Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-18 @ 8:59 PM
Study NCT ID:
NCT02435212
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2015-03-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'Denmark']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019190', 'term': 'Iron Overload'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010549', 'term': 'Personal Satisfaction'}], 'ancestors': [{'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077588', 'term': 'Deferasirox'}], 'ancestors': [{'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'novartis.email@novartis.com', 'phone': '+1 862 778 8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From initial randomization up to 48 weeks (Core phase) and Up to 5 years from entering the extension phase (Optional Extension phase)', 'description': 'The Safety Set consisted of all participants who received at least 1 dose of granule formulation during the core or extension phase. The participants in extension phase received granules regardless of which arm they were initially randomized. Three participants did not receive the study drug and hence were excluded from the safety set.', 'eventGroups': [{'id': 'EG000', 'title': 'DFX DT- Core Phase', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations.', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 104, 'seriousNumAtRisk': 111, 'deathsNumAffected': 0, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'DFX DT Cross-over Granule - Optional Extension Phase', 'description': 'After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 63, 'seriousNumAtRisk': 69, 'deathsNumAffected': 1, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'DFX Granules - Core Phase', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 97, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 27}, {'id': 'EG003', 'title': 'DFX Granules - Optional Extension Phase', 'description': 'After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.', 'otherNumAtRisk': 77, 'deathsNumAtRisk': 77, 'otherNumAffected': 63, 'seriousNumAtRisk': 77, 'deathsNumAffected': 0, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Systemic viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 31}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Bilirubin conjugated increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Urine protein/creatinine ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 9}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Hypersplenism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 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'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Craniofacial fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Febrile nonhaemolytic transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Lip injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Urine protein/creatinine ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Lactase deficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Fanconi syndrome acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Acute chest syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Obstructive sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Tonsillar hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Drug reaction with eosinophilia and systemic symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 69, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 77, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (26.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Overall Compliance Using Stick Pack or Tablet Counts in Iron Chelation Therapy (ICT)-naïve Participants During the Core Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '89.45', 'groupId': 'OG000', 'lowerLimit': '85.29', 'upperLimit': '93.61'}, {'value': '91.78', 'groupId': 'OG001', 'lowerLimit': '87.81', 'upperLimit': '95.75'}]}]}], 'analyses': [{'pValue': '0.3598', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.58', 'ciLowerLimit': '-2.99', 'ciUpperLimit': '8.15', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.803', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'Compliance was calculated as the ratio of total count consumed to total count prescribed of deferasirox granule stick packs or dispersible tablets, where total count consumed was derived from cumulative dispensed, returned and lost/wasted counts over 24 weeks of treatment and total count prescribed was derived from cumulative prescribed count over 24 weeks of treatment.', 'unitOfMeasure': 'percentage of compliance', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 1 (FAS-1) consisted of all ICT naive randomized participants during the core phase.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in ICT naïve Participants During the Core Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2063.7', 'groupId': 'OG000', 'lowerLimit': '1807.17', 'upperLimit': '2320.15'}, {'value': '1955.5', 'groupId': 'OG001', 'lowerLimit': '1712.57', 'upperLimit': '2198.49'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2216.3', 'groupId': 'OG000', 'lowerLimit': '1929.59', 'upperLimit': '2502.93'}, {'value': '2228.4', 'groupId': 'OG001', 'lowerLimit': '2011.69', 'upperLimit': '2445.18'}]}]}, {'title': 'Change from Baseline to Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '250.5', 'groupId': 'OG000', 'lowerLimit': '-84.63', 'upperLimit': '585.58'}, {'value': '340.0', 'groupId': 'OG001', 'lowerLimit': '115.48', 'upperLimit': '564.59'}]}]}], 'analyses': [{'pValue': '0.2546', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '176.36', 'ciLowerLimit': '-129.00', 'ciUpperLimit': '481.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '153.933', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 25', 'description': 'The analysis included the comparison of means between the two treatment arms of change from baseline after 24 weeks of treatment in serum ferritin in pediatric ICT naïve participants with iron overload. The endpoint was assessed at Week 25 visit.', 'unitOfMeasure': 'μg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 1 (FAS-1) consisted of all ICT naive randomized participants during the core phase.'