OG000'}, {'value': '-8.0', 'spread': '37.96', 'groupId': 'OG001'}, {'value': '-11.5', 'spread': '10.63', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 12', 'description': 'Values by visit from baseline and changes from baseline by post-baseline visit. The following ECG parameters were recorded: PR interval, QRS duration, QT interval, RR interval and QTcF interval.\n\nPR interval represents the time from the onset of the P wave to the start of the QRS complex. QRS duration represents the time required for a stimulus to spread through the ventricles (ventricular depolarization). QT interval represents the time from the start of the Q wave to the end of the T wave. RR interval represents the time from the onset of one R wave to the onset of the next one, one complete cardiac cycle. QT corrected for heart rate (QTc) interval reflects ventricular repolarization.', 'unitOfMeasure': 'milliseconds (ms)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety set (SS) was defined as all randomized participants who had taken at least 1 dose of study medication. The participants in the SS were to be analyzed based on the treatment they received, regardless of randomization'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Serum Iron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23.81', 'spread': '13.438', 'groupId': 'OG000'}, {'value': '28.42', 'spread': '9.796', 'groupId': 'OG001'}, {'value': '30.88', 'spread': '13.329', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '12.54', 'spread': '9.159', 'groupId': 'OG000'}, {'value': '11.38', 'spread': '7.693', 'groupId': 'OG001'}, {'value': '28.20', 'spread': '17.919', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baselines to Week 1', 'categories': [{'measurements': [{'value': '-11.27', 'spread': '7.158', 'groupId': 'OG000'}, {'value': '-17.03', 'spread': '9.611', 'groupId': 'OG001'}, {'value': '-2.68', 'spread': '12.365', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '11.71', 'spread': '8.622', 'groupId': 'OG000'}, {'value': '12.99', 'spread': '8.978', 'groupId': 'OG001'}, {'value': '32.48', 'spread': '15.541', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '-9.74', 'spread': '4.707', 'groupId': 'OG000'}, {'value': '-15.43', 'spread': '12.784', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '3.996', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '13.90', 'spread': '12.222', 'groupId': 'OG000'}, {'value': '12.85', 'spread': '7.583', 'groupId': 'OG001'}, {'value': '31.08', 'spread': '13.721', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-9.33', 'spread': '4.659', 'groupId': 'OG000'}, {'value': '-14.03', 'spread': '8.432', 'groupId': 'OG001'}, {'value': '0.20', 'spread': '2.902', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '11.35', 'spread': '7.822', 'groupId': 'OG000'}, {'value': '11.55', 'spread': '9.651', 'groupId': 'OG001'}, {'value': '26.70', 'spread': '12.040', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-11.88', 'spread': '9.627', 'groupId': 'OG000'}, {'value': '-17.05', 'spread': '11.936', 'groupId': 'OG001'}, {'value': '-0.37', 'spread': '3.550', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '13.72', 'spread': '11.031', 'groupId': 'OG000'}, {'value': '11.62', 'spread': '6.442', 'groupId': 'OG001'}, {'value': '27.10', 'spread': '12.856', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-10.54', 'spread': '6.782', 'groupId': 'OG000'}, {'value': '-16.22', 'spread': '10.892', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '2.701', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 12', 'description': "Assessment of total serum Iron from baseline over a 12-week period (absolute and change from baseline).\n\nFor the serum iron parameter, the 'Baseline' was collected during the screening period within the biochemistry sample.", 'unitOfMeasure': 'Micromoles per Litre (umol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '403.14', 'spread': '226.315', 'groupId': 'OG000'}, {'value': '1133.23', 'spread': '2119.115', 'groupId': 'OG001'}, {'value': '440.03', 'spread': '321.453', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '416.76', 'spread': '220.567', 'groupId': 'OG000'}, {'value': '471.53', 'spread': '209.800', 'groupId': 'OG001'}, {'value': '445.80', 'spread': '228.244', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '-10.14', 'spread': '31.509', 'groupId': 'OG000'}, {'value': '40.89', 