Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-25 @ 2:59 PM
Study NCT ID:
NCT00828750
Status:
COMPLETED
Last Update Posted:
2018-09-17
First Post:
2009-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C520809', 'term': 'eltrombopag'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) and serious adverse events (SAEs) with an onset on or after the start date of study medication were collected until the end of the study (up to 981 days).', 'eventGroups': [{'id': 'EG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.", 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 19, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Parotitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tinea infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dental caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Food poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis atrophic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Reflux oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tongue discolouration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Asthenopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Conjunctivitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Tenosynovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Periarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Heat rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Seborrhoeic dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lip injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Glucose urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Metabolic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Genital haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Uterine prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Presbyacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lip neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'seriousEvents': [{'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Mallory-Weiss syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Spinal osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Cystitis-like symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Drug-Related AE', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'AE Leading to Withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'SAE Leading to Withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Ongoing AE at the End of Study/Withdrawal', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Mild AE', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Moderate AE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Severe AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)', 'description': "An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population (SP): all participants who received at least one dose of study medication'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'classes': [{'title': 'Baseline, n=19', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 1, n=19', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 2, n=19', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 3, n=19', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, n=19', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, n=19', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, n=16', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, n=17', 'categories': [{'measurements': [{'value': '76.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, n=15', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, n=17', 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, n=16', 'categories': [{'measurements': [{'value': '81.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, n=16', 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 36, n=18', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, n=17', 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 44, n=17', 'categories': [{'measurements': [{'value': '58.8', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, n=18', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}, {'title': 'Week 52, n=16', 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 56, n=14', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 60, n=16', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 64, n=14', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 68, n=14', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 72, n=12', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 76, n=12', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 80, n=12', 'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 84, n=13', 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 88, n=12', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 92, n=11', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, n=11', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 100, n=13', 'categories': [{'measurements': [{'value': '46.2', 'groupId': 'OG000'}]}]}, {'title': 'Week 104, n=11', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}]}]}, {'title': 'Week 108, n=11', 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 112, n=7', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}]}]}, {'title': 'Week 116, n=7', 'categories': [{'measurements': [{'value': '85.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 120, n=5', 'categories': [{'measurements': [{'value': '40.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 124, n=6', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}]}]}, {'title': 'Week 128, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 132, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Week 136, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Last Visit/Early Withdrawal Visit, n=19', 'categories': [{'measurements': [{'value': '57.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)', 'description': 'Platelet counts were measured by blood draw.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all participants with the exception of those who did not receive any dose of study medication and those with no valid measurements of platelet count on therapy. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.'}, {'type': 'SECONDARY', 'title': 'Median Platelet Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'classes': [{'title': 'Baseline, n=19', 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '117'}]}]}, {'title': 'Week 1, n=19', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '308'}]}]}, {'title': 'Week 2, n=19', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '463'}]}]}, {'title': 'Week 3, n=19', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '194'}]}]}, {'title': 'Week 4, n=19', 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '259'}]}]}, {'title': 'Week 8, n=19', 'categories': [{'measurements': [{'value': '102.