}, {'type': 'SECONDARY', 'title': 'Percentage of Overall Compliance Using Stick Pack or Tablet Counts in ICT-naïve Participants During the Core Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '91.57', 'groupId': 'OG000', 'lowerLimit': '87.65', 'upperLimit': '95.49'}, {'value': '94.80', 'groupId': 'OG001', 'lowerLimit': '91.48', 'upperLimit': '98.13'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 weeks', 'description': 'Compliance was calculated as the ratio of total count consumed to total count prescribed of deferasirox granule stick packs or dispersible tablets over 48 weeks of treatment.', 'unitOfMeasure': 'percentage of compliance', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 1 (FAS-1) consisted of all ICT naive randomized participants during the core phase.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in ICT naïve Participants During the Core Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'categories': [{'measurements': [{'value': '305.8', 'groupId': 'OG000', 'lowerLimit': '4.28', 'upperLimit': '607.24'}, {'value': '317.0', 'groupId': 'OG001', 'lowerLimit': '69.10', 'upperLimit': '564.88'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to 48 weeks', 'description': 'The analysis included the comparison of means between the two treatment arms of change from baseline after 48 weeks of treatment in serum ferritin in pediatric ICT naïve participants with iron overload.', 'unitOfMeasure': 'μg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 1 (FAS-1) consisted of all ICT naive randomized participants during the core phase.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in Pre-treated Participants During the Core Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Change from Baseline to Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '-210.88', 'upperLimit': '328.79'}, {'value': '150.3', 'groupId': 'OG001', 'lowerLimit': '-59.43', 'upperLimit': '360.01'}]}]}, {'title': 'Change from Baseline to Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '207.7', 'groupId': 'OG000', 'lowerLimit': '-94.29', 'upperLimit': '509.68'}, {'value': '215.7', 'groupId': 'OG001', 'lowerLimit': '-50.47', 'upperLimit': '481.95'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Baseline to Week 25 and Week 48', 'description': 'The analysis included the comparison of means between the two treatment arms of change from baseline after 25 weeks and after 48 weeks of treatment in serum ferritin in pre-treated participants. The analyses were performed at Week 25 and Week 48.', 'unitOfMeasure': 'μg/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 2 (FAS-2) consisted of all ICT pre-treated randomized participants during the core phase.'}, {'type': 'SECONDARY', 'title': 'Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Patient Reported Outcomes (PRO) Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Adherence (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '7.6', 'spread': '1.99', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '6.6', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.9', 'spread': '3.93', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '3.31', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '4.17', 'groupId': 'OG000'}, {'value': '8.4', 'spread': '2.29', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction/preference (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '2.09', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '1.36', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction/preference (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.22', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction/preference (Week 25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.10', 'groupId': 'OG001'}]}]}, {'title': 'Satisfaction/preference (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'spread': '2.24', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '0.92', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '2.18', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '1.06', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.4', 'spread': '2.10', 'groupId': 'OG000'}, {'value': '14.4', 'spread': '0.80', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '1.21', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '2.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': 'Participants aged between 10 years and less than 18 years at enrollment completed PRO questionnaires by themselves. The mSICT questionnaire for PRO consisted of 3 domains: adherence, satisfaction/preference, and concerns. The adherence domain had a minimum score of 6 and maximum score of 30; a lower score for adherence indicates better adherence. Satisfaction/preference domain had a minimum score of 2 and maximum score of 10; a lower score for satisfaction/preference indicates better satisfaction/preference. Concerns domain had a minimum score of 3 and maximum score of 15; a higher score for concerns indicate fewer concerns.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 10 years and less than 18 years with a valid assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Observer Reported Outcomes (ObsRO) Questionnaire (Caregiver's Perspective)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Adherence (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.7', 'spread': '2.84', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.32', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.8', 'spread': '2.64', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '1.43', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.35', 'groupId': 'OG000'}, {'value': '6.5', 'spread': '1.69', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '2.53', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.57', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.31', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '0.89', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '0.