'spread': '164.466', 'groupId': 'OG001'}, {'value': '5.77', 'spread': '93.946', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '441.34', 'spread': '269.599', 'groupId': 'OG000'}, {'value': '500.79', 'spread': '230.076', 'groupId': 'OG001'}, {'value': '411.35', 'spread': '207.477', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '3.29', 'spread': '60.579', 'groupId': 'OG000'}, {'value': '23.80', 'spread': '149.147', 'groupId': 'OG001'}, {'value': '-49.80', 'spread': '76.867', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '476.60', 'spread': '282.457', 'groupId': 'OG000'}, {'value': '585.71', 'spread': '311.224', 'groupId': 'OG001'}, {'value': '389.83', 'spread': '240.553', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '1.05', 'spread': '61.638', 'groupId': 'OG000'}, {'value': '89.98', 'spread': '249.397', 'groupId': 'OG001'}, {'value': '-50.20', 'spread': '80.958', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '463.67', 'spread': '206.646', 'groupId': 'OG000'}, {'value': '508.56', 'spread': '211.366', 'groupId': 'OG001'}, {'value': '340.23', 'spread': '165.356', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-11.88', 'spread': '43.063', 'groupId': 'OG000'}, {'value': '52.84', 'spread': '157.952', 'groupId': 'OG001'}, {'value': '-9.45', 'spread': '20.577', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '465.72', 'spread': '227.378', 'groupId': 'OG000'}, {'value': '927.42', 'spread': '1478.471', 'groupId': 'OG001'}, {'value': '261.70', 'spread': '53.033', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-15.84', 'spread': '66.208', 'groupId': 'OG000'}, {'value': '-139.23', 'spread': '626.380', 'groupId': 'OG001'}, {'value': '7.25', 'spread': '57.205', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 12', 'description': "Assessment of serum ferritin from baseline over a 12-week period (absolute and change from baseline).\n\nFor the serum ferritin parameter, the 'Baseline' was collected during the screening period within the biochemistry sample.", 'unitOfMeasure': 'Microgrammes per Litre (ug/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Transferrin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'classes': [{'title': 'Baseline 2h post-dose', 'categories': [{'measurements': [{'value': '1.601', 'spread': '0.4377', 'groupId': 'OG000'}, {'value': '1.673', 'spread': '0.3177', 'groupId': 'OG001'}, {'value': '1.655', 'spread': '0.3003', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.610', 'spread': '0.4557', 'groupId': 'OG000'}, {'value': '1.822', 'spread': '0.3903', 'groupId': 'OG001'}, {'value': '1.683', 'spread': '0.2210', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 1', 'categories': [{'measurements': [{'value': '0.009', 'spread': '0.1184', 'groupId': 'OG000'}, {'value': '0.149', 'spread': '0.1334', 'groupId': 'OG001'}, {'value': '0.028', 'spread': '0.2419', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.601', 'spread': '0.5043', 'groupId': 'OG000'}, {'value': '1.759', 'spread': '0.3569', 'groupId': 'OG001'}, {'value': '1.655', 'spread': '0.2408', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '-0.014', 'spread': '0.1516', 'groupId': 'OG000'}, {'value': '0.087', 'spread': '0.1429', 'groupId': 'OG001'}, {'value': '0.000', 'spread': '0.1846', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.708', 'spread': '0.2672', 'groupId': 'OG000'}, {'value': '1.705', 'spread': '0.3496', 'groupId': 'OG001'}, {'value': '1.745', 'spread': '0.3756', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '0.053', 'spread': '0.2014', 'groupId': 'OG000'}, {'value': '0.054', 'spread': '0.1535', 'groupId': 'OG001'}, {'value': '0.090', 'spread': '0.2740', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '1.640', 'spread': '0.2745', 'groupId': 'OG000'}, {'value': '1.725', 'spread': '0.3194', 'groupId': 'OG001'}, {'value': '1.553', 'spread': '0.2836', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-0.015', 'spread': '0.0675', 'groupId': 'OG000'}, {'value': '0.093', 'spread': '0.1618', 'groupId': 'OG001'}, {'value': '-0.120', 'spread': '0.0854', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '1.706', 'spread': '0.1954', 'groupId': 'OG000'}, {'value': '1.656', 'spread': '0.2974', 'groupId': 'OG001'}, {'value': '1.610', 'spread': '0.4784', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-0.040', 'spread': '0.1116', 'groupId': 'OG000'}, {'value': '0.100', 'spread': '0.1044', 'groupId': 'OG001'}, {'value': '-0.063', 'spread': '0.1266', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 12', 'description': 'Assessment of serum transferrin from baseline over a 12-week period (absolute and change from baseline).