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '224'}]}]}, {'title': 'Week 12, n=16', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '23', 'upperLimit': '238'}]}]}, {'title': 'Week 16, n=17', 'categories': [{'measurements': [{'value': '76.0', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '217'}]}]}, {'title': 'Week 20, n=15', 'categories': [{'measurements': [{'value': '61.0', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '252'}]}]}, {'title': 'Week 24, n=17', 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '255'}]}]}, {'title': 'Week 28, n=16', 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '17', 'upperLimit': '202'}]}]}, {'title': 'Week 32, n=16', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '184'}]}]}, {'title': 'Week 36, n=18', 'categories': [{'measurements': [{'value': '73.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '233'}]}]}, {'title': 'Week 40, n=17', 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '222'}]}]}, {'title': 'Week 44, n=17', 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '226'}]}]}, {'title': 'Week 48, n=18', 'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '224'}]}]}, {'title': 'Week 52, n=16', 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '303'}]}]}, {'title': 'Week 56, n=14', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '223'}]}]}, {'title': 'Week 60, n=16', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '252'}]}]}, {'title': 'Week 64, n=14', 'categories': [{'measurements': [{'value': '57.5', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '201'}]}]}, {'title': 'Week 68, n=14', 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '200'}]}]}, {'title': 'Week 72, n=12', 'categories': [{'measurements': [{'value': '51.5', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '188'}]}]}, {'title': 'Week 76, n=12', 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '39', 'upperLimit': '241'}]}]}, {'title': 'Week 80, n=12', 'categories': [{'measurements': [{'value': '67.5', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '277'}]}]}, {'title': 'Week 84, n=13', 'categories': [{'measurements': [{'value': '86.0', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '280'}]}]}, {'title': 'Week 88, n=12', 'categories': [{'measurements': [{'value': '65.0', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '205'}]}]}, {'title': 'Week 92, n=11', 'categories': [{'measurements': [{'value': '78.0', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '194'}]}]}, {'title': 'Week 96, n=11', 'categories': [{'measurements': [{'value': '57.0', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '236'}]}]}, {'title': 'Week 100, n=13', 'categories': [{'measurements': [{'value': '45.0', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '282'}]}]}, {'title': 'Week 104, n=11', 'categories': [{'measurements': [{'value': '44.0', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '241'}]}]}, {'title': 'Week 108, n=11', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '318'}]}]}, {'title': 'Week 112, n=7', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '146'}]}]}, {'title': 'Week 116, n=7', 'categories': [{'measurements': [{'value': '84.0', 'groupId': 'OG000', 'lowerLimit': '38', 'upperLimit': '148'}]}]}, {'title': 'Week 120, n=5', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '294'}]}]}, {'title': 'Week 124, n=6', 'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '156'}]}]}, {'title': 'Week 128, n=4', 'categories': [{'measurements': [{'value': '37.0', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '178'}]}]}, {'title': 'Week 132, n=2', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '50'}]}]}, {'title': 'Week 136, n=1', 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '51', 'upperLimit': '51'}]}]}, {'title': 'Last Visit/Early Withdrawal Visit, n=19', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '7', 'upperLimit': '314'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)', 'description': 'Platelet counts were measured by blood draw.', 'unitOfMeasure': 'Gi/L', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the measurement differs among participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'classes': [{'title': 'Study Med. =<52 weeks (WKS), MCW=0 week (WK), n=2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=1 WK, n=2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=4 WKS, n=2', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=7 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=10 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=13 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=16 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=19 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=22 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=25 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=28 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=31 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=34 WKS, n=2', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=37 WKS, n=2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=40 WKS, n=2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. =<52 WKS, MCW >=43 WKS, n=2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW=0 WK, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=1 WK, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=4 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=7 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=10 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=13 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=16 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=19 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=22 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=25 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=28 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=31 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=34 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=37 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=40 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=43 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=52 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >52 to =<78 WKS, MCW >=65 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW=0 WK, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=1 WK, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=4 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=7 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=10 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=13 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=16 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=19 