Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT00110266
Status:
COMPLETED
Last Update Posted:
2021-08-16
First Post:
2005-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D019190', 'term': 'Iron Overload'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077588', 'term': 'Deferasirox'}, {'id': 'D002614', 'term': 'Chelating Agents'}, {'id': 'D003676', 'term': 'Deferoxamine'}, {'id': 'D007502', 'term': 'Iron Chelating Agents'}], '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'}, {'id': 'D064449', 'term': 'Sequestering Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D006877', 'term': 'Hydroxamic Acids'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Novartis.email@novartis.com', 'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All Adverse Event Were Collected From Start of Treatment up to 53 Weeks', 'description': 'Out of 176 participants enrolled in the study, 173 participants received study medication. As, two participants withdrew consent and one died before initiating the treatment, were not considered for this analysis.\n\nThe analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.', 'eventGroups': [{'id': 'EG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.', 'otherNumAtRisk': 173, 'deathsNumAtRisk': 173, 'otherNumAffected': 166, 'seriousNumAtRisk': 173, 'deathsNumAffected': 17, 'seriousNumAffected': 78}, {'id': 'EG001', 'title': 'Enrolled, Not Treated', 'description': 'Participant died before initiating the treatment.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stomach discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Transfusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'International normalised ratio increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, 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3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Lymphorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 53 Weeks', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the study, whether or not considered related to the participant's participation in the study. Serious Adverse Events include adverse events that result in either of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change in Serum Ferritin From Baseline to Weeks 13, 25, 37 and 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2771.5', 'groupId': 'OG000', 'lowerLimit': '863', 'upperLimit': '9993'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-146.5', 'groupId': 'OG000', 'lowerLimit': '-6679', 'upperLimit': '3260'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-167.5', 'groupId': 'OG000', 'lowerLimit': '-5034', 'upperLimit': '2265'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-505.0', 'groupId': 'OG000', 'lowerLimit': '-3699', 'upperLimit': '4132'}]}]}, {'title': 'Week 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-592.0', 'groupId': 'OG000', 'lowerLimit': '-5752', 'upperLimit': '5948'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Weeks 13, 25, 37 and 53', 'description': 'Change in levels of serum ferritin from baseline to 3, 6, 9 and 12 months (Weeks 13, 25, 37 and 53).', 'unitOfMeasure': 'μg/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) populations consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change in Labile Plasma Iron (LPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.30', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.6'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'groupId': 'OG000', 'lowerLimit': '-3.3', 'upperLimit': '2.2'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.20', 'groupId': 'OG000', 'lowerLimit': '-2.4', 'upperLimit': '1.2'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'groupId': 'OG000', 'lowerLimit': '-3.4', 'upperLimit': '0.6'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.45', 'groupId': 'OG000', 'lowerLimit': '-3.6', 'upperLimit': '0.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Weeks 13, 25, 37 and 49', 'description': 'LPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The blood sample for LPI determinations was collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49. LPI was calculated as 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe', 'unitOfMeasure': 'LPI Unit', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set populations consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Directly Chelatable Iron (DCI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.5', 'upperLimit': '2.2'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '2.6'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1.4'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-0.6', 'upperLimit': '1.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Weeks 13, 25, 37 and 49', 'description': 'The blood sample for DCI determinations were collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49.', 'unitOfMeasure': 'µM', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set populations consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Total Iron Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '194.0', 'groupId': 'OG000', 'lowerLimit': '48.0', 'upperLimit': '409.0'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '230.50', 'groupId': 'OG000', 'lowerLimit': '54.0', 'upperLimit': '863.0'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '222.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '497.0'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '212.0', 'groupId': 'OG000', 'lowerLimit': '53.0', 'upperLimit': '480.0'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '218.0', 'groupId': 'OG000', 'lowerLimit': '48.0', 'upperLimit': '929.0'}]}]}, {'title': 'Week 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '221.00', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '455.