\n\nFor the serum transferrin parameter, the "Baseline 2h post-dose" was defined as the value at Visit 3 2h post-dose.', 'unitOfMeasure': 'Grammes per Litre (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Calculated Transferrin Saturation (TSAT) )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '69.3', 'spread': '31.16', 'groupId': 'OG000'}, {'value': '79.0', 'spread': '24.05', 'groupId': 'OG001'}, {'value': '83.3', 'spread': '33.50', 'groupId': 'OG002'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '36.8', 'spread': '24.44', 'groupId': 'OG000'}, {'value': '32.2', 'spread': '21.44', 'groupId': 'OG001'}, {'value': '56.5', 'spread': '30.56', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baselone to Week 1', 'categories': [{'measurements': [{'value': '-32.6', 'spread': '19.55', 'groupId': 'OG000'}, {'value': '-46.8', 'spread': '22.55', 'groupId': 'OG001'}, {'value': '-26.8', 'spread': '28.77', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '36.0', 'spread': '22.81', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '24.13', 'groupId': 'OG001'}, {'value': '71.5', 'spread': '33.91', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 2', 'categories': [{'measurements': [{'value': '-29.5', 'spread': '14.57', 'groupId': 'OG000'}, {'value': '-43.2', 'spread': '33.23', 'groupId': 'OG001'}, {'value': '-11.8', 'spread': '23.50', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '41.0', 'spread': '32.27', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '24.85', 'groupId': 'OG001'}, {'value': '82.5', 'spread': '35.00', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 4', 'categories': [{'measurements': [{'value': '-24.0', 'spread': '18.21', 'groupId': 'OG000'}, {'value': '-38.7', 'spread': '27.57', 'groupId': 'OG001'}, {'value': '-0.8', 'spread': '1.50', 'groupId': 'OG002'}]}]}, {'title': 'Week 8', 'categories': [{'measurements': [{'value': '32.3', 'spread': '17.48', 'groupId': 'OG000'}, {'value': '33.5', 'spread': '27.08', 'groupId': 'OG001'}, {'value': '77.3', 'spread': '39.26', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 8', 'categories': [{'measurements': [{'value': '-32.7', 'spread': '25.80', 'groupId': 'OG000'}, {'value': '-47.9', 'spread': '29.70', 'groupId': 'OG001'}, {'value': '-0.3', 'spread': '0.58', 'groupId': 'OG002'}]}]}, {'title': 'Week 12', 'categories': [{'measurements': [{'value': '36.0', 'spread': '25.93', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '17.76', 'groupId': 'OG001'}, {'value': '76.3', 'spread': '40.99', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline to Week 12', 'categories': [{'measurements': [{'value': '-27.6', 'spread': '20.37', 'groupId': 'OG000'}, {'value': '-46.8', 'spread': '23.61', 'groupId': 'OG001'}, {'value': '-1.3', 'spread': '2.31', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From baseline to Week 12', 'description': "Assessment of TSAT from baseline over a 12-week period (absolute and change from baseline).\n\nFor the calculated transferrin saturation parameter, the 'Baseline' was collected during the screening period within the biochemistry sample.\n\nTransferrin Saturation (TSAT) was calculated as Total Iron /Total Iron Binding Capacity (TIBC) X 100.", 'unitOfMeasure': 'TSAT Percentage (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'OG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}], 'classes': [{'title': 'Visit 3 1 hour post-dose', 'categories': [{'measurements': [{'value': '796.5', 'spread': '508.2', 'groupId': 'OG000'}, {'value': '609.6', 'spread': '455.2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 3 4 hours post-dose', 'categories': [{'measurements': [{'value': '222.3', 'spread': '73.1', 'groupId': 'OG000'}, {'value': '411.0', 'spread': '269.5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 pre-dose', 'categories': [{'measurements': [{'value': '17.2', 'spread': '10.2', 'groupId': 'OG000'}, {'value': '114.4', 'spread': '78.2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 1 hour post-dose', 'categories': [{'measurements': [{'value': '986.2', 'spread': '796.7', 'groupId': 'OG000'}, {'value': '483.5', 'spread': '247.3', 