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=22 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=25 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=28 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=31 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=34 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=37 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=40 WKS, n=1', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=43 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=52 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=65 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >78 to =<104 WKS, MCW >=78 WKS, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW=0 WK, n=11', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=1 WK, n=11', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=4 WKS, n=11', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=7 WKS, n=11', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=10 WKS, n=11', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=13 WKS, n=11', 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=16 WKS, n=11', 'categories': [{'measurements': [{'value': '81.8', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=19 WKS, n=11', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=22 WKS, n=11', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=25 WKS, n=11', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=28 WKS, n=11', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=31 WKS, n=11', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=34 WKS, n=11', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=37 WKS, n=11', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=40 WKS, n=11', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=43 WKS, n=11', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=52 WKS, n=11', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=65 WKS, n=11', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=78 WKS, n=11', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=91 WKS, n=11', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=104 WKS, n=11', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >104 to =<130 WKS, MCW >=117 WKS, n=6', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW=0 WK, n=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=1 WK, n=4', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=4 WKS, n=4', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=7 WKS, n=4', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=10 WKS, n=4', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=13 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=16 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=19 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=22 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=25 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=28 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=31 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=34 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=37 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=40 WKS, n=4', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=43 WKS, n=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=52 WKS, n=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=65 WKS, n=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=78 WKS, n=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=91 WKS, n=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=104 WKS, n=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Study Med. >130 WKS, MCW >=117 WKS, n=4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW=0 WK, n=19', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=1 WK, n=19', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=4 WKS, n=19', 'categories': [{'measurements': [{'value': '84.2', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=7 WKS, n=19', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=10 WKS, n=19', 'categories': [{'measurements': [{'value': '73.7', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=13 WKS, n=19', 'categories': [{'measurements': [{'value': '68.4', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=16 WKS, n=19', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=19 WKS, n=19', 'categories': [{'measurements': [{'value': '52.6', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=22 WKS, n=19', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=25 WKS, n=19', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=28 WKS, n=19', 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=31 WKS, n=19', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=34 WKS, n=19', 'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=37 WKS, n=19', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=40 WKS, n=19', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=43 WKS, n=19', 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=52 WKS, n=17', 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=65 WKS, n=17', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=78 WKS, n=16', 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=91 WKS, n=15', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=104 WKS, n=15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Total, MCW >=117 WKS, n=10', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)', 'description': 'Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. The number of participants analyzed varies by category of weeks on study medication because the duration of study medication differs among participants.'}, {'type': 'SECONDARY', 'title': 'Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'classes': [{'title': 'Total, n=19', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '91'}]}]}, {'title': '3 Months (13 Weeks), n=18', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '11'}]}]}, {'title': '6 Months (26 Weeks), n=19', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '24'}]}]}, {'title': '9 Months (39 Weeks), n=19', 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '36'}]}]}, {'title': '12 Months (52 Weeks), n=17', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '36'}]}]}, {'title': '15 Months (65 Weeks), n=17', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '40'}]}]}, {'title': '18 Months (78 Weeks), n=16', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '53'}]}]}, {'title': '21 Months (91 Weeks), n=15', 'categories': [{'measurements': [{'value': '14.