Ignite Creation Date:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2026-02-25 @ 8:11 PM
Study NCT ID:
NCT02876835
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599718', 'term': 'GSK1278863'}, {'id': 'D000068256', 'term': 'Darbepoetin alfa'}], 'ancestors': [{'id': 'D004921', 'term': 'Erythropoietin'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, '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': 'All-cause mortality, serious adverse events (SAEs) and non-SAEs were collected from Week -4 up to randomization (Day 1) during Run-in placebo period. All-cause mortality, treatment emergent serious adverse events (TESAEs) and non-serious treatment emergent adverse events (non-STEAEs) were collected from randomization (Day 1) up to 4.3 person-years for CV follow-up time period (Treatment Period)', 'description': 'All-cause mortality and Placebo run-in(SAEs/Non-SAEs)used All Randomized(ITT)Population consisting of all randomized participants and analyzed based on treatment to which they were randomized.TESAEs/non-serious TEAEs during treatment period used Safety Population, included all randomized participants who received at least 1 dose of treatment and analyzed based on treatment received.2 participants in All Randomized(ITT)Population did not receive treatment and were excluded from Safety Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Run-in Period: Placebo', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1).', 'otherNumAtRisk': 3872, 'deathsNumAtRisk': 3872, 'otherNumAffected': 0, 'seriousNumAtRisk': 3872, 'deathsNumAffected': 0, 'seriousNumAffected': 63}, {'id': 'EG001', 'title': 'Daprodustat', 'description': 'Participants received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily from randomization (Day 1) up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).', 'otherNumAtRisk': 1937, 'deathsNumAtRisk': 1937, 'otherNumAffected': 851, 'seriousNumAtRisk': 1937, 'deathsNumAffected': 301, 'seriousNumAffected': 850}, {'id': 'EG002', 'title': 'Darbepoetin Alfa', 'description': 'Participants received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) from randomization (Day 1) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).', 'otherNumAtRisk': 1933, 'deathsNumAtRisk': 1935, 'otherNumAffected': 825, 'seriousNumAtRisk': 1933, 'deathsNumAffected': 298, 'seriousNumAffected': 703}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 317, 'numAffected': 247}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 339, 'numAffected': 264}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 239, 'numAffected': 198}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 199, 'numAffected': 162}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 245, 'numAffected': 164}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 199, 'numAffected': 153}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 181, 'numAffected': 149}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 172, 'numAffected': 139}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 163, 'numAffected': 118}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 180, 'numAffected': 133}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 148, 'numAffected': 128}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 141, 'numAffected': 122}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 150, 'numAffected': 127}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 96, 'numAffected': 88}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 128, 'numAffected': 104}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 119, 'numAffected': 88}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 95, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 110, 'numAffected': 105}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 120, 'numAffected': 103}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 101, 'numAffected': 84}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 90, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 81, 'numAffected': 75}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Chronic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 90, 'numAffected': 86}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 52, 'numAffected': 49}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 76, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 53, 'numAffected': 47}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Azotaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 56, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 35, 'numAffected': 35}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 50, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 37, 'numAffected': 36}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 33, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 38, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 34, 'numAffected': 31}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 40, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 43, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 35, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 15, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 16, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 20, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 12, 'numAffected': 9}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 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{'term': 'Vertigo CNS origin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Vitreoretinal traction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Wound secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Bifascicular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Renal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Renal artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3872, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1937, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1933, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.86', 'groupId': 'OG000', 'lowerLimit': '9.80', 'upperLimit': '12.02'}, {'value': '10.63', 'groupId': 'OG001', 'lowerLimit': '9.58', 'upperLimit': '11.77'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.19', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was achieved if the upper limit of the two-sided 95% CI for the hazard ratio was below the pre-specified non-inferiority margin of 1.25.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction \\[MI\\] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied \\[\\*\\] number of participants with at least 1 event) divided by \\[/\\] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (Intent-to-treat \\[ITT\\]) Population comprised of all randomized participants. Participants were analyzed according to the treatment to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Hgb Levels Over the Evaluation Period (Week 28 to Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.74', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.019', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.08', 'ciLowerLimit': '0.03', 'ciUpperLimit': '0.13', '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 greater than -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 Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of covariance (ANCOVA) model with terms for treatment, Baseline Hgb, current ESA use and region.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '10.86', 'groupId': 'OG000', 'lowerLimit': '9.80', 'upperLimit': '12.02'}, {'value': '10.63', 'groupId': 'OG001', 'lowerLimit': '9.58', 'upperLimit': '11.77'}]}]}], 'analyses': [{'pValue': '0.670884', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.19', 'pValueComment': 'The p-value was compared against 0.008333 based on the Holm-Bonferonni adjustment.', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to MACE defined as the time to first occurrence of CEC adjudicated MACE was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariate. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.34', 'groupId': 'OG000', 'lowerLimit': '11.19', 'upperLimit': '13.57'}, {'value': '11.77', 'groupId': 'OG001', 'lowerLimit': '10.65', 'upperLimit': '12.98'}]}]}], 'analyses': [{'pValue': '0.800813', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.22', 'pValueComment': 'The p-value was compared against 0.012500 based on the Holm-Bonferonni adjustment.', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated MACE or thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) was analyzed using a Cox proportional hazards regression model with with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '13.16', 'groupId': 'OG000', 'lowerLimit': '11.97', 'upperLimit': '14.44'}, {'value': '12.22', 'groupId': 'OG001', 'lowerLimit': '11.08', 'upperLimit': '13.46'}]}]}], 'analyses': [{'pValue': '0.886195', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.24', 'pValueComment': 'The p-value was compared against 0.025000 based on the Holm-Bonferonni adjustment.', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated MACE or hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1220', 'groupId': 'OG000'}, {'value': '1265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '17.55', 'groupId': 'OG000', 'lowerLimit': '15.74', 'upperLimit': '19.51'}, {'value': '17.76', 'groupId': 'OG001', 'lowerLimit': '15.97', 'upperLimit': '19.70'}]}]}], 'analyses': [{'pValue': '0.369470', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Subdistribution hazard ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.13', 'estimateComment': "Subdistribution hazard ratio was estimated using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.", 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': "Progression of CKD defined as: 40% decline in estimated glomerular filtration rate (eGFR) from Baseline or end stage renal disease (ESRD) as defined by either initiating chronic dialysis for \\>=90 days or not initiating chronic dialysis when dialysis is indicated or kidney transplantation. Time to first occurrence of CKD progression was analyzed using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) +1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.", 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed. Additionally, this analysis population was restricted to those with a Baseline eGFR \\>=15milliliter per minute (mL/min).'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.35', 'groupId': 'OG000', 'lowerLimit': '7.43', 'upperLimit': '9.35'}, {'value': '8.27', 'groupId': 'OG001', 'lowerLimit': '7.35', 'upperLimit': '9.26'}]}]}], 'analyses': [{'pValue': '0.6197', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.87', 'ciUpperLimit': '1.20', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for vital status follow-up time period', 'description': 'Time to first occurrence of adjudicated all-cause mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the vital status follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.02', 'groupId': 'OG000', 'lowerLimit': '2.48', 'upperLimit': '3.65'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '2.06', 'upperLimit': '3.13'}]}]}], 'analyses': [{'pValue': '0.8976', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.20', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.58', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated CV mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000', 'lowerLimit': '2.40', 'upperLimit': '3.56'}, {'value': '2.76', 'groupId': 'OG001', 'lowerLimit': '2.24', 'upperLimit': '3.36'}]}]}], 'analyses': [{'pValue': '0.6581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.40', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated MI (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.26', 'groupId': 'OG000', 'lowerLimit': '0.92', 'upperLimit': '1.69'}, {'value': '0.95', 'groupId': 'OG001', 'lowerLimit': '0.66', 'upperLimit': '1.33'}]}]}], 'analyses': [{'pValue': '0.8940', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.33', 'ciLowerLimit': '0.85', 'ciUpperLimit': '2.07', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated stroke (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'Occurrences per participant: 0', 'categories': [{'measurements': [{'value': '1493', 'groupId': 'OG000'}, {'value': '1518', 'groupId': 'OG001'}]}]}, {'title': 'Occurrences per participant: 1', 'categories': [{'measurements': [{'value': '318', 'groupId': 'OG000'}, {'value': '317', 'groupId': 'OG001'}]}]}, {'title': 'Occurrences per participant: 2', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Occurrences per participant: 3', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}, {'title': 'Occurrences per participant: 4', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Occurrences per participant: 5', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Occurrences per participant: 6', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Occurrences per participant: 7', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Occurrences per participant: 8', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9422', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.23', 'estimateComment': 'Overall HR is presented using Model 1. Model 1 assumed a common treatment effect, regardless of number of events experienced. HR was estimated using a Prentice, Williams and Peterson(PWP) model, with treatment, dialysis type and region as covariates.