'groupId': 'OG001'}]}]}, {'title': 'Visit 6 3 hours post-dose', 'categories': [{'measurements': [{'value': '578.2', 'spread': '494.5', 'groupId': 'OG000'}, {'value': '544.3', 'spread': '337.5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7 pre-dose', 'categories': [{'measurements': [{'value': '15.5', 'spread': '6.6', 'groupId': 'OG000'}, {'value': '111.0', 'spread': '61.9', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7 1 hour post-dose', 'categories': [{'measurements': [{'value': '751.7', 'spread': '682.3', 'groupId': 'OG000'}, {'value': '692.2', 'spread': '470.2', 'groupId': 'OG001'}]}]}, {'title': 'Visit 7 4 hours post-dose', 'categories': [{'measurements': [{'value': '295.5', 'spread': '209.5', 'groupId': 'OG000'}, {'value': '384.3', 'spread': '200.9', 'groupId': 'OG001'}]}]}, {'title': 'Visit 8 pre-dose', 'categories': [{'measurements': [{'value': '361.5', 'spread': '579.2', 'groupId': 'OG000'}, {'value': '136.0', 'spread': '76.8', 'groupId': 'OG001'}]}]}, {'title': 'Visit 8 1 hour post-dose', 'categories': [{'measurements': [{'value': '894.1', 'spread': '670.3', 'groupId': 'OG000'}, {'value': '650.6', 'spread': '474.5', 'groupId': 'OG001'}]}]}, {'title': 'Visit 8 3 hours post-dose', 'categories': [{'measurements': [{'value': '684.0', 'spread': '405.5', 'groupId': 'OG000'}, {'value': '569.9', 'spread': '343.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 4, Week 8 and Week 12', 'description': 'Sparse sampling for determination of VIT-2763 plasma concentration following multiple dosing was obtained from pre-dose trough to 3 hours or 4 hours post-dose at selected study visits. Pharmacokinetics parameters (Cmax, clearance, distribution volume, area under the curve (AUC) were not calculated for the study.', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) was defined as all participants who were randomized to treatment, received at least one dose of randomized treatment and had at least one post-baseline pharmacodynamic assessment. The FAS was created in accordance with the intent-to-treat principles. The participants in the FAS were to be analyzed based on the treatment that they were randomized to.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'FG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'From a total of 35 screened participants, 25 were randomized in the study. A total of 10 participants were not randomised, among which 2 participants withdrew their consent, and 8 participants did not meet the inclusion criteria.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'VIT-2763 QD', 'description': 'Participants who received VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 QD at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nThe study medication (VIT-2763 and/or matching placebo) was administered to all participants twice a day to maintain the blind.\n\nQD = once a day'}, {'id': 'BG001', 'title': 'VIT-2763 BID', 'description': 'Participants who received VIT-2763 twice a day (BID) in a total daily dose of 60 mg or 120 mg, depending on their body weight, during 12 weeks.\n\nParticipants received VIT-2763 BID at a dose of 60 mg if their body weight was between 40 kg to 59 kg or at a dose of 120 mg if their body weight was between 60 kg and 100 kg.\n\nBID = twice a day'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Participants who received twice a day hard capsules of placebo, during 12 weeks.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Greece', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'Lebanon', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Thailand', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-04-12', 'size': 31794667, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-10-14T12:18', 'hasProtocol': True}, {'date': '2021-11-29', 'size': 6054171, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-14T12:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will receive a randomisation number using a validated centralised procedure (IWRS) that automates the random assignment of treatment groups to randomisation numbers. The randomisation plan will be kept strictly confidential, accessible only to authorised persons, until the time of unblinding.\n\nThe study drugs (VIT-2763 or placebo) are provided in identical white opaque hard capsules in packaging of identical appearance.