Viewing Study NCT03400033

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Ignite Creation Date: 2025-12-25 @ 3:00 AM
Ignite Modification Date: 2025-12-26 @ 1:41 AM
Study NCT ID: NCT03400033
Status: COMPLETED
Last Update Posted: 2021-07-12
First Post: 2018-01-08
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599718', 'term': 'GSK1278863'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', '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': 'Treatment emergent serious adverse events (SAEs) and non-serious adverse events (non-serious AEs) were collected up to 52 weeks.', 'description': 'Safety Population was used to assess SAEs and non-serious AEs, which comprised of all randomized participants who have taken at least 1 dose of study treatment. One participant from Randomized (ITT) Population (N=407) did not receive study treatment, hence was not included in Safety Population (N=406).', 'eventGroups': [{'id': 'EG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.', 'otherNumAtRisk': 270, 'deathsNumAtRisk': 270, 'otherNumAffected': 74, 'seriousNumAtRisk': 270, 'deathsNumAffected': 18, 'seriousNumAffected': 80}, {'id': 'EG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.', 'otherNumAtRisk': 136, 'deathsNumAtRisk': 136, 'otherNumAffected': 42, 'seriousNumAtRisk': 136, 'deathsNumAffected': 10, 'seriousNumAffected': 47}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 36, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 21, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 35, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 13, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 26, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arteriovenous fistula site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Acinetobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Campylobacter colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Endocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Enteritis infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'H1N1 influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infected skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Injection site cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Prostatitis Escherichia coli', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Proteus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pseudomembranous colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tubo-ovarian abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arteriovenous fistula thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arteriovenous fistula site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vascular graft occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arteriovenous fistula occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arteriovenous fistula site haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arteriovenous fistula site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arteriovenous graft site stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Multiple fractures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Post procedural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vascular access malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 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'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetic ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Normocytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Catheter site inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Device related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thirst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neuropathic arthropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lip and/or oral cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oropharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Smooth muscle cell neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Calculus urethral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Congenital cystic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombosis in device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Postmenopausal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 136, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.045', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.066', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.05', 'ciLowerLimit': '-0.21', 'ciUpperLimit': '0.10', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was to be established if the lower limit of the two-sided 95 percent (%) confidence interval (CI) for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)', 'description': 'Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region.', 'unitOfMeasure': 'Grams per deciliter (g/dL)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (Intent-to-treat \\[ITT\\]) Population comprised of all randomized participants. Any participant who received a treatment randomization number was considered to have been randomized.'}, {'type': 'SECONDARY', 'title': 'Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.11', 'spread': '11.049', 'groupId': 'OG000'}, {'value': '106.23', 'spread': '15.569', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3354', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.12', 'ciLowerLimit': '-45.66', 'ciUpperLimit': '29.41', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 to Week 52', 'description': 'Average monthly IV iron dose (mg) per participant during Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from Day 1 to Week 52 while the participant was on study treatment and dividing by (the number of days the participant was on study treatment divided by 30.4375 days). Analysis was performed using the ANCOVA model with terms for treatment, Baseline monthly IV iron dose, and region.', 'unitOfMeasure': 'Milligrams', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin Levels at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.069', 'groupId': 'OG000'}, {'value': '0.11', 'spread': '0.098', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.37', 'ciUpperLimit': '0.10', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference is greater than the pre-specified non-inferiority margin of -0.75 g/dL.