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8862', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.24', 'estimateComment': 'First Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. Hazard Ratio (HR) was estimated using a PWP model, with treatment, dialysis type and region as covariates.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6789', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.07', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.39', 'estimateComment': 'Second Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '0.85', 'ciUpperLimit': '2.19', 'estimateComment': 'Third Event Hazard ratio is presented using Model 2. Model 2 assumed treatment effect differs by number of events experienced. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8862', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.24', 'estimateComment': 'First Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8989', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '0.92', 'ciUpperLimit': '1.46', 'estimateComment': 'Subsequent Event Hazard ratio is presented using Model 3. Model 3 assumed treatment effect for first event differs from a common effect for subsequent events. HR was estimated using a PWP model, with treatment, dialysis type and region as covariates.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Number of participants with adjudicated MACE or hospitalization for heart failure (recurrent events analysis) is presented, categorized by number of occurrences of adjudicated MACE or hospitalization for heart failure per participant.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.36', 'groupId': 'OG000', 'lowerLimit': '4.62', 'upperLimit': '6.18'}, {'value': '4.98', 'groupId': 'OG001', 'lowerLimit': '4.27', 'upperLimit': '5.77'}]}]}], 'analyses': [{'pValue': '0.7673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.33', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated CV mortality or non-fatal MI was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '41.13', 'groupId': 'OG000', 'lowerLimit': '38.59', 'upperLimit': '43.80'}, {'value': '38.99', 'groupId': 'OG001', 'lowerLimit': '36.54', 'upperLimit': '41.56'}]}]}], 'analyses': [{'pValue': '0.8601', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.15', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'All-cause hospitalization events were hospital admissions recorded on the hospitalization electronic case report form (eCRF) form with a hospitalization duration \\>=24 hours. Time to first occurrence of all-cause hospitalization was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '7.78', 'groupId': 'OG000', 'lowerLimit': '6.87', 'upperLimit': '8.79'}, {'value': '7.55', 'groupId': 'OG001', 'lowerLimit': '6.65', 'upperLimit': '8.55'}]}]}], 'analyses': [{'pValue': '0.6207', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.03', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.22', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'All-cause hospital re-admissions within 30days are defined as hospital admissions recorded on hospitalization electronic case record form with hospitalization duration of \\>=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was \\>=24hours.Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, current ESA use at randomization and region as covariates.Time to the first occurrence was computed as(event date - randomization date)+1. Incidence rate per 100 person years calculated as(100\\*number of participants with at least 1event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.60', 'groupId': 'OG000', 'lowerLimit': '13.33', 'upperLimit': '15.96'}, {'value': '13.32', 'groupId': 'OG001', 'lowerLimit': '12.11', 'upperLimit': '14.61'}]}]}], 'analyses': [{'pValue': '0.9393', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.26', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated MACE or hospitalization for heart failure or thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.05', 'groupId': 'OG000', 'lowerLimit': '3.41', 'upperLimit': '4.78'}, {'value': '3.30', 'groupId': 'OG001', 'lowerLimit': '2.73', 'upperLimit': '3.96'}]}]}], 'analyses': [{'pValue': '0.9412', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.22', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.56', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.81', 'groupId': 'OG000', 'lowerLimit': '1.39', 'upperLimit': '2.31'}, {'value': '1.43', 'groupId': 'OG001', 'lowerLimit': '1.07', 'upperLimit': '1.89'}]}]}], 'analyses': [{'pValue': '0.8994', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '0.88', 'ciUpperLimit': '1.84', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model with treatment group, current ESA use at randomization, and region as covariates.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.', 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Confirmed 40% Decline in eGFR During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1220', 'groupId': 'OG000'}, {'value': '1265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '8.21', 'groupId': 'OG000', 'lowerLimit': '7.04', 'upperLimit': '9.52'}, {'value': '8.90', 'groupId': 'OG001', 'lowerLimit': '7.69', 'upperLimit': '10.24'}]}]}], 'analyses': [{'pValue': '0.2073', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Subdistribution hazard ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.13', 'estimateComment': "Subdistribution hazard ratio was estimated using Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.", 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': "Time to first occurrence of confirmed 40% decline in eGFR was analyzed using a Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.", 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Chronic Dialysis During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1220', 'groupId': 'OG000'}, {'value': '1265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '12.20', 'groupId': 'OG000', 'lowerLimit': '10.74', 'upperLimit': '13.81'}, {'value': '12.06', 'groupId': 'OG001', 'lowerLimit': '10.63', 'upperLimit': '13.62'}]}]}], 'analyses': [{'pValue': '0.5068', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Subdistribution hazard ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.19', 'estimateComment': "Subdistribution hazard ratio was estimated using Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.", 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': "Time to first occurrence of chronic dialysis was analyzed using a Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Chronic dialysis is defined by either initiating dialysis for \\>=90 days or not initiating chronic dialysis when dialysis is indicated. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.", 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Time to First Occurrence of Kidney Transplant During CV Events Follow-up Time Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1220', 'groupId': 'OG000'}, {'value': '1265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '0.63', 'upperLimit': '1.50'}, {'value': '1.14', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '1.66'}]}]}], 'analyses': [{'pValue': '0.3285', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Subdistribution hazard ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.54', 'estimateComment': "Subdistribution hazard ratio was estimated using Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use, and region as covariates.", 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': "Time to first occurrence of kidney transplant were analyzed using a Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.", 'unitOfMeasure': 'Events per 100 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-randomization Hgb Levels at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1557', 'groupId': 'OG000'}, {'value': '1556', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.76', 'spread': '0.029', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.029', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.03', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.11', '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 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 Hgb measurements. Change from Baseline was defined as post-randomization value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using mixed model repeated measures (MMRM) model fitted from Baseline up to Week 52, excluding values collected during the stabilization period, with factors for treatment, time, current ESA use, region, Baseline Hgb and Baseline Hgb by time and treatment by time interactions.', 'unitOfMeasure': 'Grams per deciliter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1491', 'groupId': 'OG000'}, {'value': '1520', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '1167', 'groupId': 'OG000'}, {'value': '1063', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in response rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.3', 'ciLowerLimit': '5.2', 'ciUpperLimit': '11.4', 'estimateComment': 'Cochran-Mantel-Haenszel (CMH) test adjusted for current ESA use and region was used to compare the number of responders between the treatment groups.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 28 to Week 52', 'description': 'Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}, {'value': '1483', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '63.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.57', 'ciLowerLimit': '2.04', 'ciUpperLimit': '7.11', 'estimateComment': 'Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 28 to Week 52', 'description': "Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / \\[Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)\\].", 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}, {'value': '1483', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '63.2', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Probability', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '0.53', 'ciUpperLimit': '0.57', 'estimateComment': 'Mann-Whitney estimate (Probability) of the treatment effect has been presented.', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 28 to Week 52', 'description': "Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / \\[Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)\\].", 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1469', 'groupId': 'OG000'}, {'value': '1489', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '62.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.94', 'ciLowerLimit': '1.90', 'ciUpperLimit': '5.91', 'estimateComment': 'Hodges-Lehmann estimate of the treatment difference (daprodustat-darbepoetin alfa) and associated two-sided asymptotic 95% CI is presented.