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multiple dose, multicenter, double-blind, placebo-controlled parallel group study in adult and adolescent male and female subjects with non-transfusion dependent thalassemia (NTDT)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2020-04-01', 'resultsFirstSubmitDate': '2022-10-14', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-11', 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'From baseline to Week 16', 'description': 'Please note that in this section we are presenting just the overview of the adverse events experienced by the trial participants, in particular, the number of participants with at least one TEAE. Please refer to the detailed tables included on the Adverse Event Module for specifics.'}, {'measure': 'Changes in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)', 'timeFrame': 'From baseline to Week 12', 'description': 'Summary of the values by visit from baseline and changes from baseline by post-baseline visit.'}, {'measure': 'Changes in the Heart Rate', 'timeFrame': 'From baseline to Week 12', 'description': 'Summary of the values by visit from baseline and changes from baseline by post-baseline visit.'}, {'measure': 'Changes in 12-lead Electrocardiogram (ECG) Parameters', 'timeFrame': 'From baseline to Week 12', 'description': 'Values by visit from baseline and changes from baseline by post-baseline visit. The following ECG parameters were recorded: PR interval, QRS duration, QT interval, RR interval and QTcF interval.\n\nPR interval represents the time from the onset of the P wave to the start of the QRS complex. QRS duration represents the time required for a stimulus to spread through the ventricles (ventricular depolarization). QT interval represents the time from the start of the Q wave to the end of the T wave. RR interval represents the time from the onset of one R wave to the onset of the next one, one complete cardiac cycle. QT corrected for heart rate (QTc) interval reflects ventricular repolarization.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Total Serum Iron', 'timeFrame': 'From baseline to Week 12', 'description': "Assessment of total serum Iron from baseline over a 12-week period (absolute and change from baseline).\n\nFor the serum iron parameter, the 'Baseline' was collected during the screening period within the biochemistry sample."}, {'measure': 'Change From Baseline in Serum Ferritin', 'timeFrame': 'From baseline to Week 12', 'description': "Assessment of serum ferritin from baseline over a 12-week period (absolute and change from baseline).\n\nFor the serum ferritin parameter, the 'Baseline' was collected during the screening period within the biochemistry sample."}, {'measure': 'Change From Baseline in Serum Transferrin', 'timeFrame': 'From baseline to Week 12', 'description': 'Assessment of serum transferrin from baseline over a 12-week period (absolute and change from baseline).\n\nFor the serum transferrin parameter, the "Baseline 2h post-dose" was defined as the value at Visit 3 2h post-dose.'}, {'measure': 'Change From Baseline in Calculated Transferrin Saturation (TSAT) )', 'timeFrame': 'From baseline to Week 12', 'description': "Assessment of TSAT from baseline over a 12-week period (absolute and change from baseline).\n\nFor the calculated transferrin saturation parameter, the 'Baseline' was collected during the screening period within the biochemistry sample.\n\nTransferrin Saturation (TSAT) was calculated as Total Iron /Total Iron Binding Capacity (TIBC) X 100."}, {'measure': 'Pharmacokinetics Parameters - VIT-2763 Plasma Concentration Over Time', 'timeFrame': 'Baseline, Week 4, Week 8 and Week 12', 'description': 'Sparse sampling for determination of VIT-2763 plasma concentration following multiple dosing was obtained from pre-dose trough to 3 hours or 4 hours post-dose at selected study visits. Pharmacokinetics parameters (Cmax, clearance, distribution volume, area under the curve (AUC) were not calculated for the study.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Beta-Thalassemia'], 'conditions': ['Beta-Thalassemia', 'Non-transfusion-dependent Thalassemia']}, 'referencesModule': {'references': [{'pmid': '41291806', 'type': 'DERIVED', 'citation': 'Kattamis A, Taher A, Viprakasit V, Levin C, Hermosilla R, Szecsody P, Richard F, Cappellini MD, Porter J. Safety and pharmacodynamics of the ferroportin inhibitor vamifeport in patients with non-transfusion-dependent beta-thalassemia: results from a randomized phase 2a study. Orphanet J Rare Dis. 2025 Nov 25;20(1):608. doi: 10.1186/s13023-025-04119-y.