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': "The ObsRO questionnaires for participants aged between 2 years and less than 10 years were designed as observations made by caregivers such as the parent or legal guardian. The caregivers continued completing the ObsRO questionnaires even after the participant turned 10 years for consistency in responses. The mSICT questionnaire consisted of 2 domains: adherence and concerns per caregiver's perspective. The adherence domain had a minimum score of 5 and a maximum score of 25; a lower score for adherence indicates better adherence. The concerns domain had a minimum score of 1 and a maximum score of 5; a higher score for concerns indicates fewer concerns.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 2 years and less than 10 years with a valid assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Observer Reported Outcomes (ObsRO) Questionnaire (Child's Perspective)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Adherence (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.1', 'spread': '4.57', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.28', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.7', 'spread': '3.78', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'spread': '3.82', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '2.64', 'groupId': 'OG001'}]}]}, {'title': 'Adherence (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.3', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '3.00', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '2.29', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '1.66', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '2.00', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '2.04', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '1.94', 'groupId': 'OG000'}, {'value': '8.7', 'spread': '1.85', 'groupId': 'OG001'}]}]}, {'title': 'Concerns (Week 48)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '1.75', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '1.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': "The ObsRO questionnaires for participants aged between 2 years and less than 10 years were designed as observations made by caregivers such as the parent or legal guardian. The caregivers continued completing the ObsRO questionnaires even after the participant turned 10 years for consistency in responses. The mSICT questionnaire is presented for 2 domains: adherence and concerns per child's perspective. The adherence domain had a minimum score of 6 and a maximum score of 30; a lower score for adherence indicates better adherence. The concerns domain had a minimum score of 2 and a maximum score of 10; a higher score for concerns indicates fewer concerns.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 2 years and less than 10 years with a valid assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change Over-time in Domain Score of Palatability Using Patient Reported Outcomes (PRO) Questionnaires', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '3.32', 'groupId': 'OG000'}, {'value': '10.3', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.6', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '0.24', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '1.80', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '11.0', 'spread': '0.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': 'The palatability questionnaire was used to measure: taste, aftertaste, whether medication was taken and how the participant perceived the amount of medication taken. This questionnaire had a minimum score of 0 and maximum score of 11; a higher score means better palatability. Participants aged between 10 years and less than 18 years at enrollment completed the PRO questionnaire by themselves.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 10 years and less than 18 years with a valid assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change Over-time in Domain Score of Palatability Using Observer Reported Outcomes (ObsRO) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '0.90', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.4', 'spread': '2.88', 'groupId': 'OG000'}, {'value': '10.8', 'spread': '0.79', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '1.73', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.0', 'spread': '3.11', 'groupId': 'OG000'}, {'value': '10.9', 'spread': '0.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': 'The palatability questionnaire was used to measure: taste, aftertaste, whether medication was taken and how the participant perceived the amount of medication taken. This questionnaire had a minimum score of 0 and maximum score of 11; a higher score means better palatability. The ObsRO questionnaires for participants aged between 2 years and less than 10 years were designed as observations made by caregivers such as the parent or legal guardian. The caregivers continued completing the ObsRO questionnaires even after the participant turned 10 years for consistency in responses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 2 years and less than 10 years with a valid assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change Over Time in Weekly Dose Violation Rate Using Compliance Patient Reported Outcomes (PRO) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.86', 'spread': '37.966', 'groupId': 'OG000'}, {'value': '26.79', 'spread': '38.992', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.78', 'spread': '31.000', 'groupId': 'OG000'}, {'value': '23.41', 'spread': '35.906', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.19', 'spread': '29.614', 'groupId': 'OG000'}, {'value': '25.93', 'spread': '42.583', 'groupId': 'OG001'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.89', 'spread': '32.745', 'groupId': 'OG000'}, {'value': '30.16', 'spread': '41.921', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.86', 'spread': '7.559', 'groupId': 'OG000'}, {'value': '52.38', 'spread': '52.424', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 1, Week 13, Week 25, Week 37 and Week 48', 'description': 'The compliance questionnaire consisted of 2 items: 1. To assess if the medication was taken (yes/no) and 2. To record of the time when the medication was taken (with a not applicable option for participants who did not take their