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority was to be established if the lower limit of the two-sided 95% confidence interval for the treatment difference was greater than non-inferiority margin of -15%.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 28 to end of study (4.3 person-years for follow-up time period)', 'description': "Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / \\[Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)\\].", 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1469', 'groupId': 'OG000'}, {'value': '1489', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100.0'}, {'value': '62.1', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '100.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Probability', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.52', 'ciUpperLimit': '0.56', 'estimateComment': 'Mann-Whitney estimate (Probability) of the treatment effect has been presented.', 'statisticalMethod': 'van Elteren test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 28 to end of study (4.3 person-years for follow-up time period)', 'description': "Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / \\[Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)\\].", 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'SBP, n=1913, 1884', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1913', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.62', 'spread': '0.488', 'groupId': 'OG000'}, {'value': '-1.17', 'spread': '0.479', 'groupId': 'OG001'}]}]}, {'title': 'DBP, n=1912, 1884', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1912', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.267', 'groupId': 'OG000'}, {'value': '-0.59', 'spread': '0.262', 'groupId': 'OG001'}]}]}, {'title': 'MAP, n=1912, 1884', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1912', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.300', 'groupId': 'OG000'}, {'value': '-0.77', 'spread': '0.294', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7916', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.56', 'ciLowerLimit': '-0.79', 'ciUpperLimit': '1.90', 'estimateComment': 'The difference in change from Baseline in SBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9581', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '-0.09', 'ciUpperLimit': '1.38', 'estimateComment': 'The difference in change from Baseline in DBP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9241', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '1.43', 'estimateComment': 'The difference in change from Baseline in MAP at Week 52 was analyzed with a MMRM approach with an unstructured covariance matrix to compare the difference in LS means between arms.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week -4) and Week 52', 'description': "SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is the average (BP) in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using MMRM model with treatment group + time + current ESA use at randomization + region + Baseline value + Baseline value\\*time + treatment group\\*time, using an unstructured covariance matrix. Data for post-dialysis BP measurements have been presented.", 'unitOfMeasure': 'Millimeter of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in SBP, DBP, MAP at End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1919', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'SBP, n=1919, 1884', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1919', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.19', 'spread': '0.395', 'groupId': 'OG000'}, {'value': '-1.10', 'spread': '0.398', 'groupId': 'OG001'}]}]}, {'title': 'DBP, n=1918, 1884', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1918', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.26', 'spread': '0.229', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.231', 'groupId': 'OG001'}]}]}, {'title': 'MAP, n=1918, 1884', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1918', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.248', 'groupId': 'OG000'}, {'value': '-0.62', 'spread': '0.251', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4420', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '1.02', 'estimateComment': 'For SBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6369', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.11', 'ciLowerLimit': '-0.52', 'ciUpperLimit': '0.75', 'estimateComment': 'For DBP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5490', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.04', 'ciLowerLimit': '-0.65', 'ciUpperLimit': '0.74', 'estimateComment': 'For MAP: Treatment group comparisons were based on an ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week -4) and 51.1 months', 'description': "SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value. Data for post-dialysis BP measurements have been presented.", 'unitOfMeasure': 'Millimeter of mercury', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1919', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '138.50', 'groupId': 'OG000', 'lowerLimit': '128.58', 'upperLimit': '149.18'}, {'value': '157.35', 'groupId': 'OG001', 'lowerLimit': '146.30', 'upperLimit': '169.23'}]}]}], 'analyses': [{'pValue': '0.0074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of exacerbation rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.79', 'ciUpperLimit': '0.98', 'estimateComment': 'Ratio of model estimated exacerbation rates and CIs estimated using negative binomial model with treatment,current ESA use at randomization and region as covariates and logarithm of time on treatment as offset variable for treatment group comparison.', 'statisticalMethod': 'Negative binomial model', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to end of treatment (51.1 months)', 'description': 'BP exacerbation event (based on post-dialysis) was defined as: SBP \\>= 25 millimeter of mercury (mmHg) increased from Baseline or SBP \\>=180 mmHg; 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 with treatment, current ESA use at randomization and region as covariates and the logarithm of time on-treatment as an offset variable. Data for post-dialysis BP measurements have been presented.', 'unitOfMeasure': 'Events per 100 participant years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With at Least One BP Exacerbation Event During Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1919', 'groupId': 'OG000'}, {'value': '1884', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '939', 'groupId': 'OG000'}, {'value': '1012', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 to end of treatment (51.1 months)', 'description': 'BP exacerbation was defined as: SBP \\>= 25 mmHg increased from Baseline or SBP \\>=180 mmHg; DBP \\>=15 mmHg increased from Baseline or DBP \\>=110 mmHg. Number of participants with at least one BP exacerbation event is presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'OG000'}, {'value': '1935', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0113', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.63', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.94', 'estimateComment': 'Hazard ratio was estimated using a Cox proportional hazard regression model adjusted for treatment group, current ESA use and region.', 'statisticalMethod': 'Wald test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to 51.1 months', 'description': 'Percentage of participants permanently stopping randomized 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 On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.42', 'spread': '0.169', 'groupId': 'OG000'}, {'value': '0.78', 'spread': '0.172', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.60', 'spread': '0.171', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.172', 'groupId': 'OG001'}]}]}, {'title': 'Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.197', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.198', 'groupId': 'OG001'}]}]}, {'title': 'Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.32', 'spread': '0.218', 'groupId': 'OG000'}, {'value': '-0.12', 'spread': '0.221', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.36', 'ciLowerLimit': '-0.83', 'ciUpperLimit': '0.11', 'estimateComment': 'Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time,current ESA use at randomization, region,Baseline value and Baseline value by time and treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6761', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.11', 'ciLowerLimit': '-0.59', 'ciUpperLimit': '0.36', 'estimateComment': 'Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3335', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.12', 'ciLowerLimit': '-0.43', 'ciUpperLimit': '0.67', 'estimateComment': 'Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7423', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.81', 'ciUpperLimit': '0.41', 'estimateComment': 'Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher score represents better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.217', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.221', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.223', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.224', 'groupId': 'OG001'}]}]}, {'title': 'Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.35', 'spread': '0.244', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.245', 'groupId': 'OG001'}]}]}, {'title': 'Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.290', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.294', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8268', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.29', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.32', 'estimateComment': 'Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6851', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.47', 'estimateComment': 'Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8316', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.01', 'ciUpperLimit': '0.35', 'estimateComment': 'Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8032', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.35', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '0.46', 'estimateComment': 'Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, Baseline value and Baseline value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'Bodily pain: Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.221', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.225', 'groupId': 'OG001'}]}]}, {'title': 'Bodily pain: Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.223', 'groupId': 'OG000'}, {'value': '0.50', 'spread': '0.224', 'groupId': 'OG001'}]}]}, {'title': 'Bodily pain: Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.261', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.263', 'groupId': 'OG001'}]}]}, {'title': 'Bodily pain: Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.34', 'spread': '0.283', 'groupId': 'OG000'}, {'value': '0.13', 'spread': '0.288', 'groupId': 'OG001'}]}]}, {'title': 'General health: Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.36', 'spread': '0.171', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.174', 'groupId': 'OG001'}]}]}, {'title': 'General health: Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '0.174', 'groupId': 'OG000'}, {'value': '0.48', 'spread': '0.175', 'groupId': 'OG001'}]}]}, {'title': 'General health: Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '0.04', 'spread': '0.201', 'groupId': 'OG001'}]}]}, {'title': 'General health: Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '0.220', 'groupId': 'OG000'}, {'value': '-0.19', 'spread': '0.224', 'groupId': 'OG001'}]}]}, {'title': 'Mental health: Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.204', 'groupId': 'OG000'}, {'value': '0.12', 'spread': '0.208', 'groupId': 'OG001'}]}]}, {'title': 'Mental health: Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.07', 'spread': '0.210', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '0.211', 