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': 'Blood samples were collected from participants for hemoglobin measurements. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the post-randomization visit value minus Baseline value. Analysis was performed using a mixed model repeated measures (MMRM) model fitted to hemoglobin data collected after Baseline up to Week 52, excluding values collected during the stabilization period (Day 1 to Week 28). The model included factors for treatment, time, region, Baseline hemoglobin and Baseline hemoglobin by time and treatment by time interaction terms.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '70.83', 'groupId': 'OG000', 'lowerLimit': '50.98', 'upperLimit': '91.07'}, {'value': '61.76', 'groupId': 'OG001', 'lowerLimit': '29.69', 'upperLimit': '85.19'}]}]}], 'analyses': [{'pValue': '0.0034', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.18', 'ciLowerLimit': '2.83', 'ciUpperLimit': '19.56', 'estimateComment': 'Hodges-Lehmann Estimate of Treatment Difference has been reported.', 'statisticalMethod': "Van Elteren's test", 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was to be established if the lower limit of the two-sided 95% CI for the treatment difference was above the non-inferiority margin of - 15%.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 28 to Week 52', 'description': 'Participants received treatment during the study to achieve or maintain hemoglobin level in the target range. Percentage of time for which hemoglobin level was maintained within the analysis range (10 to 11.5 grams/deciliter) has been presented.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with at least one evaluable hemoglobin value during the evaluation period were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1645', 'ciLowerLimit': '0.06', 'ciUpperLimit': '0.27', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 28 to Week 52', 'description': 'Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled hemoglobin values that were taken during this time period. Hemoglobin responders were defined as the number of participants with a mean hemoglobin during the evaluation period that falls within the hemoglobin analysis range of 10-11.5 grams/deciliter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with at least one evaluable hemoglobin value during the evaluation period were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5308', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.26', 'ciUpperLimit': '4.22', 'estimateComment': 'Hazard ratio is estimated using a Cox proportional hazard regression model adjusted for treatment group and region.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 52', 'description': 'Percentage of participants permanently stopping study treatment due to meeting rescue criteria has been presented.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'title': 'SBP', 'categories': [{'measurements': [{'value': '-3.18', 'spread': '1.470', 'groupId': 'OG000'}, {'value': '0.55', 'spread': '2.252', 'groupId': 'OG001'}]}]}, {'title': 'DBP', 'categories': [{'measurements': [{'value': '-2.52', 'spread': '0.764', 'groupId': 'OG000'}, {'value': '-0.29', 'spread': '1.176', 'groupId': 'OG001'}]}]}, {'title': 'MAP', 'categories': [{'measurements': [{'value': '-2.72', 'spread': '0.907', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '1.389', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.73', 'ciLowerLimit': '-9.03', 'ciUpperLimit': '1.56', 'estimateComment': 'SBP', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.23', 'ciLowerLimit': '-4.99', 'ciUpperLimit': '0.54', 'estimateComment': 'DBP', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.60', 'ciLowerLimit': '-5.86', 'ciUpperLimit': '0.67', 'estimateComment': 'MAP', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week -4 ) and Week 52', 'description': "Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model with treatment group, time, region, Baseline value, Baseline value\\*time, treatment group\\*time as variables.", 'unitOfMeasure': 'Millimeter of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SBP, DBP and MAP at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'title': 'SBP', 'categories': [{'measurements': [{'value': '-1.4', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.75', 'groupId': 'OG001'}]}]}, {'title': 'DBP', 'categories': [{'measurements': [{'value': '-1.8', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '0.93', 'groupId': 'OG001'}]}]}, {'title': 'MAP', 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.407', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-4.73', 'ciUpperLimit': '3.72', 'estimateComment': 'SBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.179', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.05', 'ciLowerLimit': '-3.29', 'ciUpperLimit': '1.19', 'estimateComment': 'DBP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.86', 'ciLowerLimit': '-3.50', 'ciUpperLimit': '1.78', 'estimateComment': 'MAP', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week -4) and end of treatment (last on-treatment value until Week 52)', 'description': "Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the last on-treatment visit value minus Baseline value. Analysis was performed using ANCOVA model with terms for treatment group, region and Baseline value. Adjusted mean and