medication). Daily diary records were used to calculate the rate of dose violation in each study arm (doses missed completely or not taken before 12 PM). The dose violation rate was calculated as:\n\n\\[Number of dose violations / Drug exposure (days)\\] \\*100. Higher values represent more dose violations.', 'unitOfMeasure': 'percentage of days with dose violations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 10 years and less than 18 years with a valid assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change Over Time in Weekly Dose Violation Rate Using Compliance Observer Reported Outcomes (ObsRO) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.80', 'spread': '29.912', 'groupId': 'OG000'}, {'value': '27.79', 'spread': '37.577', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.38', 'spread': '27.374', 'groupId': 'OG000'}, {'value': '18.65', 'spread': '35.513', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.79', 'spread': '23.025', 'groupId': 'OG000'}, {'value': '13.72', 'spread': '31.813', 'groupId': 'OG001'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.86', 'spread': '31.769', 'groupId': 'OG000'}, {'value': '20.01', 'spread': '37.632', 'groupId': 'OG001'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.56', 'spread': '32.211', 'groupId': 'OG000'}, {'value': '14.50', 'spread': '31.123', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At Week 1, Week 13, Week 25, Week 37 and Week 48', 'description': 'The compliance questionnaire consisted of 2 items: 1. To assess if the medication was taken (yes/no) and 2. To record the time when the medication was taken (with a not applicable option for participants who did not take their medication). Daily diary records were used to calculate the rate of dose violation in each treatment arm (doses missed completely or not taken before 12 PM). The ObsRO questionnaires for participants aged between 2 years and less than 10 years were designed as observations made by caregivers such as the parent or legal guardian. The caregivers continued completing the ObsRO questionnaires even after the participant turned 10 years for consistency in responses. The dose violation rate was calculated as: \\[Number of dose violations / Drug exposure (days)\\] \\*100.\n\nHigher values represent more dose violations.', 'unitOfMeasure': 'percentage of days with dose violations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set 3 (FAS-3) consisted of all randomized participants during the core phase. This includes only the participants aged between 2 years and less than 10 years with a valid assessment for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Core Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT - Core Phase', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations.'}, {'id': 'OG001', 'title': 'DFX Granule - Core Phase', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations.'}], 'classes': [{'title': 'All AEs', 'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'All SAEs', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to 48 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all participants who received at least 1 dose of study drug during the core phase. Three participants did not receive the study drug and hence were excluded from the safety set.'}, {'type': 'SECONDARY', 'title': 'Pre-dose Concentrations of Deferasirox to Support the Assessment of Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Week 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.93', 'spread': '369.5', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '235.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.2', 'spread': '137.0', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '117.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.4', 'spread': '115.7', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '127.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.1', 'spread': '115.8', 'groupId': 'OG000'}, {'value': '12.1', 'spread': '97.1', 'groupId': 'OG001'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '124.2', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '107.5', 'groupId': 'OG001'}]}]}, {'title': 'Week 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.4', 'spread': '109.4', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '135.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.6', 'spread': '120.4', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '163.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '147.2', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '108.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.8', 'spread': '111.3', 'groupId': 'OG000'}, {'value': '13.2', 'spread': '156.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'spread': '184.0', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '175.6', 'groupId': 'OG001'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '137.1', 'groupId': 'OG000'}, {'value': '14.6', 'spread': '135.3', 'groupId': 'OG001'}]}]}, {'title': 'Week 41', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.8', 'spread': '131.6', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '134.7', 'groupId': 'OG001'}]}]}, {'title': 'Week 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.3', 'spread': '141.2', 'groupId': 'OG000'}, {'value': '19.0', 'spread': '117.0', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Weeks 1, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, and 45', 'description': "Pre-dose pharmacokinetic (PK) data from participants in the Pharmacokinetic Analysis Set 1 (PAS-1) were analyzed to assess variability of individual participant's compliance. A linear mixed effect power model to pre-dose samples which fulfill compliance criteria in terms of steady state (4 consecutive same doses prior to the PK sample drawn), time-windows (PK sample drawn 20 to 28 hours after previous dose) and without any vomiting episodes within the 4 hours prior to the PK sample were fitted. The model considered dose, treatment group, stratification factors and potential other factors, such as body weight as covariates.", 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set 1 (PAS-1) consisted of all participants who had at least one evaluable pre- or 3 hours post-dose PK concentration of deferasirox. The analysis included participants only with evaluable values.'