'groupId': 'OG001'}]}]}, {'title': 'Mental health: Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.67', 'spread': '0.231', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.232', 'groupId': 'OG001'}]}]}, {'title': 'Mental health: Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.85', 'spread': '0.271', 'groupId': 'OG000'}, {'value': '-0.61', 'spread': '0.275', 'groupId': 'OG001'}]}]}, {'title': 'Role-emotional: Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.45', 'spread': '0.253', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '0.258', 'groupId': 'OG001'}]}]}, {'title': 'Role-emotional: Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.17', 'spread': '0.258', 'groupId': 'OG000'}, {'value': '0.43', 'spread': '0.259', 'groupId': 'OG001'}]}]}, {'title': 'Role-emotional: Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.30', 'spread': '0.290', 'groupId': 'OG000'}, {'value': '0.07', 'spread': '0.292', 'groupId': 'OG001'}]}]}, {'title': 'Role-emotional: Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'spread': '0.339', 'groupId': 'OG000'}, {'value': '-0.38', 'spread': '0.344', 'groupId': 'OG001'}]}]}, {'title': 'Role-physical: Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.202', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.205', 'groupId': 'OG001'}]}]}, {'title': 'Role-physical: Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.203', 'groupId': 'OG000'}, {'value': '0.73', 'spread': '0.204', 'groupId': 'OG001'}]}]}, {'title': 'Role-physical: Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.06', 'spread': '0.230', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.232', 'groupId': 'OG001'}]}]}, {'title': 'Role-physical: Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.63', 'spread': '0.259', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '0.263', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning: Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.19', 'spread': '0.224', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '0.228', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning: Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.21', 'spread': '0.224', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.225', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning: Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.04', 'spread': '0.247', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.249', 'groupId': 'OG001'}]}]}, {'title': 'Social functioning: Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.58', 'spread': '0.282', 'groupId': 'OG000'}, {'value': '-0.20', 'spread': '0.286', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8562', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.28', 'estimateComment': 'B pain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6849', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.15', 'ciLowerLimit': '-0.77', 'ciUpperLimit': '0.47', 'estimateComment': 'B pain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9074', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '0.24', 'estimateComment': 'B pain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8765', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '0.32', 'estimateComment': 'B pain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6252', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.40', 'estimateComment': 'GH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7852', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.29', 'estimateComment': 'GH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3614', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.10', 'ciLowerLimit': '-0.46', 'ciUpperLimit': '0.66', 'estimateComment': 'GH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5991', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.08', 'ciLowerLimit': '-0.70', 'ciUpperLimit': '0.54', 'estimateComment': 'GH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8526', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.27', 'estimateComment': 'MH,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4673', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.56', 'ciUpperLimit': '0.61', 'estimateComment': 'MH,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8262', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.31', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.33', 'estimateComment': 'MH,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7380', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.25', 'ciLowerLimit': '-1.00', 'ciUpperLimit': '0.51', 'estimateComment': 'MH,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5997', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.09', 'ciLowerLimit': '-0.80', 'ciUpperLimit': '0.62', 'estimateComment': 'RE,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7649', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.26', 'ciLowerLimit': '-0.98', 'ciUpperLimit': '0.45', 'estimateComment': 'RE,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8175', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.37', 'ciLowerLimit': '-1.18', 'ciUpperLimit': '0.43', 'estimateComment': 'RE,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8591', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.47', 'ciUpperLimit': '0.43', 'estimateComment': 'RE,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9588', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.50', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.06', 'estimateComment': 'RP,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8761', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-0.90', 'ciUpperLimit': '0.23', 'estimateComment': 'RP,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.58', 'ciUpperLimit': '0.70', 'estimateComment': 'RP,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6983', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.19', 'ciLowerLimit': '-0.92', 'ciUpperLimit': '0.53', 'estimateComment': 'RP,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9743', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.62', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.00', 'estimateComment': 'SF,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8405', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '0.31', 'estimateComment': 'SF,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6459', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.13', 'ciLowerLimit': '-0.82', 'ciUpperLimit': '0.56', 'estimateComment': 'SF,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8272', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-1.17', 'ciUpperLimit': '0.41', 'estimateComment': 'SF,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain (b pain), general health (GH), mental health (MH), role-emotional (RE) (role limitations caused by emotional problems), role-physical (RP) (role limitations caused by physical problems), social functioning (SF), physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline (BL) was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.35', 'spread': '0.192', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.195', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.62', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.201', 'groupId': 'OG001'}]}]}, {'title': 'Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.22', 'spread': '0.222', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.223', 'groupId': 'OG001'}]}]}, {'title': 'Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.14', 'spread': '0.250', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '0.253', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.56', 'ciLowerLimit': '-1.09', 'ciUpperLimit': '-0.02', 'estimateComment': 'Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6642', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.12', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.44', 'estimateComment': 'Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.10', 'ciLowerLimit': '-0.72', 'ciUpperLimit': '0.52', 'estimateComment': 'Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.49', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '0.21', 'estimateComment': 'Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'Week 8, n=1238,1187', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1238', 'groupId': 'OG000'}, {'value': '1187', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.200', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '0.203', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=1237,1227', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1237', 'groupId': 'OG000'}, {'value': '1227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.65', 'spread': '0.195', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.196', 'groupId': 'OG001'}]}]}, {'title': 'Week 28, n=968,956', 'denoms': [{'units': 'Participants', 'counts': [{'value': '968', 'groupId': 'OG000'}, {'value': '956', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.224', 'groupId': 'OG000'}, {'value': '-0.10', 'spread': '0.225', 'groupId': 'OG001'}]}]}, {'title': 'Week 52, n=804,780', 'denoms': [{'units': 'Participants', 'counts': [{'value': '804', 'groupId': 'OG000'}, {'value': '780', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.69', 'spread': '0.262', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '0.266', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8703', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.24', 'estimateComment': 'Week 8: Model was fitted from Baseline up to Week 52 and model adjusted Week 8 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3167', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.13', 'ciLowerLimit': '-0.41', 'ciUpperLimit': '0.67', 'estimateComment': 'Week 12: Model was fitted from Baseline up to Week 52 and model adjusted Week 12 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3155', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.47', 'ciUpperLimit': '0.78', 'estimateComment': 'Week 28: Model was fitted from Baseline up to Week 52 and model adjusted Week 28 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8069', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.32', 'ciLowerLimit': '-1.06', 'ciUpperLimit': '0.41', 'estimateComment': 'Week 52: Model was fitted from Baseline up to Week 52 and model adjusted Week 52 data has been presented,with factors for treatment, time,current ESA use at randomization, region, BL value and BL value by time \\& treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in On-treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0253', 'spread': '0.00842', 'groupId': 'OG000'}, {'value': '-0.0018', 'spread': '0.00883', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9724', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0234', 'ciLowerLimit': '-0.0474', 'ciUpperLimit': '0.0005', 'estimateComment': 'MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': 'EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in On-treatment EQ Visual Analogue Scale (EQ-VAS) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '443', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2687', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.7', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '2.9', 'estimateComment': 'MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': "The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'Tired/Low energy/Weak domain: Week 8,n=1340,1294', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1340', 'groupId': 'OG000'}, {'value': '1294', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.72', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '2.94', 'spread': '0.429', 'groupId': 'OG001'}]}]}, {'title': 'Tired/Low energy/Weak domain: Week 12,n=1341,1360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.11', 'spread': '0.437', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '0.434', 'groupId': 'OG001'}]}]}, {'title': 'Tired/Low energy/Weak domain: Week 