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Weeks 13, 25, 37, 49 and 53', 'description': 'Levels of non-transferrin bound iron (NTBI) and serum iron from baseline to 3,6,9 and 12 months (Weeks 13, 25, 37 and 49) were assessed.', 'unitOfMeasure': 'μg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set populations consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Serum Transferrin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '156.0', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '244.0'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '161.0', 'groupId': 'OG000', 'lowerLimit': '108.0', 'upperLimit': '257.0'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '160.0', 'groupId': 'OG000', 'lowerLimit': '107.0', 'upperLimit': '266.0'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '158.0', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '272.0'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '160.0', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '289.0'}]}]}, {'title': 'Week 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '90', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '161.00', 'groupId': 'OG000', 'lowerLimit': '99.0', 'upperLimit': '253.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Weeks 13, 25, 37, 49 and 53', 'description': 'Serum transferrin from baseline to 3, 6, 9 and 12 months of treatment (Visit Weeks 13, 25, 37 and 49) were assessed.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set populations consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Transferrin Saturation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.00', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '94.0'}]}]}, {'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.00', 'groupId': 'OG000', 'lowerLimit': '-73.0', 'upperLimit': '57.0'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-11.00', 'groupId': 'OG000', 'lowerLimit': '-66.0', 'upperLimit': '58.0'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.50', 'groupId': 'OG000', 'lowerLimit': '-68.0', 'upperLimit': '57.0'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.00', 'groupId': 'OG000', 'lowerLimit': '-72.0', 'upperLimit': '65.0'}]}]}, {'title': 'Week 53', 'denoms': [{'units': 'Participants', 'counts': [{'value': '89', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.00', 'groupId': 'OG000', 'lowerLimit': '-69.0', 'upperLimit': '64.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Baseline to Weeks 13, 25, 37, 49 and 53', 'description': 'Levels of transferrin saturation from baseline to 3, 6, 9 and 12 months.', 'unitOfMeasure': 'percentage of saturation', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set populations consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Transfusion Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}]}]}, {'title': 'Week 1 through 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}]}]}, {'title': 'Week 14 through 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Week 27 through 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Week 40 through 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': 'Number of participants receiving transfusions, the summarized during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set populations consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Frequency of Hematologic Improvement During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Response (Yes)', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Response (No)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': 'Hematologic responses defined by International Working Group response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks defined as:\n\nErythroid response (pretreatment, \\<11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,\\<100x10\\^9/L): If starting with \\>20x10\\^9/L platelets: absolute increase 30x10\\^9/L, Increase from baseline \\<20 x10\\^9/L to \\>20x10\\^9/L and by =/\\> 100%; Neutrophil response (pretreatment, \\<1.0x10\\^9/L): =/\\> 100% increase \\& absolute increase \\>0.5x10\\^9/L; Progression or relapse after HI: At least 1 of the following: =/\\>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on Per protocol population defined as number of participants who did not present any major deviations from protocol and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Trough Plasma Deferasirox Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'Week 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.200', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '209.0'}]}]}, {'title': 'Week 25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26.700', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '331.0'}]}]}, {'title': 'Week 37', 'denoms': [{'units': 'Participants', 'counts': [{'value': '99', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.200', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '242.0'}]}]}, {'title': 'Week 49', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.700', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '223.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At Week 13, 25, 37 and 49', 'description': 'The Pharmacokinetic (PK) parameters were assessed at Week 13, 25, 37 and 49 using Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) method.', 'unitOfMeasure': 'μmol/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set populations consisted of all participants who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Treatment Compliance to Deferasirox', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': '20 to < 40 %', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '40 - < 60 %', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '60 - < 80 %', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '80 - < 100 %', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}]}]}, {'title': '100 - < 120 %', 'categories': [{'measurements': [{'value': '65', 'groupId': 'OG000'}]}]}, {'title': '≥ 120 %', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 1 year', 'description': 'Treatment compliance was assessed using records of study medication used, dosages administered, and intervals between visits during the study. Drug accountability was noted by the field monitor during site visits and at the completion of the trial. Participants were asked to return all unused medication at monthly visits.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.'