}, {'type': 'SECONDARY', 'title': 'Concentrations of Deferasirox Between 2 and 4 Hours Post-dose at Weeks 5 and 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Week 5 (3 hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.2', 'spread': '80.5', 'groupId': 'OG000'}, {'value': '53.2', 'spread': '86.2', 'groupId': 'OG001'}]}]}, {'title': 'Week 9 (3 hour post-dose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.4', 'spread': '77.0', 'groupId': 'OG000'}, {'value': '59.8', 'spread': '61.7', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Week 5 and Week 9', 'description': 'Post-dose pharmacokinetic (PK) data from participants in the Pharmacokinetic Analysis Set 1 (PAS-1) were analyzed along with Pre-dose PK data.', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Analysis Set 1 (PAS-1) consisted of all participants who had at least one evaluable pre- or 3 hours post-dose PK concentration of deferasirox. The analysis included participants only with evaluable values.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Entire Granule Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT Cross-over Granule - Optional Extension Phase', 'description': 'After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granules - Core and Optional Extension Phase', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}]}, {'title': 'Suspected AEs', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}, {'title': 'Suspected SAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to 305 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation after participant providing written informed consent for participation in the study. In the DFX Granules arm, AEs are reported since the initial randomization to the arm in the core phase and continuing in the extension phase. In the DFX cross-over arm, AEs are reported for participants since the participant crossed-over from dispersible tablet to granules in the extension phase only.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all participants who received at least 1 dose of granule formulation during the core or extension phase. The participants in the extension phase received granules regardless of which arm they were initially randomized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events of Special Interest (AESI) During the Entire Granule Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'DFX DT Cross-over Granule - Optional Extension Phase', 'description': 'After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'OG001', 'title': 'DFX Granules - Core and Optional Extension Phase', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'classes': [{'title': 'Any AESI', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}, {'title': 'Gastrointestinal hemorrhages', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Hearing loss', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Lens opacities, Retinal changes and Optic neuritis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Liver disorders - Hepatic failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Liver disorders - Increased liver transaminases', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}, {'title': 'Peripheral blood cytopenias', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Renal disorders - Acute renal failure', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Renal disorders - Increased serum creatinine', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Renal disorders -Proteinuria', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Renal disorders - Renal tubular disorders', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Severe Cutaneous Adverse Reactions (SCARs)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline to 305 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation after participant providing written informed consent for participation in the study. In the DFX Granules arm, AEs are reported since the initial randomization to the arm in the core phase and continuing in the extension phase. In the DFX cross-over arm, AEs are reported for participants since the participant crossed-over from dispersible tablet to granules in the extension phase only. AESI included active monitoring for renal toxicity; including renal failure, hepatic toxicity; including hepatic failure, and gastrointestinal hemorrhage', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Set consisted of all participants who received at least 1 dose of granule formulation during the core or extension phase. The participants in the extension phase received granules regardless of which arm they were initially randomized.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exposure-Response Relationship in Relation to Pre- and Post-Dose Deferasirox Concentrations (PK/PD Relationship)', 'timeFrame': 'From Baseline to 48 weeks', 'description': 'This outcome measure explores exposure-response relationships for measures of safety and effectiveness through serum creatinine change from baseline, notable serum creatinine values, serum creatinine clearance change form baseline and notable serum creatinine clearance categories, serum ferritin change from baseline, in relationship to derived PK parameters for pre- and post-dose deferasirox concentrations.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'FG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}], 'periods': [{'title': 'Core Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '112'}, {'groupId': 'FG001', 'numSubjects': '112'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '87'}, {'groupId': 'FG001', 'numSubjects': '99'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Recovery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Optional Extension Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '77'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Recovery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Technical problems', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After enrollment, participants previously treated with iron chelation therapy (ICT) underwent a 5-day chelation washout period prior to the commencement of the 48-week treatment (Core phase).