standard error have been presented.", 'unitOfMeasure': 'Millimeter of mercury (mmHg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '250.45', 'groupId': 'OG000', 'lowerLimit': '210.69', 'upperLimit': '297.72'}, {'value': '356.91', 'groupId': 'OG001', 'lowerLimit': '280.95', 'upperLimit': '453.41'}]}]}], 'analyses': [{'pValue': '0.0093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of exacerbation rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.94', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 52 weeks', 'description': 'BP exacerbation event is defined (based on post-dialysis BP) as SBP \\>=25 mmHg increased from Baseline or SBP \\>=180 mmHg; or DBP \\>=15 mmHg increased from Baseline or DBP \\>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.', 'unitOfMeasure': 'Events per 100 participant years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One BP Exacerbation Event During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 52 weeks', 'description': 'BP exacerbation (based on post-dialysis BP) is defined as: SBP \\>= 25 mmHg increased from Baseline or SBP \\>=180mmHg; or DBP \\>=15 mmHg increase from Baseline or DBP \\>=110 mmHg. Number of participants with at least 1 BP exacerbation event have been reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline at Weeks 8, 12, 28 and 52 in Patient Global Impression of Severity (PGI-S)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'OG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'classes': [{'title': 'Week 8; n=248, 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.10', 'spread': '0.048', 'groupId': 'OG000'}, {'value': '0.05', 'spread': '0.068', 'groupId': 'OG001'}]}]}, {'title': 'Week 12; n=243, 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.050', 'groupId': 'OG000'}, {'value': '-0.01', 'spread': '0.071', 'groupId': 'OG001'}]}]}, {'title': 'Week 28; n=211, 106', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '0.03', 'spread': '0.077', 'groupId': 'OG001'}]}]}, {'title': 'Week 52; n=170, 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.11', 'spread': '0.063', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.088', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0323', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.32', 'ciUpperLimit': '0.01', 'estimateComment': 'Week 8', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0921', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.06', 'estimateComment': 'Week 12', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1291', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.29', 'ciUpperLimit': '0.08', 'estimateComment': 'Week 28', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0859', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.36', 'ciUpperLimit': '0.06', 'estimateComment': 'Week 52', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Weeks 8, 12, 28, 52', 'description': "The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity of their anemia of Chronic kidney disease (CKD). It is measured on a 5-point disease severity scale ranging from 0 (absent) to 4 (very severe), higher score indicates more disease severity. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline in on-treatment PGI-S scores was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model fitted from Baseline up to Week 52 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Pre-dose Trough Concentration (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat 2 mg', 'description': 'Participants received daprodustat tablets 2 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG001', 'title': 'Daprodustat 4 mg', 'description': 'Participants received daprodustat tablets 4 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG002', 'title': 'Daprodustat 8 mg', 'description': 'Participants received daprodustat tablets 8 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG003', 'title': 'Daprodustat 12 mg', 'description': 'Participants received daprodustat tablets 12 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG004', 'title': 'Daprodustat 16 mg', 'description': 'Participants received daprodustat tablets 16 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG005', 'title': 'Daprodustat 20 mg', 'description': 'Participants received daprodustat tablets 20 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG006', 'title': 'Daprodustat 24 mg', 'description': 'Participants received daprodustat tablets 24 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG007', 'title': 'Daprodustat 32 mg', 'description': 'Participants received daprodustat tablets 32 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG008', 'title': 'Daprodustat 48 mg', 'description': 'Participants received daprodustat tablets 48 mg orally three-times weekly at the time of the pharmacokinetic visit.'}], 'classes': [{'title': 'Daprodustat; n=1, 2, 10, 18, 14, 9, 6, 3, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '6.2400', 'spread': 'NA', 'comment': 'NA indicates that data was not available as geometric coefficient of variation could not be calculated for single participant.', 'groupId': 'OG000'}, {'value': '1.1207', 'spread': '494.71', 'groupId': 'OG001'}, {'value': '0.1786', 'spread': '77.35', 'groupId': 'OG002'}, {'value': '0.3727', 'spread': '277.88', 'groupId': 'OG003'}, {'value': '0.3443', 'spread': '100.78', 'groupId': 'OG004'}, {'value': '0.3871', 'spread': '161.05', 'groupId': 'OG005'}, {'value': '0.1621', 'spread': '42.17', 'groupId': 'OG006'}, {'value': '0.2768', 'spread': '140.82', 'groupId': 'OG007'}, {'value': '0.3486', 'spread': '68.34', 'groupId': 'OG008'}]}]}, {'title': 'GSK2391220; n=4, 17,42, 57, 40, 25, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '25', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.8623', 'spread': '241.17', 'groupId': 'OG000'}, {'value': '0.5893', 