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '64'}]}]}, {'title': '24 Months (104 Weeks), n=15', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '76'}]}]}, {'title': '27 Months (117 Weeks), n=10', 'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '91'}]}]}, {'title': '30 Months (130 Weeks), n=4', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)', 'description': 'Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. The number of participants analyzed varies by category of months (weeks) on study medication because the duration of study medication differs among participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'classes': [{'title': 'Baseline, n=19', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}]}]}, {'title': 'Week 1, n=19', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Week 2, n=19', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Week 3, n=19', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Week 4, n=19', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Week 8, n=19', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Week 12, n=16', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Week 16, n=17', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Week 20, n=15', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}]}]}, {'title': 'Week 24, n=17', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Week 28, n=16', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 32, n=16', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Week 36, n=18', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Week 40, n=17', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Week 44, n=17', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Week 48, n=18', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Week 52, n=16', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Week 56, n=14', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Week 60, n=16', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Week 64, n=14', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Week 68, n=14', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Week 72, n=12', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Week 76, n=12', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Week 80, n=12', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 84, n=13', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 88, n=12', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Week 92, n=11', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Week 96, n=11', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Week 100, n=13', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Week 104, n=11', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Week 108, n=11', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Week 112, n=7', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Week 116, n=7', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 120, n=5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Week 124, n=6', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Week 128, n=4', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Week 132, n=2', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}]}]}, {'title': 'Week 136, n=1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Last Visit/Early Withdrawal, n=19', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)', 'description': 'Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. The number of participants analyzed varies by week because some participants prematurely withdrew and the timing of the evaluation differs among participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)', 'description': 'Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. A total of 15 participants who received at least one concomitant ITP medication at Baseline were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'classes': [{'title': 'Any Rescue Therapy', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'New ITP Medication', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Increase in Concomitant ITP Medication from B/L', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Platelet Transfusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Splenectomy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)', 'description': 'Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Normal PC Remained While No Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'This study is an open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for the treatment of participants with idiopathic thrombocytopenic purpura (ITP) who had previously been enrolled in eltrombopag trial TRA108109 (NCT00540423).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Eltrombopag', 'description': "Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '13.57', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian - Japanese Heritage', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-13', 'studyFirstSubmitDate': '2009-01-22', 'resultsFirstSubmitDate': '2011-09-15', 'studyFirstSubmitQcDate': '2009-01-22', 'lastUpdatePostDateStruct': {'date': '2018-09-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-10-31', 'studyFirstPostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Experiencing an Adverse Event (AE) and/or Serious Adverse Event (SAE) Within the Indicated Category', 'timeFrame': 'From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)', 'description': "An AE is any untoward medical occurrence in a participant, temporally associated with the use of a medical product, whether or not related to the product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or its prolongation, results in disability/incapacity, is a congenital anomaly/birth defect, or is another event considered serious. A drug-related AE is any AE that was judged to have a relationship with the study medication by the investigator. The severity of an AE is based on the investigator's clinical judgment."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving a Platelet Count Greater Than or Equal to 50 Giga Unit (10^9) Per Liter (Gi/L) and Less Than or Equal to 400 Gi/L', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)', 'description': 'Platelet counts were measured by blood draw.'}, {'measure': 'Median Platelet Counts', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)', 'description': 'Platelet counts were measured by blood draw.'}, {'measure': 'Percentage of Participants With a Given Maximum Number of Weeks of Continuous Platelet Count Evaluation Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count Categorized by Weeks on Study Medication (Med.)', 'timeFrame': 'From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)', 'description': 'Maximum continuous week (MCW) is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.'