28,n=1053,1047', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.27', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '1.87', 'spread': '0.496', 'groupId': 'OG001'}]}]}, {'title': 'Tired/Low energy/Weak domain: Week 52,n=870,865', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.20', 'spread': '0.554', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '0.556', 'groupId': 'OG001'}]}]}, {'title': 'Chest pain/SOB domain: Week 8,n=1340,1294', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1340', 'groupId': 'OG000'}, {'value': '1294', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.63', 'spread': '0.358', 'groupId': 'OG000'}, {'value': '1.83', 'spread': '0.363', 'groupId': 'OG001'}]}]}, {'title': 'Chest pain/ SOB domain: Week 12,n=1341,1360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.370', 'groupId': 'OG000'}, {'value': '1.53', 'spread': '0.368', 'groupId': 'OG001'}]}]}, {'title': 'Chest pain/ SOB domain: Week 28,n=1053,1047', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.424', 'groupId': 'OG000'}, {'value': '0.53', 'spread': '0.425', 'groupId': 'OG001'}]}]}, {'title': 'Chest pain/ SOB domain: Week 52,n=870,865', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.71', 'spread': '0.471', 'groupId': 'OG000'}, {'value': '0.47', 'spread': '0.473', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive domain: Week 8,n=1340,1294', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1340', 'groupId': 'OG000'}, {'value': '1294', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.13', 'spread': '0.413', 'groupId': 'OG000'}, {'value': '0.89', 'spread': '0.419', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive domain: Week 12,n=1341,1360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.17', 'spread': '0.414', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '0.412', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive domain: Week 28,n=1053,1047', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.40', 'spread': '0.468', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '0.469', 'groupId': 'OG001'}]}]}, {'title': 'Cognitive domain: Week 52,n=870,865', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.00', 'spread': '0.526', 'groupId': 'OG000'}, {'value': '-0.35', 'spread': '0.527', 'groupId': 'OG001'}]}]}, {'title': 'SOB, no activity: Week 8,n=1340,1294', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1340', 'groupId': 'OG000'}, {'value': '1294', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'SOB, no activity: Week 12,n=1341,1360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.43', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'SOB, no activity: Week 28,n=1053,1047', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '0.50', 'groupId': 'OG001'}]}]}, {'title': 'SOB, no activity: Week 52,n=870,865', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '0.57', 'groupId': 'OG000'}, {'value': '-1.6', 'spread': '0.57', 'groupId': 'OG001'}]}]}, {'title': 'Severity-short breath, Resting: Week 8,n=1340,1294', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1340', 'groupId': 'OG000'}, {'value': '1294', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'Severity-short breath, Resting:Week 12,n=1341,1360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.42', 'groupId': 'OG001'}]}]}, {'title': 'Severity-short breath, Resting:Week 28,n=1053,1047', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.48', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.48', 'groupId': 'OG001'}]}]}, {'title': 'Severity-short breath, Resting:Week 52,n=870,865', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.0', 'spread': '0.53', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Diff std for long time: Week 8,n=1340,1294', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1340', 'groupId': 'OG000'}, {'value': '1294', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.63', 'groupId': 'OG001'}]}]}, {'title': 'Diff std for long time: Week 12,n=1341,1360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.63', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.62', 'groupId': 'OG001'}]}]}, {'title': 'Diff std for long time: Week 28,n=1053,1047', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.71', 'groupId': 'OG001'}]}]}, {'title': 'Diff std for long time: Week 52,n=870,865', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '0.76', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.76', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty sleeping: Week 8,n=1340,1294', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1340', 'groupId': 'OG000'}, {'value': '1294', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.61', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty sleeping: Week 12,n=1341,1360', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1360', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.60', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.59', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty sleeping: Week 28,n=1053,1047', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1053', 'groupId': 'OG000'}, {'value': '1047', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.70', 'groupId': 'OG001'}]}]}, {'title': 'Difficulty sleeping: Week 52,n=870,865', 'denoms': [{'units': 'Participants', 'counts': [{'value': '870', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.78', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9780', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.22', 'ciLowerLimit': '-2.40', 'ciUpperLimit': '-0.03', 'estimateComment': 'Tired/LE/Weak domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9430', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.97', 'ciLowerLimit': '-2.18', 'ciUpperLimit': '0.23', 'estimateComment': 'Tired/LE/Weak domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.60', 'ciLowerLimit': '-1.98', 'ciUpperLimit': '0.77', 'estimateComment': 'Tired/LE/Weak domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9770', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.57', 'ciLowerLimit': '-3.11', 'ciUpperLimit': '-0.03', 'estimateComment': 'Tired/LE/Weak domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9905', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.20', 'ciLowerLimit': '-2.20', 'ciUpperLimit': '-0.20', 'estimateComment': 'CP/SOB,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8939', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.65', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '0.37', 'estimateComment': 'CP/SOB,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'LS mean difference', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8070', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.52', 'ciLowerLimit': '-1.70', 'ciUpperLimit': '0.66', 'estimateComment': 'CP/SOB,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9615', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-2.49', 'ciUpperLimit': '0.13', 'estimateComment': 'CP/SOB,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9015', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.76', 'ciLowerLimit': '-1.91', 'ciUpperLimit': '0.39', 'estimateComment': 'Cog domain,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9781', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.18', 'ciLowerLimit': '-2.32', 'ciUpperLimit': '-0.03', 'estimateComment': 'Cog domain,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8778', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.77', 'ciLowerLimit': '-2.07', 'ciUpperLimit': '0.53', 'estimateComment': 'Cog domain,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9864', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.65', 'ciLowerLimit': '-3.11', 'ciUpperLimit': '-0.19', 'estimateComment': 'Cog domain,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9725', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '0.0', 'estimateComment': 'SOB, no activity,Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7188', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '0.8', 'estimateComment': 'SOB, no activity,Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8903', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '0.5', 'estimateComment': 'SOB, no activity,Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '1.6', 'estimateComment': 'SOB, no activity,Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.2', 'ciUpperLimit': '0.0', 'estimateComment': 'S-SB,Resting, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6908', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.3', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '0.9', 'estimateComment': 'S-SB,Resting, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7462', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.5', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '0.9', 'estimateComment': 'S-SB,Resting, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9770', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.5', 'ciLowerLimit': '-2.9', 'ciUpperLimit': '0.0', 'estimateComment': 'S-SB,Resting, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9471', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '0.3', 'estimateComment': 'Diff std for LT, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8330', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-2.6', 'ciUpperLimit': '0.9', 'estimateComment': 'Diff std for LT, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8918', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.2', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '0.7', 'estimateComment': 'Diff std for LT, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9986', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.2', 'ciLowerLimit': '-5.4', 'ciUpperLimit': '-1.1', 'estimateComment': 'Diff std for LT, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3035', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.4', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '2.1', 'estimateComment': 'Diff sleep, Week8:Model was fitted from Baseline up to Week52 and model adjusted Week8 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9563', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.4', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '0.2', 'estimateComment': 'Diff sleep, Week12:Model was fitted from Baseline up to Week52 and model adjusted Week12 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6548', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '1.5', 'estimateComment': 'Diff sleep, Week28:Model was fitted from Baseline up to Week52 and model adjusted Week28 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9832', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-4.5', 'ciUpperLimit': '-0.2', 'estimateComment': 'Diff sleep, Week52:Model was fitted from Baseline up to Week52 and model adjusted Week52 data has been presented, with factors for treatment, time, current ESA use, region, BL value and BL value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Day 1) and Weeks 8, 12, 28, 52', 'description': 'CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy (LE)/Weak scale consisting of 10 items; 2.Chest Pain (CP)/Shortness of Breath (SOB) scale consisting of 4 items; and 3.Cognitive (Cog) scale consisting of 3 items. The 4 CKD-AQ single items are: shortness of breath, no activity; severity-short breath (S-SB), resting; difficulty standing (diff. std.)for long time (LT) and difficulty sleeping (diff sleep). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1362', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'title': 'Week 8, n=1341,1295', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1295', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.022', 'groupId': 'OG001'}]}]}, {'title': 'Week 12, n=1341,1362', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1341', 'groupId': 'OG000'}, {'value': '1362', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.022', 'groupId': 'OG001'}]}]}, {'title': 'Week 28, n=1054,1051', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1054', 'groupId': 'OG000'}, {'value': '1051', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.025', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.025', 'groupId': 'OG001'}]}]}, {'title': 'Week 52, n=871,865', 'denoms': [{'units': 'Participants', 'counts': [{'value': '871', 'groupId': 'OG000'}, {'value': '865', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.11', 'spread': '0.028', 'groupId': 'OG000'}, {'value': '0.06', 'spread': '0.029', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6917', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.05', 'ciUpperLimit': '0.08', 'estimateComment': 'Week 8: Model was fitted from Baseline up to Week52 and model adjusted Week 8 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9510', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.01', 'ciUpperLimit': '0.11', 'estimateComment': 'Week 12: Model was fitted from Baseline up to Week52 and model adjusted Week 12 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1136', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.04', 'ciLowerLimit': '-0.11', 'ciUpperLimit': '0.03', 'estimateComment': 'Week 28: Model was fitted from Baseline up to Week52 and model adjusted Week 28 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8859', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '0.13', 'estimateComment': 'Week 52: Model was fitted from Baseline up to Week52 and model adjusted Week 52 data has been presented, with factors for treatment, time, current ESA use, region, Baseline value and Baseline value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated more disease severity. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.", 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Post-randomization Estimated Glomerular Filtration Rate (eGFR) at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1869', 'groupId': 'OG000'}, {'value': '1868', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'OG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.88', 'spread': '0.193', 'groupId': 'OG000'}, {'value': '-2.67', 'spread': '0.193', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.7716', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.20', 'ciLowerLimit': '-0.74', 'ciUpperLimit': '0.33', 'estimateComment': 'MMRM model was fitted from Baseline up to Week 52 with factors for treatment, time, current ESA use at randomization, region, Baseline value and Baseline value by time and treatment by time interactions.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': 'Blood samples were collected to analyze estimated glomerular filtration rate. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.', 'unitOfMeasure': 'mL per minute per 1.73 square meter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All Randomized (ITT) Population. Only those participants with data available at the indicated time points were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'FG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}], 'periods': [{'title': 'Run-in Period: Placebo (Week-4 to Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1937'}, {'groupId': 'FG001', 'numSubjects': '1935'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1937'}, {'groupId': 'FG001', 'numSubjects': '1935'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period (51.1 Month)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1937'}, {'groupId': 'FG001', 'numSubjects': '1935'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1873'}, {'groupId': 'FG001', 'numSubjects': '1870'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '65'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Investigator Site Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}]}], 'recruitmentDetails': 'This was a multicenter study conducted across 39 countries. Participants were randomized to receive either daprodustat or darbepoetin alfa.', 'preAssignmentDetails': 'A total of 3872 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1937', 'groupId': 'BG000'}, {'value': '1935', 'groupId': 'BG001'}, {'value': '3872', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Daprodustat', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with daprodustat film-coated tablets at dose levels ranging from 1, 2, 4, 6, 8, 10, 12, 16 and 24 milligrams (mg) orally once daily up to 51.1 month. Study treatment was dose-titrated to achieve and maintain hemoglobin (Hgb) in the target range (10 to 11 grams per deciliter \\[g/dL\\]).'}, {'id': 'BG001', 'title': 'Darbepoetin Alfa', 'description': 'Participants received placebo tablets orally once daily in run-in period from Week-4 up to randomization (Day 1) and subsequently received treatment with darbepoetin alfa as prefilled syringes (PFS) for subcutaneous or intravenous (IV) injection at 4-weekly total dose levels ranging from 20, 30, 40, 60, 80, 100, 150, 200, 300 and 400 microgram (mcg) up to 51.1 month. Darbepoetin alfa IV injection was administered to participants undergoing hemodialysis. Study treatment was dose-titrated to achieve and maintain Hgb in the target range (10 to 11 g/dL).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '14.03', 'groupId': 'BG000'}, {'value': '64.9', 'spread': '13.83', 'groupId': 'BG001'}, {'value': '64.8', 'spread': '13.93', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1102', 'groupId': 'BG000'}, {'value': '1071', 'groupId': 'BG001'}, {'value': '2173', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '835', 'groupId': 'BG000'}, {'value': '864', 'groupId': 'BG001'}, {'value': '1699', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaskan Native', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'Asian - Central/South Asian Heritage', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '129', 'groupId': 'BG002'}]}, {'title': 'Asian - East Asian Heritage', 'measurements': [{'value': '245', 'groupId': 'BG000'}, {'value': '232', 'groupId': 'BG001'}, {'value': '477', 'groupId': 'BG002'}]}, {'title': 'Asian - Japanese Heritage', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Asian - South East Asian Heritage', 'measurements': [{'value': '216', 'groupId': 'BG000'}, {'value': '229', 'groupId': 'BG001'}, {'value': '445', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '183', 'groupId': 'BG000'}, {'value': '185', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'White - Arabic/North African Heritage', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'White - White/Caucasian/European Heritage', 'measurements': [{'value': '1079', 'groupId': 'BG000'}, {'value': '1037', 'groupId': 'BG001'}, {'value': '2116', 'groupId': 'BG002'}]}, {'title': 'Mixed Asian Race', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Mixed Race', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Randomized (Intent-to-treat \\[ITT\\]) Population comprised of all randomized participants. Participants were analyzed according to the treatment to which they were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-30', 'size': 2331832, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-02-08T05:00', 'hasProtocol': True}, {'date': '2021-05-27', 'size': 2384318, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-02-08T05:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3872}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2016-08-19', 'resultsFirstSubmitDate': '2022-02-15', 'studyFirstSubmitQcDate': '2016-08-19', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-12', 'studyFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Occurrence of Adjudicated Major Adverse Cardiovascular Event (MACE) During Cardiovascular (CV) Events Follow-up Time Period (Non-inferiority Analysis)', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to MACE defined as time to first occurrence of Clinical Events Committee (CEC) adjudicated MACE (composite of all-cause mortality, non-fatal myocardial infarction \\[MI\\] and non-fatal stroke) was analyzed using a Cox proportional hazards regression model with treatment group, current erythropoiesis-stimulating agents (ESA) use at randomization and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) plus (+) 1. The incidence rate per 100 person years calculated as (100 multiplied \\[\\*\\] number of participants with at least 1 event) divided by \\[/\\] first event person-years) is presented along with 95 percent (%) confidence interval (CI). First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Mean Change From Baseline in Hgb 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 Hgb measurements. Hgb during the evaluation period was defined as the mean of all available post-randomization Hgb values (on and off-treatment) during the evaluation period (Week 28 to Week 52). For the primary analysis missing post-Baseline Hgb values were imputed using pre-specified multiple imputation methods. Change from Baseline was defined as post-Baseline value minus (-) Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using the Analysis of covariance (ANCOVA) model with terms for treatment, Baseline Hgb, current ESA use and region.'}], 'secondaryOutcomes': [{'measure': 'Time to First Occurrence of Adjudicated MACE During CV Events Follow-up Time Period (Superiority Analysis)', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to MACE defined as the time to first occurrence of CEC adjudicated MACE was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariate. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.'}, {'measure': 'Time to First Occurrence of Adjudicated MACE or Thromboembolic Event During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated MACE or thromboembolic event (vascular access thrombosis, symptomatic deep vein thrombosis or symptomatic pulmonary embolism) was analyzed using a Cox proportional hazards regression model with with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.'}, {'measure': 'Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated MACE or hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period. This endpoint was adjusted for multiplicity using the Holm-Bonferonni method.'}, {'measure': 'Time to First Occurrence of Chronic Kidney Disease (CKD) Progression During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': "Progression of CKD defined as: 40% decline in estimated glomerular filtration rate (eGFR) from Baseline or end stage renal disease (ESRD) as defined by either initiating chronic dialysis for \\>=90 days or not initiating chronic dialysis when dialysis is indicated or kidney transplantation. Time to first occurrence of CKD progression was analyzed using Fine and Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) +1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period."}, {'measure': 'Time to First Occurrence of Adjudicated All-Cause Mortality During Vital Status for Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for vital status follow-up time period', 'description': 'Time to first occurrence of adjudicated all-cause mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the vital status follow-up time period.'}, {'measure': 'Time to First Occurrence of Adjudicated CV Mortality During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated CV mortality was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Time to First Occurrence of Adjudicated Myocardial Infarction (MI) (Fatal and Non-Fatal) During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated MI (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Time to First Occurrence of Adjudicated Stroke (Fatal and Non-Fatal) During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated stroke (fatal and non-fatal) was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Number of Participants With Adjudicated MACE or Hospitalization for Heart Failure (Recurrent Events Analysis)', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Number of participants with adjudicated MACE or hospitalization for heart failure (recurrent events analysis) is presented, categorized by number of occurrences of adjudicated MACE or hospitalization for heart failure per participant.'