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'DFX DT', 'description': 'Participants received deferasirox (DFX) dispersible tablets (DT) orally once daily based on body weight for 48 weeks in the Core phase. The starting dose was 20mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and cross over to DFX granules administered orally once daily in the form of stick packs for up to 5 years. Participants entering the Optional Extension phase received the equivalent strength-adjusted DFX granules dose corresponding to the last DT dose in the Core phase taking dose adjustment guidelines into account.'}, {'id': 'BG001', 'title': 'DFX Granule', 'description': 'Participants received deferasirox (DFX) granules orally once daily based on body weight in the form of stick packs for 48 weeks in the Core phase. The starting dose was 14 mg/kg/day which was then adjusted based on tolerability, safety and efficacy considerations. After the Core phase, participants could enter the Optional Extension phase and continued receiving DFX granules at the same dose as was given at the end of the Core phase taking dose adjustment guidelines into account for up to 5 years.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'spread': '3.89', 'groupId': 'BG000'}, {'value': '5.9', 'spread': '3.94', 'groupId': 'BG001'}, {'value': '5.9', 'spread': '3.90', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '104', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set (FAS) was defined according to the Intent to Treat (ITT) principle, and included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-24', 'size': 837366, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-09T11:37', 'hasProtocol': True}, {'date': '2024-02-21', 'size': 1858700, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-09T11:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'dispFirstSubmitDate': '2018-07-16', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-02', 'studyFirstSubmitDate': '2015-03-17', 'dispFirstSubmitQcDate': '2018-07-20', 'resultsFirstSubmitDate': '2024-07-09', 'studyFirstSubmitQcDate': '2015-04-30', 'dispFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-09-02', 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exposure-Response Relationship in Relation to Pre- and Post-Dose Deferasirox Concentrations (PK/PD Relationship)', 'timeFrame': 'From Baseline to 48 weeks', 'description': 'This outcome measure explores exposure-response relationships for measures of safety and effectiveness through serum creatinine change from baseline, notable serum creatinine values, serum creatinine clearance change form baseline and notable serum creatinine clearance categories, serum ferritin change from baseline, in relationship to derived PK parameters for pre- and post-dose deferasirox concentrations.'}], 'primaryOutcomes': [{'measure': 'Percentage of Overall Compliance Using Stick Pack or Tablet Counts in Iron Chelation Therapy (ICT)-naïve Participants During the Core Phase', 'timeFrame': '24 weeks', 'description': 'Compliance was calculated as the ratio of total count consumed to total count prescribed of deferasirox granule stick packs or dispersible tablets, where total count consumed was derived from cumulative dispensed, returned and lost/wasted counts over 24 weeks of treatment and total count prescribed was derived from cumulative prescribed count over 24 weeks of treatment.'}, {'measure': 'Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in ICT naïve Participants During the Core Phase', 'timeFrame': 'From Baseline to Week 25', 'description': 'The analysis included the comparison of means between the two treatment arms of change from baseline after 24 weeks of treatment in serum ferritin in pediatric ICT naïve participants with iron overload. The endpoint was assessed at Week 25 visit.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Overall Compliance Using Stick Pack or Tablet Counts in ICT-naïve Participants During the Core Phase', 'timeFrame': '48 weeks', 'description': 'Compliance was calculated as the ratio of total count consumed to total count prescribed of deferasirox granule stick packs or dispersible tablets over 48 weeks of treatment.'}, {'measure': 'Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in ICT naïve Participants During the Core Phase', 'timeFrame': 'From Baseline to 48 weeks', 'description': 'The analysis included the comparison of means between the two treatment arms of change from baseline after 48 weeks of treatment in serum ferritin in pediatric ICT naïve participants with iron overload.'}, {'measure': 'Change From Baseline in Serum Ferritin (SF) for Both Study Drug Formulations in Pre-treated Participants During the Core Phase', 'timeFrame': 'From Baseline to Week 25 and Week 48', 'description': 'The analysis included the comparison of means between the two treatment arms of change from baseline after 25 weeks and after 48 weeks of treatment in serum ferritin in pre-treated participants. The analyses were performed at Week 25 and Week 48.'}, {'measure': 'Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Patient Reported Outcomes (PRO) Questionnaires', 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': 'Participants aged between 10 years and less than 18 years at enrollment completed PRO questionnaires by themselves. The mSICT questionnaire for PRO consisted of 3 domains: adherence, satisfaction/preference, and concerns. The adherence domain had a minimum score of 6 and maximum score of 30; a lower score for adherence indicates better adherence. Satisfaction/preference domain had a minimum score of 2 and maximum score of 10; a lower score for satisfaction/preference indicates better satisfaction/preference. Concerns domain had a minimum score of 3 and maximum score of 15; a higher score for concerns indicate fewer concerns.'