'spread': '255.59', 'groupId': 'OG001'}, {'value': '0.6341', 'spread': '123.92', 'groupId': 'OG002'}, {'value': '1.1572', 'spread': '184.51', 'groupId': 'OG003'}, {'value': '1.1654', 'spread': '191.57', 'groupId': 'OG004'}, {'value': '1.1792', 'spread': '168.59', 'groupId': 'OG005'}, {'value': '1.4987', 'spread': '136.35', 'groupId': 'OG006'}, {'value': '1.6974', 'spread': '6.82', 'groupId': 'OG007'}, {'value': '1.3531', 'spread': '19.28', 'groupId': 'OG008'}]}]}, {'title': 'GSK2487818; n=1, 4, 5, 20, 14, 7, 4, 3, 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '7', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.3620', 'spread': 'NA', 'comment': 'NA indicates that data was not available as geometric coefficient of variation could not be calculated for single participant.', 'groupId': 'OG000'}, {'value': '0.2867', 'spread': '111.67', 'groupId': 'OG001'}, {'value': '0.1594', 'spread': '16.91', 'groupId': 'OG002'}, {'value': '0.2996', 'spread': '105.55', 'groupId': 'OG003'}, {'value': '0.3027', 'spread': '69.12', 'groupId': 'OG004'}, {'value': '0.2868', 'spread': '109.23', 'groupId': 'OG005'}, {'value': '0.2585', 'spread': '30.72', 'groupId': 'OG006'}, {'value': '0.2414', 'spread': '29.66', 'groupId': 'OG007'}, {'value': '0.2111', 'spread': '80.56', 'groupId': 'OG008'}]}]}, {'title': 'GSK2506102; n=4, 17, 45, 59, 43, 27, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.9951', 'spread': '122.94', 'groupId': 'OG000'}, {'value': '0.8372', 'spread': '121.27', 'groupId': 'OG001'}, {'value': '0.9634', 'spread': '95.99', 'groupId': 'OG002'}, {'value': '1.5100', 'spread': '105.50', 'groupId': 'OG003'}, {'value': '1.5480', 'spread': '122.95', 'groupId': 'OG004'}, {'value': '1.6555', 'spread': '133.94', 'groupId': 'OG005'}, {'value': '3.2099', 'spread': '67.36', 'groupId': 'OG006'}, {'value': '1.6892', 'spread': '30.44', 'groupId': 'OG007'}, {'value': '1.8595', 'spread': '48.36', 'groupId': 'OG008'}]}]}, {'title': 'GSK2506104; n=6, 17, 45, 59, 43, 27, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.9750', 'spread': '408.49', 'groupId': 'OG000'}, {'value': '1.9588', 'spread': '163.27', 'groupId': 'OG001'}, {'value': '2.0381', 'spread': '124.74', 'groupId': 'OG002'}, {'value': '3.5141', 'spread': '136.72', 'groupId': 'OG003'}, {'value': '3.3872', 'spread': '182.27', 'groupId': 'OG004'}, {'value': '3.6000', 'spread': '173.62', 'groupId': 'OG005'}, {'value': '6.5730', 'spread': '99.82', 'groupId': 'OG006'}, {'value': '4.2068', 'spread': '15.44', 'groupId': 'OG007'}, {'value': '4.1894', 'spread': '23.78', 'groupId': 'OG008'}]}]}, {'title': 'GSK2531398; n=2, 7, 22, 41, 33, 20, 15, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '33', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1.1778', 'spread': '20.55', 'groupId': 'OG000'}, {'value': '0.6069', 'spread': '271.48', 'groupId': 'OG001'}, {'value': '0.2362', 'spread': '76.76', 'groupId': 'OG002'}, {'value': '0.4444', 'spread': '144.99', 'groupId': 'OG003'}, {'value': '0.3917', 'spread': '169.77', 'groupId': 'OG004'}, {'value': '0.3728', 'spread': '197.51', 'groupId': 'OG005'}, {'value': '0.3992', 'spread': '153.15', 'groupId': 'OG006'}, {'value': '0.3963', 'spread': '16.52', 'groupId': 'OG007'}, {'value': '0.2280', 'spread': '56.68', 'groupId': 'OG008'}]}]}, {'title': 'GSK2531401; n=6, 17, 45, 59, 44, 27, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1.4466', 'spread': '190.80', 'groupId': 'OG000'}, {'value': '3.5579', 'spread': '102.68', 'groupId': 'OG001'}, {'value': '4.0910', 'spread': '148.03', 'groupId': 'OG002'}, {'value': '6.8137', 'spread': '102.34', 'groupId': 'OG003'}, {'value': '5.6037', 'spread': '130.97', 'groupId': 'OG004'}, {'value': '8.4611', 'spread': '128.74', 'groupId': 'OG005'}, {'value': '11.7372', 'spread': '65.37', 'groupId': 'OG006'}, {'value': '6.0453', 'spread': '140.63', 'groupId': 'OG007'}, {'value': '16.2584', 'spread': '41.06', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13).', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population comprised of all randomized participants for whom a post-Baseline pharmacokinetic sample was obtained and analyzed. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat 2 mg', 'description': 'Participants received daprodustat tablets 2 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG001', 'title': 'Daprodustat 4 mg', 'description': 'Participants received daprodustat tablets 4 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG002', 'title': 'Daprodustat 8 mg', 'description': 'Participants received daprodustat tablets 8 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG003', 'title': 'Daprodustat 12 mg', 'description': 'Participants received daprodustat tablets 12 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG004', 'title': 'Daprodustat 16 mg', 'description': 'Participants received daprodustat tablets 16 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG005', 'title': 'Daprodustat 20 mg', 'description': 'Participants received daprodustat tablets 20 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG006', 'title': 'Daprodustat 24 mg', 'description': 'Participants received daprodustat tablets 24 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG007', 'title': 'Daprodustat 32 mg', 'description': 'Participants received daprodustat tablets 32 mg orally three-times weekly at the time of the pharmacokinetic visit.'}, {'id': 'OG008', 'title': 'Daprodustat 48 mg', 'description': 'Participants received daprodustat tablets 48 mg orally three-times weekly at the time of the pharmacokinetic visit.'