}, {'measure': 'Time to First Occurrence of Adjudicated CV Mortality or Non-Fatal MI During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated CV mortality or non-fatal MI was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Time to First Occurrence of All-Cause Hospitalization During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'All-cause hospitalization events were hospital admissions recorded on the hospitalization electronic case report form (eCRF) form with a hospitalization duration \\>=24 hours. Time to first occurrence of all-cause hospitalization was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Time to First Occurrence of All-Cause Hospital Re-admission Within 30 Days During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'All-cause hospital re-admissions within 30days are defined as hospital admissions recorded on hospitalization electronic case record form with hospitalization duration of \\>=24 hours and admission date within 30days following previous discharge date of all-cause hospitalization event, where previous hospitalization was \\>=24hours.Time to first occurrence of all-cause hospital re-admission within 30days was analyzed using Cox proportional hazards regression model with treatment group, current ESA use at randomization and region as covariates.Time to the first occurrence was computed as(event date - randomization date)+1. Incidence rate per 100 person years calculated as(100\\*number of participants with at least 1event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event+cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Time to First Occurrence of Adjudicated MACE or Hospitalization for Heart Failure or Thromboembolic Events During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated MACE or hospitalization for heart failure or thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Time to First Occurrence of Adjudicated Hospitalization for Heart Failure During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated hospitalization for heart failure was analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Time to First Occurrence of Adjudicated Thromboembolic Events During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': 'Time to first occurrence of adjudicated thromboembolic events were analyzed using a Cox proportional hazards regression model with treatment group, current ESA use at randomization, and region as covariates. Time to the first occurrence was computed as (event date minus randomization date) + 1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period.'}, {'measure': 'Time to First Occurrence of Confirmed 40% Decline in eGFR During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': "Time to first occurrence of confirmed 40% decline in eGFR was analyzed using a Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period."}, {'measure': 'Time to First Occurrence of Chronic Dialysis During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': "Time to first occurrence of chronic dialysis was analyzed using a Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Chronic dialysis is defined by either initiating dialysis for \\>=90 days or not initiating chronic dialysis when dialysis is indicated. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period."}, {'measure': 'Time to First Occurrence of Kidney Transplant During CV Events Follow-up Time Period', 'timeFrame': 'Up to 4.3 person-years for CV follow-up time period', 'description': "Time to first occurrence of kidney transplant were analyzed using a Fine \\& Gray's proportional subdistribution hazard regression model with treatment group, Baseline ESA use and region as covariates. Time to the first occurrence was computed as (event date minus randomization date)+1. The incidence rate per 100 person years calculated as (100\\*number of participants with at least 1 event)/first event person-years) is presented along with 95% CI. First event person years=(cumulative total time to first event for participants who have the event + cumulative total of censored time for participants without the event)/365.25, based on the CV follow-up time period."}, {'measure': 'Change From Baseline in Post-randomization Hgb Levels at Week 52', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': 'Blood samples were collected from participants for Hgb measurements. Change from Baseline was defined as post-randomization value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using mixed model repeated measures (MMRM) model fitted from Baseline up to Week 52, excluding values collected during the stabilization period, with factors for treatment, time, current ESA use, region, Baseline Hgb and Baseline Hgb by time and treatment by time interactions.'}, {'measure': 'Number of Hgb Responders in the Hgb Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52)', 'timeFrame': 'Week 28 to Week 52', 'description': 'Mean Hgb during the evaluation period was defined as the mean of all evaluable Hgb values during the evaluation period (Week 28 to Week 52) including any evaluable unscheduled Hgb values that were taken during this time period. Hgb responders were defined as participants with a mean Hgb during the evaluation period that falls within the Hgb analysis range of 10-11.5 g/dL.'}, {'measure': 'Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Non-inferiority Analysis', 'timeFrame': 'Week 28 to Week 52', 'description': "Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / \\[Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)\\]."}, {'measure': 'Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Evaluation Period (Week 28 to Week 52): Superiority Analysis', 'timeFrame': 'Week 28 to Week 52', 'description': "Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the evaluation period (Week 28 to Week 52), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during evaluation period is calculated as time in range during the evaluation period / \\[Earlier of (Date of the last evaluable Hgb value, Week 52 visit date) - Later of (Date of the first evaluable Hgb value that between Week 16 and Week 52 inclusive, Week 28 visit date)\\]."}, {'measure': 'Percentage of Time With Hgb in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Non-inferiority Analysis', 'timeFrame': 'Week 28 to end of study (4.3 person-years for follow-up time period)', 'description': "Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / \\[Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)\\]."}, {'measure': 'Percentage of Time With Hemoglobin in the Analysis Range (10 to 11.5 Grams/Deciliter) During Maintenance Period (Week 28 to End of Study): Superiority Analysis', 'timeFrame': 'Week 28 to end of study (4.3 person-years for follow-up time period)', 'description': "Percentage of days for which a participant's Hgb was within the analysis range of 10-11.5 g/dL (both inclusive) during the maintenance period (Week 28 to end of study), including any unscheduled evaluable Hgb values that were taken during this time period was calculated. Percentage of time in the analysis range during maintenance period is calculated as time in range during the maintenance period / \\[Earlier of (Date of the last evaluable Hgb value, End of study date)- Later of (Date of the first evaluable Hgb value that is on or after week 16, Week 28 visit date)\\]."}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Blood Pressure (MAP) at Week 52', 'timeFrame': 'Baseline (Week -4) and Week 52', 'description': "SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is the average (BP) in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using MMRM model with treatment group + time + current ESA use at randomization + region + Baseline value + Baseline value\\*time + treatment group\\*time, using an unstructured covariance matrix. Data for post-dialysis BP measurements have been presented."}, {'measure': 'Change From Baseline in SBP, DBP, MAP at End of Treatment', 'timeFrame': 'Baseline (Week -4) and 51.1 months', 'description': "SBP, DBP and MAP were measured in a seated position after at least a 5-minutes of rest. MAP is an average BP in an individual's arteries during a single cardiac cycle. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date. Analysis was performed using ANCOVA model with terms for treatment group, current ESA use at randomization, region and Baseline value. Data for post-dialysis BP measurements have been presented."}, {'measure': 'Blood Pressure (BP) Exacerbation Event Rate Per 100 Participant Years', 'timeFrame': 'Day 1 to end of treatment (51.1 months)', 'description': 'BP exacerbation event (based on post-dialysis) was defined as: SBP \\>= 25 millimeter of mercury (mmHg) increased from Baseline or SBP \\>=180 mmHg; 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 with treatment, current ESA use at randomization and region as covariates and the logarithm of time on-treatment as an offset variable. Data for post-dialysis BP measurements have been presented.'}, {'measure': 'Number of Participants With at Least One BP Exacerbation Event During Study', 'timeFrame': 'Day 1 to end of treatment (51.1 months)', 'description': 'BP exacerbation was defined as: SBP \\>= 25 mmHg increased from Baseline or SBP \\>=180 mmHg; DBP \\>=15 mmHg increased from Baseline or DBP \\>=110 mmHg. Number of participants with at least one BP exacerbation event is presented.'}, {'measure': 'Percentage of Participants Permanently Stopping Randomized Treatment Due to Meeting Rescue Criteria', 'timeFrame': 'Day 1 to 51.1 months', 'description': 'Percentage of participants permanently stopping randomized treatment due to meeting rescue criteria has been presented.'}, {'measure': 'Change From Baseline in On-treatment Physical Component Score (PCS) Using Short Form (SF)-36 Health-related Quality of Life (HRQoL) Questionnaire at Weeks 8, 12, 28, 52', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). The PCS is an average score derived from 4 domains (physical functioning, role-physical, bodily pain and general health) representing overall physical health. PCS ranges from 0 to 100; higher score represents better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date."}, {'measure': 'Change From Baseline in On-treatment Mental Component Score (MCS) Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). MCS is an average score derived from 4 domains (vitality, social functioning, role-emotional and mental health) representing overall mental health. MCS ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date."}, {'measure': 'Change From Baseline in On-treatment SF-36 HRQoL Scores for Bodily Pain, General Health, Mental Health, Role-Emotional, Role-Physical, Social Functioning at Weeks 8, 12, 28, 52', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: bodily pain (b pain), general health (GH), mental health (MH), role-emotional (RE) (role limitations caused by emotional problems), role-physical (RP) (role limitations caused by physical problems), social functioning (SF), physical functioning and vitality. Each domain is scored from 0 (poorer health) to 100 (better health). Each domain score ranges from 0 to 100, higher score indicates a better health state and better functioning. Change from Baseline (BL) was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date."}, {'measure': 'Change From Baseline in On-treatment Vitality Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Vitality score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date."}, {'measure': 'Change From Baseline in On-treatment Physical Functioning Domain Scores Using SF-36 HRQoL Questionnaire at Weeks 8, 12, 28, 52', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The SF-36 acute version 2 is a 36-item generic quality of life instrument designed to measure a participant's level of performance in the following 8 health domains: physical functioning, role-physical (role limitations caused by physical problems), social functioning, bodily pain, mental health, role-emotional (role limitations caused by emotional problems), vitality and general health. Each domain is scored from 0 (poorer health) to 100 (better health). Physical functioning score ranges from 0 to 100; higher scores represent better health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date."