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomised, double-blind, placebo-controlled parallel group trial to investigate the safety, tolerability and efficacy of multiple doses of VIT-2763 versus placebo in participants with non-transfusion-dependent Beta-thalassemia (NTDT).', 'detailedDescription': 'The study includes a 12-week treatment period and a safety follow-up period of 4 weeks.\n\nAbout 36 participants (adults and adolescents) are expected to take part in this study at a number of different institutions internationally.\n\nAdult Participants (Cohort I) will be randomized to receive either VIT-2763 once daily (QD) or twice daily (BID) or placebo, at a dose of 120 mg or 60mg depending on their body weight. Following cohort I review, adolescent participants (Cohort II) will be randomized to the same study arms with the same interventions.\n\nThe study medication will be given as oral capsules, containing 60 mg of VIT-2763 or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of NTDT, including a β-thalassemia intermedia-phenotype.\n* NTDT is defined as subjects having received less than 5 units of red blood cells (RBCs) during the 24-week period prior to randomisation/first drug administration of VIT-2763 or placebo (Day 1; 1 unit is defined as 200 to 350 ml of transfused packed RBCs and last RBC transfusion must have been received at east 14 days prior to randomisation).\n* Male and female adult NTDT subjects, 18-65 years of age inclusive (Cohort I only) at time of screening.\n* Male and female adolescent NTDT subjects, 12-17 years of age inclusive (Cohort II only) at time of screening.\n* Subjects must have a mean baseline hemoglobin (Hb) equal to or lower than 11 g/dl, based on at least 2 consecutive measurements with at least 1 week apart within 6 weeks prior to randomisation/baseline.\n\nExclusion Criteria:\n\n* Documented diagnosis of transfusion dependent thalassemia (TDT), including a beta-thalassemia major phenotype (including β0/β0, β+/β+, β0/β+ genotype), and mixed compound heterozygous for sickling phenotype variants such as Hb S/β- thalassemia, or transfusion dependent non-deletional Hb H disease (i.e., Hb constant spring) or Hb C disease.\n* Subjects on concomitant iron chelation therapy (ICT) or subjects on prior ICT when discontinued less than 4 weeks prior randomisation. If ICT was discontinued at least 4 weeks prior randomization the subject is eligible.\n* ICT naïve subjects or subjects who discontinued ICT therapy at least 6 months before the screening visit with serum ferritin lower than 150 ng/ml and/or documented liver iron concentration (LIC) equal to or lower than 1 mg/g liver dry weight assessed through magnetic resonance imaging (MRI), or subjects on prior ICT with serum ferritin lower than 300 ng/ml and/or documented LIC lower than 3 mg/g liver dry weight assessed through MRI.\n* Subjects with transferrin saturation (TSAT) less than 30%.\n* Subjects with documented LIC greater than 15 mg/g liver dry weight assessed through MRI, or a documented myocardial T2\\* less than 20 ms, if available per local practice and retrieved within 24 months prior to randomization.\n* Adult or adolescent subjects with body weight lower than 40.0 kg or greater than 100 kg at screening.\n* Chronic liver disease and/or alanine transaminase (ALT), aspartate transaminase (AST) or gamma-glutamyl transpeptidase (GGT) above 3-fold the upper limit of normal (ULN) range at screening.\n* Estimated glomerular filtration rate (eGFR) less than 30 ml/min/1.73 m2 (according to chronic kidney disease classification Stage 4 or higher), and/or significant albuminuria greater than 30 mg/mmol. eGFR should be estimated according to Chronic Kidney Disease Epidemiology Collaboration formula (CKI-EPI) in adults, and Schwartz formula in adolescents.\n* Newly diagnosed folate deficiency anemia and/or Vitamin B12 megaloblastic anemia. Subjects with known folate deficiency anemia and/or Vitamin B12 megaloblastic anemia who are on at least 12 weeks stable replacement therapy are eligible.\n* Any history or clinically important finding of cardiac disorders, such as clinically relevant cardiac arrhythmia, cardiomyopathy, coronary disease, valve disorder, or heart failure according to New York Heart Association classification 3-4.