}], 'classes': [{'title': 'Daprodustat; n=8, 20, 49, 57, 45, 28, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '44.5832', 'spread': '227.65', 'groupId': 'OG000'}, {'value': '51.9261', 'spread': '227.59', 'groupId': 'OG001'}, {'value': '113.4049', 'spread': '179.69', 'groupId': 'OG002'}, {'value': '143.8790', 'spread': '233.09', 'groupId': 'OG003'}, {'value': '126.6824', 'spread': '288.50', 'groupId': 'OG004'}, {'value': '212.5087', 'spread': '152.47', 'groupId': 'OG005'}, {'value': '290.3163', 'spread': '87.39', 'groupId': 'OG006'}, {'value': '197.7071', 'spread': '36.53', 'groupId': 'OG007'}, {'value': '310.1938', 'spread': '190.69', 'groupId': 'OG008'}]}]}, {'title': 'GSK2391220; n=8, 19, 50, 59, 45, 28, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2.6298', 'spread': '60.93', 'groupId': 'OG000'}, {'value': '4.0224', 'spread': '134.91', 'groupId': 'OG001'}, {'value': '6.3826', 'spread': '198.78', 'groupId': 'OG002'}, {'value': '8.9535', 'spread': '126.76', 'groupId': 'OG003'}, {'value': '9.5131', 'spread': '167.92', 'groupId': 'OG004'}, {'value': '11.8995', 'spread': '172.35', 'groupId': 'OG005'}, {'value': '22.3378', 'spread': '95.60', 'groupId': 'OG006'}, {'value': '9.3582', 'spread': '71.78', 'groupId': 'OG007'}, {'value': '31.6698', 'spread': '84.08', 'groupId': 'OG008'}]}]}, {'title': 'GSK2487818; n=7, 18, 47, 56, 45, 28, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2.0320', 'spread': '73.45', 'groupId': 'OG000'}, {'value': '3.2703', 'spread': '143.75', 'groupId': 'OG001'}, {'value': '6.3474', 'spread': '175.79', 'groupId': 'OG002'}, {'value': '8.0134', 'spread': '146.43', 'groupId': 'OG003'}, {'value': '6.4276', 'spread': '278.04', 'groupId': 'OG004'}, {'value': '9.6617', 'spread': '207.18', 'groupId': 'OG005'}, {'value': '19.9693', 'spread': '94.09', 'groupId': 'OG006'}, {'value': '8.4327', 'spread': '64.98', 'groupId': 'OG007'}, {'value': '29.3042', 'spread': '72.06', 'groupId': 'OG008'}]}]}, {'title': 'GSK2506102; n=8, 19, 51, 59, 45, 28, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.8328', 'spread': '101.92', 'groupId': 'OG000'}, {'value': '1.4018', 'spread': '84.93', 'groupId': 'OG001'}, {'value': '2.0385', 'spread': '85.59', 'groupId': 'OG002'}, {'value': '2.8357', 'spread': '68.15', 'groupId': 'OG003'}, {'value': '3.2007', 'spread': '89.86', 'groupId': 'OG004'}, {'value': '3.5712', 'spread': '96.48', 'groupId': 'OG005'}, {'value': '6.4555', 'spread': '59.57', 'groupId': 'OG006'}, {'value': '2.4981', 'spread': '71.38', 'groupId': 'OG007'}, {'value': '7.1245', 'spread': '87.62', 'groupId': 'OG008'}]}]}, {'title': 'GSK2506104; n=8, 19, 51, 59, 45, 28, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '3.2020', 'spread': '81.23', 'groupId': 'OG000'}, {'value': '5.2039', 'spread': '98.70', 'groupId': 'OG001'}, {'value': '7.5220', 'spread': '131.81', 'groupId': 'OG002'}, {'value': '10.8186', 'spread': '84.31', 'groupId': 'OG003'}, {'value': '11.5783', 'spread': '130.74', 'groupId': 'OG004'}, {'value': '13.8509', 'spread': '125.27', 'groupId': 'OG005'}, {'value': '24.4926', 'spread': '84.96', 'groupId': 'OG006'}, {'value': '9.5457', 'spread': '73.58', 'groupId': 'OG007'}, {'value': '30.4034', 'spread': '79.13', 'groupId': 'OG008'}]}]}, {'title': 'GSK2531398; n=8, 17, 46, 59, 45, 27, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '27', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '1.2731', 'spread': '57.92', 'groupId': 'OG000'}, {'value': '2.3676', 'spread': '84.23', 'groupId': 'OG001'}, {'value': '3.7348', 'spread': '131.10', 'groupId': 'OG002'}, {'value': '3.8017', 'spread': '177.36', 'groupId': 'OG003'}, {'value': '4.0850', 'spread': '209.29', 'groupId': 'OG004'}, {'value': '6.1029', 'spread': '137.40', 'groupId': 'OG005'}, {'value': '10.7532', 'spread': '98.46', 'groupId': 'OG006'}, {'value': '4.6296', 'spread': '72.00', 'groupId': 'OG007'}, {'value': '14.7844', 'spread': '81.18', 'groupId': 'OG008'}]}]}, {'title': 'GSK2531401; n=7, 19, 51, 59, 45, 28, 16, 3, 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}, {'value': '28', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '2.0473', 'spread': '100.05', 'groupId': 'OG000'}, {'value': '4.0012', 'spread': '88.64', 'groupId': 'OG001'}, {'value': '5.4631', 'spread': '120.63', 'groupId': 'OG002'}, {'value': '8.8488', 'spread': '80.17', 'groupId': 'OG003'}, {'value': '8.4814', 'spread': '93.83', 'groupId': 'OG004'}, {'value': '10.7368', 'spread': '90.83', 'groupId': 'OG005'}, {'value': '14.7926', 'spread': '59.24', 'groupId': 'OG006'}, {'value': '7.1458', 'spread': '174.98', 'groupId': 'OG007'}, {'value': '20.1044', 'spread': '67.56', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13).', 'unitOfMeasure': 'Nanograms per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed (represented as n=X in the category titles).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'FG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '270'}, {'groupId': 'FG001', 'numSubjects': '137'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '269'}, {'groupId': 'FG001', 'numSubjects': '135'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'This was a multicenter study conducted at 90 centers in 13 countries. Participants were randomized to receive either Daprodustat or Epoetin alfa.', 'preAssignmentDetails': 'A total of 595 participants were screened, of which 188 were screen failures. A total of 407 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Daprodustat', 'description': 'Participants received daprodustat tablets with titrated dose levels ranging from 2, 4, 8, 12, 16, 20, 24, 32 and 48 milligrams (mg) orally three-times weekly up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 grams per deciliter \\[g/dL\\]). In order to maintain the study blind, participants also received saline intravenous (IV) injection once weekly or three-times weekly depending on dose level, up to 52 weeks as an inactive treatment for the IV formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'BG001', 'title': 'Epoetin Alfa', 'description': 'Participants received epoetin alfa with titrated dose levels ranging from 1500 Units to 60,000 Units total weekly dose and administered as IV injection once weekly or three-times weekly depending on dose level up to 52 weeks. Study treatment was dose-titrated to achieve and maintain hemoglobin in the target range (10 to 11 g/dL). In order to maintain the study blind, participants also received placebo tablets matching to daprodustat orally three-times weekly up to 52 weeks as an inactive treatment for the tablet formulation. All participants were followed up at 4 to 6 weeks after last dose.