}, {'measure': "Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Observer Reported Outcomes (ObsRO) Questionnaire (Caregiver's Perspective)", 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': "The ObsRO questionnaires for participants aged between 2 years and less than 10 years were designed as observations made by caregivers such as the parent or legal guardian. The caregivers continued completing the ObsRO questionnaires even after the participant turned 10 years for consistency in responses. The mSICT questionnaire consisted of 2 domains: adherence and concerns per caregiver's perspective. The adherence domain had a minimum score of 5 and a maximum score of 25; a lower score for adherence indicates better adherence. The concerns domain had a minimum score of 1 and a maximum score of 5; a higher score for concerns indicates fewer concerns."}, {'measure': "Change Over-time in Domain Score of Modified Satisfaction With Iron Chelation Therapy (mSICT) Using Observer Reported Outcomes (ObsRO) Questionnaire (Child's Perspective)", 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': "The ObsRO questionnaires for participants aged between 2 years and less than 10 years were designed as observations made by caregivers such as the parent or legal guardian. The caregivers continued completing the ObsRO questionnaires even after the participant turned 10 years for consistency in responses. The mSICT questionnaire is presented for 2 domains: adherence and concerns per child's perspective. The adherence domain had a minimum score of 6 and a maximum score of 30; a lower score for adherence indicates better adherence. The concerns domain had a minimum score of 2 and a maximum score of 10; a higher score for concerns indicates fewer concerns."}, {'measure': 'Change Over-time in Domain Score of Palatability Using Patient Reported Outcomes (PRO) Questionnaires', 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': 'The palatability questionnaire was used to measure: taste, aftertaste, whether medication was taken and how the participant perceived the amount of medication taken. This questionnaire had a minimum score of 0 and maximum score of 11; a higher score means better palatability. Participants aged between 10 years and less than 18 years at enrollment completed the PRO questionnaire by themselves.'}, {'measure': 'Change Over-time in Domain Score of Palatability Using Observer Reported Outcomes (ObsRO) Questionnaire', 'timeFrame': 'At Week 2, Week 3, Week 25 and Week 48', 'description': 'The palatability questionnaire was used to measure: taste, aftertaste, whether medication was taken and how the participant perceived the amount of medication taken. This questionnaire had a minimum score of 0 and maximum score of 11; a higher score means better palatability. The ObsRO questionnaires for participants aged between 2 years and less than 10 years were designed as observations made by caregivers such as the parent or legal guardian. The caregivers continued completing the ObsRO questionnaires even after the participant turned 10 years for consistency in responses.'}, {'measure': 'Change Over Time in Weekly Dose Violation Rate Using Compliance Patient Reported Outcomes (PRO) Questionnaire', 'timeFrame': 'At Week 1, Week 13, Week 25, Week 37 and Week 48', 'description': 'The compliance questionnaire consisted of 2 items: 1. To assess if the medication was taken (yes/no) and 2. To record of the time when the medication was taken (with a not applicable option for participants who did not take their medication). Daily diary records were used to calculate the rate of dose violation in each study arm (doses missed completely or not taken before 12 PM). The dose violation rate was calculated as:\n\n\\[Number of dose violations / Drug exposure (days)\\] \\*100. Higher values represent more dose violations.'}, {'measure': 'Change Over Time in Weekly Dose Violation Rate Using Compliance Observer Reported Outcomes (ObsRO) Questionnaire', 'timeFrame': 'At Week 1, Week 13, Week 25, Week 37 and Week 48', 'description': 'The compliance questionnaire consisted of 2 items: 1. To assess if the medication was taken (yes/no) and 2. To record the time when the medication was taken (with a not applicable option for participants who did not take their medication). Daily diary records were used to calculate the rate of dose violation in each treatment arm (doses missed completely or not taken before 12 PM). The ObsRO questionnaires for participants aged between 2 years and less than 10 years were designed as observations made by caregivers such as the parent or legal guardian. The caregivers continued completing the ObsRO questionnaires even after the participant turned 10 years for consistency in responses. The dose violation rate was calculated as: \\[Number of dose violations / Drug exposure (days)\\] \\*100.\n\nHigher values represent more dose violations.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Core Phase', 'timeFrame': 'From Baseline to 48 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study.'}, {'measure': 'Pre-dose Concentrations of Deferasirox to Support the Assessment of Compliance', 'timeFrame': 'At Weeks 1, 3, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, and 45', 'description': "Pre-dose pharmacokinetic (PK) data from participants in the Pharmacokinetic Analysis Set 1 (PAS-1) were analyzed to assess variability of individual participant's compliance. A linear mixed effect power model to pre-dose samples which fulfill compliance criteria in terms of steady state (4 consecutive same doses prior to the PK sample drawn), time-windows (PK sample drawn 20 to 28 hours after previous dose) and without any vomiting episodes within the 4 hours prior to the PK sample were fitted. The model considered dose, treatment group, stratification factors and potential other factors, such as body weight as covariates."}, {'measure': 'Concentrations of Deferasirox Between 2 and 4 Hours Post-dose at Weeks 5 and 9', 'timeFrame': 'At Week 5 and Week 9', 'description': 'Post-dose pharmacokinetic (PK) data from participants in the Pharmacokinetic Analysis Set 1 (PAS-1) were analyzed along with Pre-dose PK data.'