\n* Subjects with history of partial or total splenectomy within 6 months prior to screening.'}, 'identificationModule': {'nctId': 'NCT04364269', 'acronym': 'VITHAL', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Preliminary Efficacy of VIT-2763 in β-thalassaemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'A Phase 2a, Double-blind, Randomised, Placebo-controlled, Parallel Group, Multicentre Study on Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Multiple Doses of VIT-2763 in Subjects With Non-transfusion Dependent β-thalassaemia', 'orgStudyIdInfo': {'id': 'VIT-2763-THAL-201'}, 'secondaryIdInfos': [{'id': '2019-002221-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VIT-2763 Once a day (QD)', 'description': 'Participants will be assigned to receive VIT-2763 once a day (QD) in a total daily dose of 60 mg or 120 mg depending on their body weight.\n\nThe study medication (VIT-2763 and/or matching placebo) will be administered for all participants twice a day to maintain the blind.', 'interventionNames': ['Drug: VIT-2763 once a day (QD)']}, {'type': 'EXPERIMENTAL', 'label': 'VIT-2763 Twice a day (BID)', 'description': 'Participants will be assigned to receive VIT-2763 Twice a day (BID) in a total daily dose of 60 mg or 120 mg depending on their body weight.', 'interventionNames': ['Drug: VIT-2763 twice a day (BID)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will be assigned to receive Placebo, Twice a day.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VIT-2763 once a day (QD)', 'type': 'DRUG', 'description': 'Participants will receive VIT-2763 QD at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.', 'armGroupLabels': ['VIT-2763 Once a day (QD)']}, {'name': 'VIT-2763 twice a day (BID)', 'type': 'DRUG', 'description': 'Participants will receive VIT-2763 BID at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.', 'armGroupLabels': ['VIT-2763 Twice a day (BID)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will receive hard capsules of Placebo, twice a day.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '115 27', 'city': 'Athens', 'state': 'Attica', 'country': 'Greece', 'facility': 'Clinical Site #301', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '265 04', 'city': 'Rio', 'country': 'Greece', 'facility': 'Clinical Site #302', 'geoPoint': {'lat': 38.29558, 'lon': 21.78504}}, {'zip': '54642', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Clinical Site #303', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '18411', 'city': 'Afula', 'country': 'Israel', 'facility': 'Clinical Site #401', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}, {'zip': '34362', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Clinical Site #402', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Clinical Site #403', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '20122', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Clinical Site #201', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Clinical Site #203', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '80138', 'city': 'Napoli', 'country': 'Italy', 'facility': 'Clinical Site #206', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '10043', 'city': 'Orbassano', 'country': 'Italy', 'facility': 'Clinical Site #207', 'geoPoint': {'lat': 45.00547, 'lon': 7.53813}}, {'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Clinical Site #205', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'Clinical Site #202', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '11-0236b', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Clinical Site #101', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Clinical Site #501', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Clinical Site #502', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'zip': '65000', 'city': 'Phitsanulok', 'country': 'Thailand', 'facility': 'Clinical Site #503', 'geoPoint': {'lat': 16.82481, 'lon': 100.25858}}], 'overallOfficials': [{'name': 'Clinical Research Department', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vifor (International) Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vifor (International) Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Labcorp Corporation of America Holdings, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}