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '19-64 Years', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '263', 'groupId': 'BG002'}]}, {'title': '>= 65 Years', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '144', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'BLACK OR AFRICAN AMERICAN', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'AMERICAN INDIAN OR ALASKAN NATIVE', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'ASIAN - CENTRAL/SOUTH ASIAN HERITAGE', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'ASIAN - EAST ASIAN HERITAGE', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'ASIAN - SOUTH EAST ASIAN HERITAGE', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'WHITE - ARABIC/NORTH AFRICAN HERITAGE', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': 'MIXED WHITE RACE', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'MIXED RACE', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'UNKNOWN', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-11-15', 'size': 974519, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-17T03:29', 'hasProtocol': True}, {'date': '2020-09-02', 'size': 1749643, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-17T03:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This is a double-blind study, in which the subject, investigator, site staff and the sponsor will remain blinded to each subjects study treatment assignment throughout the course of the study, with the exception of a limited number of unblinded site staff who are necessary to maintain the blind, as well as a limited number of sponsor staff.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized to receive either daprodustat or epoetin alfa in a parallel manner. .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-18', 'studyFirstSubmitDate': '2018-01-08', 'resultsFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2018-01-08', 'lastUpdatePostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-18', 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Hemoglobin Levels Over the Evaluation Period (Week 28 to Week 52)', 'timeFrame': 'Baseline (Pre-dose on Day 1) and evaluation period (Week 28 to Week 52)', 'description': 'Blood samples were collected from participants for hemoglobin measurements. Hemoglobin during the evaluation period was defined as the mean of all available post-randomization hemoglobin values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis, the missing post-Baseline hemoglobin values were imputed using pre-specified multiple imputations. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the average of post-randomization values during the evaluation period minus Baseline value. Analysis was performed using the Analysis of Covariance (ANCOVA) model with terms for treatment, Baseline hemoglobin, and region.'}], 'secondaryOutcomes': [{'measure': 'Mean Average Monthly On-treatment Intravenous (IV) Iron Dose Per Participant', 'timeFrame': 'Day 1 to Week 52', 'description': 'Average monthly IV iron dose (mg) per participant during Day 1 to Week 52 was determined by calculating the total IV iron dose per participant from Day 1 to Week 52 while the participant was on study treatment and dividing by (the number of days the participant was on study treatment divided by 30.4375 days). Analysis was performed using the ANCOVA model with terms for treatment, Baseline monthly IV iron dose, and region.'}, {'measure': 'Change From Baseline in Hemoglobin Levels at Week 52', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': 'Blood samples were collected from participants for hemoglobin measurements. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the post-randomization visit value minus Baseline value. Analysis was performed using a mixed model repeated measures (MMRM) model fitted to hemoglobin data collected after Baseline up to Week 52, excluding values collected during the stabilization period (Day 1 to Week 28). The model included factors for treatment, time, region, Baseline hemoglobin and Baseline hemoglobin by time and treatment by time interaction terms.'}, {'measure': 'Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)', 'timeFrame': 'Week 28 to Week 52', 'description': 'Participants received treatment during the study to achieve or maintain hemoglobin level in the target range. Percentage of time for which hemoglobin level was maintained within the analysis range (10 to 11.5 grams/deciliter) has been presented.'}, {'measure': 'Number of Hemoglobin Responders in the Hemoglobin Analysis Range (10 to 11.5 Grams/Deciliter) Over Evaluation Period (Week 28 to Week 52)', 'timeFrame': 'Week 28 to Week 52', 'description': 'Mean hemoglobin during the evaluation period was defined as the mean of all evaluable hemoglobin values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled hemoglobin values that were taken during this time period. Hemoglobin responders were defined as the number of participants with a mean hemoglobin during the evaluation period that falls within the hemoglobin analysis range of 10-11.5 grams/deciliter.'}, {'measure': 'Percentage of Participants Permanently Stopping Study Treatment Due to Meeting Rescue Criteria', 'timeFrame': 'Up to Week 52', 'description': 'Percentage of participants permanently stopping study treatment due to meeting rescue criteria has been presented.'