}, {'type': 'SECONDARY', 'title': 'The Prevalence of Hereditary Hemochromatosis Gene (HFE) Gene Mutations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'classes': [{'title': 'C282Y', 'categories': [{'title': 'Negative', 'measurements': [{'value': '85', 'groupId': 'OG000'}]}, {'title': 'Positive Heterozygous', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'H63D', 'categories': [{'title': 'Negative', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}, {'title': 'Positive Heterozygous', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'S65C', 'categories': [{'title': 'Negative', 'measurements': [{'value': '92', 'groupId': 'OG000'}]}, {'title': 'Positive Heterozygous', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to Week 13 (Month 3)', 'description': 'HFE (hemochromatosis) gene mutations in the Myelodysplastic Syndrome (MDS) population, the trial included testing for the C282Y, H63D and S65C HFE gene mutations. One blood sample was collected at Baseline (Week 1), or, if that visit was missing, the sample was taken at Week 13 (Month 3). Only one blood sample was to be taken from each participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 Milligrams per Kilogram per day (mg/kg/day) orally once per day (OD) for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': 'Abnormal laboratory value', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'Unsatisfactory therapeutic effect', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Participant condition no longer requires study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study was conducted at 39 centers in the United States and 6 centers in Canada', 'preAssignmentDetails': 'A total of 176 participants enrolled in the study, of these 173 participants were treated. Three of the enrolled participants were not treated as 2 withdrew the consent and 1 died even before initiating the treatment.\n\nOf the 173 treated participants, 95 completed the study and 78 discontinued treatment prematurely.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Deferasirox', 'description': 'Participants received Deferasirox 20 mg/kg/day orally OD for one year. The appropriate daily dose was calculated by participants actual body weight. Deferasirox was taken every morning 30 minutes before breakfast, preferably around the same time between 7:00 and 9:00 AM each day. The tablets was dropped into water or apple juice or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.9', 'spread': '11.45', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '103', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '159', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Oriental', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The full analysis set (FAS) population consisted of all participants who received at least 1 dose of Deferasirox.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 176}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2008-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2005-05-04', 'resultsFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2005-05-04', 'lastUpdatePostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-21', 'studyFirstPostDateStruct': {'date': '2005-05-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2008-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Adverse Events', 'timeFrame': 'up to 53 Weeks', 'description': "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the study, whether or not considered related to the participant's participation in the study. Serious Adverse Events include adverse events that result in either of death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect."}], 'secondaryOutcomes': [{'measure': 'Change in Serum Ferritin From Baseline to Weeks 13, 25, 37 and 53', 'timeFrame': 'From Baseline to Weeks 13, 25, 37 and 53', 'description': 'Change in levels of serum ferritin from baseline to 3, 6, 9 and 12 months (Weeks 13, 25, 37 and 53).'}, {'measure': 'Change in Labile Plasma Iron (LPI)', 'timeFrame': 'From Baseline to Weeks 13, 25, 37 and 49', 'description': 'LPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The blood sample for LPI determinations was collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49. LPI was calculated as 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe'}, {'measure': 'Directly Chelatable Iron (DCI)', 'timeFrame': 'From Baseline to Weeks 13, 25, 37 and 49', 'description': 'The blood sample for DCI determinations were collected at Week 1 (prior to first dose) and at Weeks 13, 25, 37 and 49.'}, {'measure': 'Total Iron Levels', 'timeFrame': 'From Baseline to Weeks 13, 25, 37, 49 and 53', 'description': 'Levels of non-transferrin bound iron (NTBI) and serum iron from baseline to 3,6,9 and 12 months (Weeks 13, 25, 37 and 49) were assessed.'}, {'measure': 'Serum Transferrin Levels', 'timeFrame': 'From Baseline to Weeks 13, 25, 37, 49 and 53', 'description': 'Serum transferrin from baseline to 3, 6, 9 and 12 months of treatment (Visit Weeks 13, 25, 37 and 49) were assessed.'}, {'measure': 'Transferrin Saturation', 'timeFrame': 'From Baseline to Weeks 13, 25, 37, 49 and 53', 'description': 'Levels of transferrin saturation from baseline to 3, 6, 9 and 12 months.'}, {'measure': 'Transfusion Requirements', 'timeFrame': 'up to 1 year', 'description': 'Number of participants receiving transfusions, the summarized during the study.'}, {'measure': 'Frequency of Hematologic Improvement During the Study', 'timeFrame': 'up to 1 year', 'description': 'Hematologic responses defined by International Working Group response criteria in myelodysplasia. Hematologic Improvement (HI) responses, at least 9 weeks defined as:\n\nErythroid response (pretreatment, \\<11 g/dL): Hgb increase by 1.5 g/dL; Relevant reduction units of Red blood cell (RBC) transfusions by absolute number at least 4 RBC transfusions/8 week compared with pretreatment transfusion number in previous 8 weeks; Only RBC transfusions for Hgb of 9.0 g/dL pretreatment count in RBC transfusion response evaluation; Platelet response (pretreatment,\\<100x10\\^9/L): If starting with \\>20x10\\^9/L platelets: absolute increase 30x10\\^9/L, Increase from baseline \\<20 x10\\^9/L to \\>20x10\\^9/L and by =/\\> 100%; Neutrophil response (pretreatment, \\<1.0x10\\^9/L): =/\\> 100% increase \\& absolute increase \\>0.5x10\\^9/L; Progression or relapse after HI: At least 1 of the following: =/\\>50% decrement from max response levels in granulocytes or platelets; Reduction in Hgb by 1.5 g/dL; or Transfusion dependence.'