}, {'measure': 'Median Number of Maximum Continuous Weeks of Maintaining Platelet Counts Greater Than or Equal to 50 Gi/L and Greater Than or Equal to Twice the Baseline Count at Three-Month Intervals', 'timeFrame': '3, 6, 9, 12, 15, 18, 21, 24, 27, and 30 months (13, 26, 39, 52, 65, 78, 91, 104, 117, and 130 weeks)', 'description': 'Maximum continuous week is measured as the longest period (weeks) for which a participant continuously maintained platelet counts greater than or equal to 50 Gi/L and greater than or equal to twice the Baseline count.'}, {'measure': 'Percentage of Participants Experiencing Any Bleeding Episode After Dosing With Study Medication', 'timeFrame': 'Baseline; Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, 100, 104, 108, 112, 116, 120, 124, 128, 132, and 136; and last visit/early withdrawal visit (up to Day 982)', 'description': 'Any bleeding(s) with an onset on or after the start date of study medication was recorded as a bleeding episode(s).'}, {'measure': 'Percentage of Participants With a Reduction in Use of Baseline Idiopathic Thrombocytopenic Purpura (ITP) Medication', 'timeFrame': 'From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)', 'description': 'Concomitant ITP medications included drugs such as steroids and immunosuppressive drugs. Reduction of concomitant ITP medication was defined as a reduction in dose and/or frequency of administration.'}, {'measure': 'Percentage of Participants Initiating Rescue Medication/Treatment During On-Therapy', 'timeFrame': 'From Baseline (Day 1) to last dose of eltrombopag/early withdrawal visit (up to 981 days)', 'description': 'Rescue therapy included new ITP medication, an increased dose of a concomitant ITP medication from Baseline (B/L), platelet transfusion, and splenectomy.'}]}, 'conditionsModule': {'keywords': ['eltrombopag', 'thrombopoietin receptor agonist', 'ITP', 'blood platelet'], 'conditions': ['Idiopathic Thrombocytopenic Purpura', 'Purpura, Thrombocytopenic, Idiopathic']}, 'referencesModule': {'references': [{'pmid': '23896965', 'type': 'DERIVED', 'citation': 'Katsutani S, Tomiyama Y, Kimura A, Miyakawa Y, Okamoto S, Okoshi Y, Ninomiya H, Kosugi H, Ishii K, Ikeda Y, Hattori T, Katsura K, Kanakura Y. Oral eltrombopag for up to three years is safe and well-tolerated in Japanese patients with previously treated chronic immune thrombocytopenia: an open-label, extension study. Int J Hematol. 2013 Sep;98(3):323-30. doi: 10.1007/s12185-013-1401-1. Epub 2013 Jul 30.'}]}, 'descriptionModule': {'briefSummary': 'An open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for treatment of subjects with ITP who have previously been enrolled in the eltrombopag trial TRA108109 (NCT00540423).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject has signed and dated written informed consent.\n* Subject (\\>=20 years) diagnosed with ITP.\n* Subject previously enrolled in TRA108109 (NCT00540423) must have completed the treatment and follow-up periods as defined in that protocol.\n* Subject has no intercurrent medical event at risk of thrombosis such as thrombophilia.\n* Prolongation of prothrombin time and activated partial thromboplastin time (aPTT) must be within 1.2 times the upper limit of the normal range with no history of hypercoagulable state.\n* A complete blood count (CBC), within the reference range, with the following exceptions:\n* Hemoglobin: patients with haemoglobin level \\< the lower limit of normal are eligible for inclusion if hemorrhage is present.\n* Neutrophil count \\>= 1,500/L (1.5x10E9/L) is required for inclusion.\n* The following clinical chemistries MUST NOT exceed 1.2 times the upper limit of the normal reference range: creatinine, total bilirubin and alkaline phosphatase.\n* The following clinical chemistries MUST NOT exceed 2 times the upper limit of the normal reference range: ALT and AST.\n* Albumin must be not less than 80% of the lower limit of normal.\n* Female subjects must either be:\n* of non-childbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal \\> 1 year), or\n* of childbearing potential and have a negative pregnancy test and agree to use contraceptive methods specified in the GSK List of Highly Effective Methods for Avoidance of Pregnancy from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:\n* Reticulocyte count within the reference range or elevated in case of bleeding.\n\nExclusion Criteria:\n\n* Any severe medical condition (cardiac, hepatic or renal disorder) other than chronic ITP. (Note: "Severe" is defined as \\>= Grade 3 as a rule according to the "Classification of the Severity of Adverse Experiences (PAB/SD Notification No.80, dated 29 June 1992)\n* History of suspected or confirmed arterial or venous thrombosis (e.g., myocardial infarction, deep vein thrombosis) within the last 1 year.\n* History of drug/alcohol abuse or dependence within the last 1 year.\n* Suspected blood disorder other than ITP.\n* Suspected platelet aggregation abnormality.\n* Suspected cyclic thrombocytopenia.\n* Suspected Evans Syndrome.\n* Subjects who met the GSK Liver Stopping Criteria in the previous eltrombopag study TRA108109 (NCT00540423).\n* Current or history of HIV infection or hepatitis B virus or hepatitis C virus infections.\n* Current malignancy or history of malignancy that was treated with chemotherapy or radiotherapy.\n* Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.\n* Subjects who are deemed unsuitable for the study by the investigator (or subinvestigator).\n* Treatment with an investigational drug within 30 days preceding the first dose of study medication.\n* Pre-existing cardiovascular disease, or arrhythmia known to increase the risk of thromboembolic events (e.g. atrial fibrillation).'}, 'identificationModule': {'nctId': 'NCT00828750', 'briefTitle': 'Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)-<Phase III Study>', 'orgStudyIdInfo': {'id': '111433'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Eltrombopag oral tablets once daily', 'interventionNames': ['Drug: Eltrombopag oral tablets']}], 'interventions': [{'name': 'Eltrombopag oral tablets', 'type': 'DRUG', 'otherNames': ['SB-497115-GR oral tablets'], 'description': 'Eltrombopag oral tablets once daily', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '503-8502', 'city': 'Gifu', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.42291, 'lon': 136.76039}}, {'zip': '734-8551', 'city': 'Hiroshima', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '305-8576', 'city': 'Ibaraki', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.81641, 'lon': 135.56828}}, {'zip': '565-0871', 'city': 'Osaka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '596-8501', 'city': 'Osaka', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '160-8582', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}