}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) at Week 52', 'timeFrame': 'Baseline (Week -4 ) and Week 52', 'description': "Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model with treatment group, time, region, Baseline value, Baseline value\\*time, treatment group\\*time as variables."}, {'measure': 'Change From Baseline in SBP, DBP and MAP at End of Treatment', 'timeFrame': 'Baseline (Week -4) and end of treatment (last on-treatment value until Week 52)', 'description': "Measurements for SBP, DBP and MAP were taken with the participant in a semi-supine or seated position in the dialysis chair after at least a 5-minute rest period. MAP is the average BP in an individual's arteries during a single cardiac cycle. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline was defined as the last on-treatment visit value minus Baseline value. Analysis was performed using ANCOVA model with terms for treatment group, region and Baseline value. Adjusted mean and standard error have been presented."}, {'measure': 'Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years', 'timeFrame': 'Up to 52 weeks', 'description': 'BP exacerbation event is defined (based on post-dialysis BP) as SBP \\>=25 mmHg increased from Baseline or SBP \\>=180 mmHg; or DBP \\>=15 mmHg increased from Baseline or DBP \\>=110 mmHg. The BP exacerbation events per 100 participant years was estimated using the Negative Binomial Model.'}, {'measure': 'Number of Participants With at Least One BP Exacerbation Event During the Study', 'timeFrame': 'Up to 52 weeks', 'description': 'BP exacerbation (based on post-dialysis BP) is defined as: SBP \\>= 25 mmHg increased from Baseline or SBP \\>=180mmHg; or DBP \\>=15 mmHg increase from Baseline or DBP \\>=110 mmHg. Number of participants with at least 1 BP exacerbation event have been reported.'}, {'measure': 'Change From Baseline at Weeks 8, 12, 28 and 52 in Patient Global Impression of Severity (PGI-S)', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Weeks 8, 12, 28, 52', 'description': "The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity of their anemia of Chronic kidney disease (CKD). It is measured on a 5-point disease severity scale ranging from 0 (absent) to 4 (very severe), higher score indicates more disease severity. Baseline value was the latest non-missing pre-dose assessment on or before the randomization date, including those from unscheduled visits. Change from Baseline in on-treatment PGI-S scores was defined as the on-treatment visit value minus Baseline value. Analysis was performed using MMRM model fitted from Baseline up to Week 52 with factors for treatment, time, region, Baseline value and Baseline value by time and treatment by time interactions."}, {'measure': 'Pre-dose Trough Concentration (Ctau) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)', 'timeFrame': 'Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13).'}, {'measure': 'Maximum Observed Concentration (Cmax) of Daprodustat (GSK1278863) and Its Metabolites GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13)', 'timeFrame': 'Pre-dose on Day 1; Pre-dose and at 0.5, 1, 2, 3 hours post-dose on any one post-Baseline visit day between Week 8 and Week 52', 'description': 'Blood samples were collected at indicated time points for pharmacokinetic analysis of daprodustat (GSK1278863) and its metabolites: GSK2391220 (M2), GSK2487818 (M4), GSK2506102 (M5), GSK2506104 (M3), GSK2531398 (M6) and GSK2531401 (M13).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD, EPO, rhEPO, Hemodialysis dependent, Daprodustat'], 'conditions': ['Anaemia']}, 'referencesModule': {'references': [{'pmid': '36005278', 'type': 'DERIVED', 'citation': 'Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8(8):CD013751. doi: 10.1002/14651858.CD013751.pub2.'}, {'pmid': '35918106', 'type': 'DERIVED', 'citation': 'Coyne DW, Singh AK, Lopes RD, Bailey CK, DiMino TL, Huang C, Connaire J, Rastogi A, Kim SG, Orias M, Shah S, Patel V, Cobitz AR, Wanner C. Three Times Weekly Dosing of Daprodustat versus Conventional Epoetin for Treatment of Anemia in Hemodialysis Patients: ASCEND-TD: A Phase 3 Randomized, Double-Blind, Noninferiority Trial. Clin J Am Soc Nephrol. 2022 Sep;17(9):1325-1336. doi: 10.2215/CJN.00550122. Epub 2022 Aug 2.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 3 study in hemodialysis-dependent subjects with anemia will evaluate the efficacy and safety of daprodustat administered three-times weekly compared to epoetin alfa, the current standard of care. This study includes a 4 week Screening Period, a 52 week Treatment Period and a 4 to 6 week follow-up period. Each subject will remain in the study for up to 62 weeks. Approximately 402 subjects will be randomized to receive either daprodustat three times weekly or epoetin alfa three-times weekly or once weekly, depending on dose level.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject must be 18 to 99 years of age inclusive, at the time of signing the informed consent.\n* Use of any approved rhEPO or analog for at least 8 weeks prior to the screening visit and continuing during the screening period until randomization (Day 1).\n* Hgb concentration (measured by HemoCue) within the following range: Week -4: Hgb 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). If Hgb is 11.6 to 11.9 grams/deciliter (7.2 to 7.4 millimoles/liter), up to two retests are allowed; the retest value must be between 8 to 11.5 grams/deciliter (5 to 7.1 millimoles/liter). Day 1: Hgb 8 to 11 grams/deciliter (5 to 6.8 millimoles/liter) and receiving at least the minimum rhEPO or analog dose 3. Hgb\\>11 to 11.5 grams/deciliter (6.8 to 7.1 millimoles/liter) and receiving greater than the minimum rhEPO or analog dose 3.