}, {'measure': 'Trough Plasma Deferasirox Concentration', 'timeFrame': 'At Week 13, 25, 37 and 49', 'description': 'The Pharmacokinetic (PK) parameters were assessed at Week 13, 25, 37 and 49 using Liquid Chromatography with tandem mass spectrometry (LC-MS/MS) method.'}, {'measure': 'Treatment Compliance to Deferasirox', 'timeFrame': 'up to 1 year', 'description': 'Treatment compliance was assessed using records of study medication used, dosages administered, and intervals between visits during the study. Drug accountability was noted by the field monitor during site visits and at the completion of the trial. Participants were asked to return all unused medication at monthly visits.'}, {'measure': 'The Prevalence of Hereditary Hemochromatosis Gene (HFE) Gene Mutations', 'timeFrame': 'up to Week 13 (Month 3)', 'description': 'HFE (hemochromatosis) gene mutations in the Myelodysplastic Syndrome (MDS) population, the trial included testing for the C282Y, H63D and S65C HFE gene mutations. One blood sample was collected at Baseline (Week 1), or, if that visit was missing, the sample was taken at Week 13 (Month 3). Only one blood sample was to be taken from each participant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICL670', 'Deferasirox', 'Iron chelation', 'Chelator', 'Desferal'], 'conditions': ['Myelodysplastic Syndrome', 'Iron Overload']}, 'referencesModule': {'references': [{'pmid': '22547607', 'type': 'RESULT', 'citation': 'List AF, Baer MR, Steensma DP, Raza A, Esposito J, Martinez-Lopez N, Paley C, Feigert J, Besa E. Deferasirox reduces serum ferritin and labile plasma iron in RBC transfusion-dependent patients with myelodysplastic syndrome. J Clin Oncol. 2012 Jun 10;30(17):2134-9. doi: 10.1200/JCO.2010.34.1222. Epub 2012 Apr 30.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2782', 'label': 'Results for CICL670AUS03 from the Novartis Clinical Trials website'}, {'url': 'http://ascopubs.org/doi/pdf/10.1200/JCO.2010.34.1222', 'label': 'Publication (Embasse # 2012421150)'}, {'url': 'https://www.ncbi.nlm.nih.gov/pubmed/?term=22547607', 'label': 'Publication (Embasse # 2012421150)'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.', 'detailedDescription': 'Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least three complete blood count (CBC) values must be available for the 12 weeks prior to study registration for patients with MDS and chronic iron overload from blood transfusions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients with low or intermediate (INT-1) risk MDS\n* Patients can be EITHER naïve to iron chelation OR have had prior treatment with deferoxamine (DFO).\n* Age greater than or equal to 18 years\n* Availability of transfusion records for the 12 weeks prior to registration\n* A lifetime minimum of 30 previous packed red blood cell transfusions\n* Availability of at least three CBC values (pretransfusion) during the 12 weeks prior to registration\n* Serum Ferritin:\n\nFor entry into the screening period, serum ferritin ≥ 1000 ng/mL on at least two occasions, at least two weeks apart, during the prior year.\n\nSerum ferritin ≥ 1000 ng/mL at screening via the central lab.\n\n* Life expectancy ≥ 6 months\n* Sexually active women must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined as amenorrhea for at least 12 months)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Serum creatinine above the upper limit of normal\n* Alanine aminotransferase (ALT) \\> 500 U/L during screening\n* Clinical or laboratory evidence of active Hepatitis B or C\n* Urinary protein/creatinine ratio \\> 0.5 mg/mg\n* History of HIV positive test result (ELISA or Western blot)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status \\> 2\n* Patients with uncontrolled systemic hypertension\n* Unstable cardiac disease not controlled by standard medical therapy\n* Patients with a diagnosis of or history of clinically relevant ocular toxicity related to iron chelation\n* Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment\n* Pregnancy or breast feeding\n* Treatment with systemic investigational drug within the past 4 weeks or topical investigational drug within the past 7 days\n* Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of study drug\n* History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative'}, 'identificationModule': {'nctId': 'NCT00110266', 'briefTitle': 'Study of Deferasirox for Treatment of Transfusional Iron Overload in Myelodysplastic Patients', 'nctIdAliases': ['NCT00343837'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-risk and INT-1, Myelodysplastic Patients Using Serum Ferritin Monitoring', 'orgStudyIdInfo': {'id': 'CICL670AUS03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ICL670', 'description': 'Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS', 'interventionNames': ['Drug: Deferasirox']}], 'interventions': [{'name': 'Deferasirox', 'type': 'DRUG', 'otherNames': ['ICL670A', 'chelator', 'desferal', 'iron chelation'], 'description': '20 mg/kg/day over one year in patients with MDS', 'armGroupLabels': ['ICL670']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Univ of Alabama Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United 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'country': 'United States', 'facility': 'University of Chicago Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '40536-0093', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky College of Medicine, Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '71301', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Cabrini Center for Cancer Care/Christus St. Frances Cabrini Hospital', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '21231-1000', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'St. Agnes HealthCare', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01605', 'city': 'Worcester', 'state': 'Massachusetts', 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'facility': 'Arlington Fairfax Hematology Oncology PC', 'geoPoint': {'lat': 38.88101, 'lon': -77.10428}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5g 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}