}, {'measure': 'Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Entire Granule Period', 'timeFrame': 'From Baseline to 305 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation after participant providing written informed consent for participation in the study. In the DFX Granules arm, AEs are reported since the initial randomization to the arm in the core phase and continuing in the extension phase. In the DFX cross-over arm, AEs are reported for participants since the participant crossed-over from dispersible tablet to granules in the extension phase only.'}, {'measure': 'Number of Participants With Adverse Events of Special Interest (AESI) During the Entire Granule Period', 'timeFrame': 'From Baseline to 305 weeks', 'description': 'An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \\[including abnormal laboratory findings\\], symptom or disease) in a clinical investigation after participant providing written informed consent for participation in the study. In the DFX Granules arm, AEs are reported since the initial randomization to the arm in the core phase and continuing in the extension phase. In the DFX cross-over arm, AEs are reported for participants since the participant crossed-over from dispersible tablet to granules in the extension phase only. AESI included active monitoring for renal toxicity; including renal failure, hepatic toxicity; including hepatic failure, and gastrointestinal hemorrhage'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['New formulation', 'deferasirox', 'chelation', 'iron overload', 'compliance', 'satisfaction', 'palatability', 'PRO', 'PK', 'safety', 'PK/PD', 'ICL670'], 'conditions': ['Transfusion-dependent Anemia']}, 'descriptionModule': {'briefSummary': 'This was a randomized, open-label, multicenter, two arm, phase II study to evaluate treatment compliance and change in serum ferritin of a deferasirox granule formulation and a deferasirox dispersible tablet (DT) formulation in children and adolescents aged ≥ 2 and \\< 18 years at enrolment with any transfusion-dependent anemia requiring chelation therapy due to iron overload, to demonstrate the effect of improved compliance on iron burden.\n\nRandomization was stratified by age groups (2 to \\<10 years, 10 to \\<18 years) and prior iron chelation therapy (Yes/ No). There were two study phases which include a 1 year core phase where participants were randomized to a 48 week treatment period to either Deferasirox DT or granules, and an optional extension phase where all participants received the granules up to 5 years. Participants who demonstrated benefit to granules or DT in the core phase, and/or expressed the wish to continue in the optional extension phase on granules, were offered this possibility until there was local access to the new formulation (granules or film-coated tablet (FCT)) or up to 5 years, whichever occurred first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent/assent before any study-specific procedures. Consent will be obtained from parent(s) or legal guardians. Investigators will also obtain assent of patients according to local guidelines.\n* Male and female children and adolescents aged ≥ 2 and \\< 18 years. \\[France: Male and female children and adolescent aged ≥ 2 and \\< 18 years old, however children aged ≥ 2 and ≤ 6years can be enrolled only when deferoxamine treatment is contraindicated or inadequate in these patients as per investigator decision. Applicable to core phase only. Once in the core phase patients can turn 18 years and still be considered eligible, also for participation in the optional extension phase.\n* Any transfusion-dependent anemia associated with iron overload requiring iron chelation therapy and with a history of transfusion of approximately 20 PRBC units and a treatment goal to reduce iron burden (300mL PRBC = 1 unit in adults whereas 4 ml/kg PRBC is considered 1 unit for children).\n* Serum ferritin \\> 1000 ng/mL, measured at screening Visit 1 and screening Visit 2 (the mean value will be used for eligibility criteria).\n* Patient has to have participated and completed the 48 weeks core phase treatment as per protocol (For optional extension phase eligibility only).\n\nExclusion Criteria:\n\n* Creatinine clearance below the contraindication limit in the locally approved prescribing information (using Schwartz formula) at screening visit 1 or screening visit 2.\n* Serum creatinine \\> 1.5 xULN at screening measured at screening Visit 1 and or screening Visit 2\n* ALT and/or AST \\> 3.0 x ULN at screening visit 1 or screening visit 2..\n* Liver disease with severity of Child-Pugh class B or C.\n* Significant proteinuria as indicated by a urinary protein/creatinine ratio \\> 0.5 mg/mg in a second morning urine sample at screening Visit 1 or screening Visit 2.\n* Patients with significant impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox (e.g. ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).\n* Direct (conjugated) bilirubin \\>2 x ULN at screening visit 1 or screening visit 2.\n* Local access to new formulation (granules or FCT) is available (For optional extension phase eligibility only).'}, 'identificationModule': {'nctId': 'NCT02435212', 'briefTitle': 'Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients (2-<18 Years Old) With Iron Overload', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Open-label, Multicenter, Two Arm, Phase II Study to Evaluate Treatment Compliance, Efficacy and Safety of an Improved Deferasirox Formulation (Granules) in Pediatric Patients With Iron Overload', 'orgStudyIdInfo': {'id': 'CICL670F2202'}, 'secondaryIdInfos': [{'id': '2013-004739-55', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'DFX DT', 'description': 'Participants will be administered deferasirox dispersible tablets orally once daily based on body weight for 48 weeks.', 'interventionNames': ['Drug: Deferasirox DT formulation']}, {'type': 'EXPERIMENTAL', 'label': 'DFX Granule', 'description': 'Participants will be administered deferasirox granules orally once daily in the form of stick packs based on body weight for 48 weeks.', 'interventionNames': ['Drug: Deferasirox granule formulation']}], 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