\n* On hemodialysis (including hemofiltration or hemodiafiltration) \\>90 days prior to screening and continuing during the screening period.\n* On hemodialysis (in-center) \\>=3 times per week.\n* Male and female subjects are eligible. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: Not a woman of childbearing potential (WOCBP), or A WOCBP who agrees to follow the contraceptive guidance from at least 28 days prior to first dose of study treatment and for at least 28 days after the last dose of study treatment.\n* Capable of giving signed informed consent.\n* In France, a subject will be eligible for inclusion in this study if he or she is either affiliated to or beneficiary of a social security category.\n\nExclusion Criteria:\n\n* Planned living-related or living-unrelated kidney transplant within 52 weeks after randomization (Day 1).\n* Ferritin: \\<=100 nanograms/milliliter (\\<=100 micrograms/liter), at screening.\n* Transferrin saturation (TSAT): \\<=20 percent, at screening. If TSAT is 18 to 20 percent, then a retest using a new blood sample can be obtained within 7 days of the final laboratory report; the final retest value must be \\>20 percent to confirm eligibility.\n* Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n* Conditions, other than anemia of CKD, which can affect erythropoiesis.\n* Myocardial infarction (MI) or acute coronary syndrome within 8 weeks prior to screening through to randomization (Day 1).\n* Stroke or transient ischemic attack within 8 weeks prior to screening through to randomization (Day 1).\n* Heart failure (HF): Chronic Class IV HF, as defined by the New York Heart Association (NYHA) functional classification system.\n* Current uncontrolled hypertension as determined by the investigator that would contraindicate the use of rhEPO.\n* Bazett's correction of QTc interval (QTcB): at Day 1: QTcB \\>500 milliseconds, or QTcB \\>530 milliseconds in subjects with bundle branch block. There is no QTc (corrected QT) exclusion for subjects with a predominantly ventricular paced rhythm.\n* Liver Disease: presence of any one of the following liver-related laboratory values or conditions, at screening, is exclusionary: ALT \\>2x upper limit of normal (ULN); Bilirubin \\>1.5x ULN; or Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n* Evidence of actively bleeding gastric, duodenal or esophageal ulcer disease OR clinically significant gastro intestinal bleeding \\<= 8 weeks prior to screening through to randomization (Day 1).\n* History of malignancy within 2 years prior to screening through to randomization (Day 1), currently receiving treatment for cancer, or complex kidney cyst (e.g., Bosniak Category IIF, III or IV) \\>3 centimeters.\n* Use of a strong inhibitor of Cytochrome P4502C8 \\[CYP2C8\\] (e.g. gemfibrozil) or a strong inducer of CYP2C8 (e.g. rifampin/rifampicin).\n* History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product (daprodustat) or epoetin alfa.\n* Use of another investigational agent within 30 days or within five half-lives of the investigational agent (whichever is longer) or currently participating in a study of an investigational device prior to screening through to randomization (Day 1).\n* Any prior treatment with daprodustat for treatment duration of \\>30 days.\n* Any other condition, clinical or laboratory abnormality, or examination finding that the investigator considers would put the subject at unacceptable risk, which may affect study compliance (e.g. intolerance to rhEPO) or prevent understanding of the aims or investigational procedures or possible consequences of the study."}, 'identificationModule': {'nctId': 'NCT03400033', 'briefTitle': 'Anemia Studies in Chronic Kidney Disease (CKD): Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor (PHI) Daprodustat-Three-times Weekly Dosing in Dialysis (ASCEND-TD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase 3 Randomized, Double-blind, Active-controlled, Parallel-group, Multi-center Study in Hemodialysis Participants With Anemia of Chronic Kidney Disease to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of Daprodustat Compared to Recombinant Human Erythropoietin, Following a Switch From Recombinant Human Erythropoietin or Its Analogs', 'orgStudyIdInfo': {'id': '204837'}, 'secondaryIdInfos': [{'id': '2017-004372-56', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daprodustat', 'description': 'Subjects randomized to this arm will receive daprodustat tablets titrated doses from 2 to 48 milligrams orally three-times weekly along with saline by IV route for the 52 weeks treatment period.', 'interventionNames': ['Drug: Daprodustat tablets', 'Drug: Saline vials or bags']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Epoetin alfa', 'description': 'Subjects randomized to this arm will receive matching placebo tablets to daprodustat orally three-times weekly and Epoetin alfa by IV route for the 52 weeks treatment period.', 'interventionNames': ['Drug: Matching placebo tablets', 'Drug: Epoetin alfa vials']}], 'interventions': [{'name': 'Daprodustat tablets', 'type': 'DRUG', 'description': 'Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.', 'armGroupLabels': ['Daprodustat']}, {'name': 'Matching placebo tablets', 'type': 'DRUG', 'description': 'Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.', 'armGroupLabels': ['Epoetin alfa']}, {'name': 'Epoetin alfa vials', 'type': 'DRUG', 'description': 'Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.', 'armGroupLabels': ['Epoetin alfa']}, {'name': 'Saline vials or bags', 'type': 'DRUG', 'description': '0.9% sodium chloride saline vials or bags administered by the IV route.', 'armGroupLabels': ['Daprodustat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85210', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 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