}, {'measure': 'Change From Baseline in On-treatment Health Utility EuroQol 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire Score at Week 52', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': 'EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility, self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale (1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were converted to a single index score by applying country-specific value set formula that attaches weights to dimensions and levels. Range for EQ-5D-5L index score is -0.594 (worst health) to 1 (full health state). Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was latest non-missing pre-dose assessment on or before randomization date.'}, {'measure': 'Change From Baseline in On-treatment EQ Visual Analogue Scale (EQ-VAS) at Week 52', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': "The EQ VAS records the respondent's self-rated health on a vertical VAS, ranging from 0 to 100, where 0 represents the worst imaginable health and 100 represents the best imaginable health. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date."}, {'measure': 'Change From Baseline in On-treatment Chronic Kidney Disease- Anemia Symptoms Questionnaire (CKD-AQ) at Weeks 8, 12, 28, 52', 'timeFrame': 'Baseline (Day 1) and Weeks 8, 12, 28, 52', 'description': 'CKD-AQ is 21-item patient reported outcome measure assessing symptoms and symptom impact in participants with anemia associated with CKD. It had 3 domains: 1.Tired/Low Energy (LE)/Weak scale consisting of 10 items; 2.Chest Pain (CP)/Shortness of Breath (SOB) scale consisting of 4 items; and 3.Cognitive (Cog) scale consisting of 3 items. The 4 CKD-AQ single items are: shortness of breath, no activity; severity-short breath (S-SB), resting; difficulty standing (diff. std.)for long time (LT) and difficulty sleeping (diff sleep). Single-item were recorded based on a 0-100 scoring with 0=worst possible and 100=best possible score. Three domains scores were calculated as average of items in each domain and ranged from 0-100 where 0=worst possible and 100=best possible score. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.'}, {'measure': 'Change From Baseline in On-treatment Patient Global Impression of Severity (PGI-S) at Weeks 8, 12, 28, 52', 'timeFrame': 'Baseline (Pre-dose on Day 1), Weeks 8, 12, 28 and 52', 'description': "The PGI-S is a 1-item questionnaire designed to assess participant's impression of disease severity on a 5-point disease severity scale (0=absent, 1=mild, 2=moderate, 3=severe, or 4=very severe). A higher score indicated more disease severity. Change from Baseline was calculated as on-treatment visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date."}, {'measure': 'Change From Baseline in Post-randomization Estimated Glomerular Filtration Rate (eGFR) at Week 52', 'timeFrame': 'Baseline (Pre-dose on Day 1) and Week 52', 'description': 'Blood samples were collected to analyze estimated glomerular filtration rate. Change from Baseline was calculated as post-Baseline visit value minus Baseline value. Baseline was defined as the latest non-missing pre-dose assessment on or before the randomization date.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GSK1278863', 'hemoglobin', 'anemia', 'non-dialysis', 'erythropoiesis stimulating agents', 'daprodustat', 'chronic kidney disease'], 'conditions': ['Anaemia']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Ajay K. Singh, Kevin Carroll, John J. V. McMurray, Scott Solomon, Vivekanand Jha, Kirsten L. Johansen, Renato D. Lopes, Iain C. Macdougall, Gregorio T. Obrador, Sushrut S. Waikar, Christoph Wanner, David C. Wheeler, Andrzej Wiecek, Allison Blackorby, Borut Cizman, Alexander R. Cobitz, Rich Davies, Tara L. DiMino, Lata Kler, Amy M. Meadowcroft, Lin Taft, Vlado Perkovic for the ASCEND-ND Study Group. DAPRODUSTAT FOR THE TREATMENT OF ANEMIA IN PATIENTS NOT UNDERGOING DIALYSIS. N Engl J Med. 2021; DOI: 10.1056/NEJMoa2113380 PMID: 34739196'}, {'pmid': '34865143', 'type': 'BACKGROUND', 'citation': 'Perkovic V, Blackorby A, Cizman B, Carroll K, Cobitz AR, Davies R, DiMino TL, Jha V, Johansen KL, Lopes RD, Kler L, Macdougall IC, McMurray JJV, Meadowcroft AM, Obrador GT, Solomon S, Taft L, Wanner C, Waikar SS, Wheeler DC, Wiecek A, Singh AK. The ASCEND-ND trial: study design and participant characteristics. Nephrol Dial Transplant. 2022 Oct 19;37(11):2157-2170. doi: 10.1093/ndt/gfab318.'}, {'pmid': '38383961', 'type': 'DERIVED', 'citation': 'Cunningham JW, Claggett BL, Lopes RD, McMurray JJV, Perkovic V, Carroll K, Hiemstra T, Khavandi K, Lukas MA, Ranganathan P, Shannon J, van Adelsberg J, Singh AK, Solomon SD. Daprodustat and Heart Failure in CKD. J Am Soc Nephrol. 2024 May 1;35(5):607-617. doi: 10.1681/ASN.0000000000000321. Epub 2024 Feb 22.'}, {'pmid': '36565721', 'type': 'DERIVED', 'citation': 'Singh AK, McCausland FR, Claggett BL, Wanner C, Wiecek A, Atkins MB, Carroll K, Perkovic V, McMurray JJV, Wittes J, Snapinn S, Blackorby A, Meadowcroft A, Barker T, DiMino T, Mallett S, Cobitz AR, Solomon SD. Analysis of on-treatment cancer safety events with daprodustat versus conventional erythropoiesis-stimulating agents-post hoc analyses of the ASCEND-ND and ASCEND-D trials. Nephrol Dial Transplant. 2023 Jul 31;38(8):1890-1897. doi: 10.1093/ndt/gfac342.'}, {'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': '34739196', 'type': 'DERIVED', 'citation': 'Singh AK, Carroll K, McMurray JJV, Solomon S, Jha V, Johansen KL, Lopes RD, Macdougall IC, Obrador GT, Waikar SS, Wanner C, Wheeler DC, Wiecek A, Blackorby A, Cizman B, Cobitz AR, Davies R, DiMino TL, Kler L, Meadowcroft AM, Taft L, Perkovic V; ASCEND-ND Study Group. Daprodustat for the Treatment of Anemia in Patients Not Undergoing Dialysis. N Engl J Med. 2021 Dec 16;385(25):2313-2324. doi: 10.1056/NEJMoa2113380. Epub 2021 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this multi-center event-driven study in non-dialysis (ND) participants with anemia associated with chronic kidney disease (CKD) is to evaluate the safety and efficacy of daprodustat compared to darbepoetin alfa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age: 18 to 99 years of age (inclusive)\n* CKD stage: Kidney Disease Outcomes Quality Initiative (KDOQI) CKD stages 3, 4, or 5 defined by electronic eGFR using the CKD Epidemiology Collaboration (CKD-EPI) formula.\n* Erythropoietin-stimulating agents (ESAs)/Hgb: Group 1 (not using ESAs): No ESA use within the 6 weeks prior to screening and no ESA use between screening and randomization (Day 1). Group 2 (ESA users): Use of any approved ESA for the 6 weeks prior to screening and continuing between screening and randomization.\n* For Group 1 (not using ESAs), Hgb concentration at Week -8 and Week 1 should be 8 to 10 gram per deciliter (g/dL). For Group 2 (ESA users), Hgb concentration at Week -8 should be 8 to 12 g/dL and at Week 1 should be 8 to 11 g/dL.\n* \\>=80% and \\<=120% compliance with placebo during run-in period.\n* Informed consent (screening only): capable of giving signed informed consent which includes compliance with the requirements and restrictions.\n\nExclusion Criteria:\n\n* Dialysis: On dialysis or clinical evidence of impending need to initiate dialysis within 90 days after study start (Day 1).\n* Kidney transplant: Planned living-related or living-unrelated kidney transplant within 52 weeks after study start (Day 1).\n* Ferritin: \\<=100 nanograms (ng)/milliliter (mL) (\\<=100 micrograms/liter \\[L\\]) at screening.\n* Transferrin saturation (TSAT) (screening only): \\<=20%.\n* Aplasias: History of bone marrow aplasia or pure red cell aplasia.\n* Other causes of anemia: untreated pernicious anemia, thalassemia major, sickle cell disease or myelodysplastic syndrome.\n* Gastrointestinal (GI) bleeding: Evidence of actively bleeding gastric, duodenal, or esophageal ulcer disease or clinically significant GI bleeding \\<=4 weeks prior to screening through to randomization (Day 1).\n* MI or acute coronary syndrome: \\<=4 weeks prior to screening through to randomization (Day 1).\n* Stroke or transient ischemic attack: \\<=4 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: Current uncontrolled hypertension as determined by the investigator.\n* Bazett's corrected QT interval (QTcB) (Day 1): QTcB \\>500 millisecond (msec), or QTcB \\>530 msec in subjects with bundle branch block. There is no Q-T Interval Corrected for Heart Rate (QTc) exclusion for subjects with a predominantly ventricular paced rhythm.\n* Alanine transaminase (ALT): \\>2x upper limit of normal (ULN) at screening.\n* Bilirubin: \\>1.5xULN at screening.\n* Current unstable liver or biliary disease per investigator assessment, generally defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices, persistent jaundice, or cirrhosis.\n* Malignancy: History of malignancy within the 2 years prior to screening through to randomization (Day 1) or currently receiving treatment for cancer, or complex kidney cyst (example \\[e.g.\\] Bosniak Category II F, III or IV) \\> 3 centimeter (cm); with the exception of localized squamous cell or basal cell carcinoma of the skin that has been definitively treated \\>=4 weeks prior to screening.\n* Severe allergic reactions: History of severe allergic or anaphylactic reactions or hypersensitivity to excipients in the investigational product, or darbepoetin alfa.\n* Drugs and supplements: Use of strong inhibitors of Cytochrome P4502C8 (CYP2C8) (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin).\n* Other study participation: Use of other investigational agent or device prior to screening through to randomization (Day 1). At screening, this exclusion applies to use of the investigational agent within 30 days or within five half lives (whichever is longer).\n* Prior treatment with daprodustat: Any prior treatment with daprodustat for treatment duration of \\>30 days.\n* Females only: Subject is pregnant \\[as confirmed by a positive urine human chorionic gonadotrophin (hCG) test for females of reproductive potential (FRP) only\\], subject is breastfeeding, or subject is of reproductive potential and does not agree to follow one of the contraceptive options.\n* Other Conditions: 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 darbepoetin alfa) or prevent understanding of the aims or investigational procedures or possible consequences of the study."}, 'identificationModule': {'nctId': 'NCT02876835', 'briefTitle': 'Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Non-Dialysis (ASCEND-ND)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Phase 3 Randomized, Open-label (Sponsor-blind), Active-controlled, Parallel-group, Multi-center, Event Driven Study in Non-dialysis Subjects With Anemia Associated With Chronic Kidney Disease to Evaluate the Safety and Efficacy of Daprodustat Compared to Darbepoetin Alfa', 'orgStudyIdInfo': {'id': '200808'}, 'secondaryIdInfos': [{'id': '2016-000542-65', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daprodustat', 'description': 'Participants will receive oral daprodustat once daily.', 'interventionNames': ['Drug: Daprodustat', 'Drug: Placebo', 'Drug: Iron Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Darbepoetin alfa', 'description': 'Participants will be administered darbepoetin alfa subcutaneously (SC).', 'interventionNames': ['Drug: Darbepoetin alfa', 'Drug: Placebo', 'Drug: Iron Therapy']}], 'interventions': [{'name': 'Daprodustat', 'type': 'DRUG', 'description': 'The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.', 'armGroupLabels': ['Daprodustat']}, {'name': 'Darbepoetin alfa', 'type': 'DRUG', 'description': 'The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.', 'armGroupLabels': ['Darbepoetin alfa']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).', 'armGroupLabels': ['Daprodustat', 'Darbepoetin alfa']}, {'name': 'Iron Therapy', 'type': 'DRUG', 'description': 'Participants will receive supplemental iron therapy if ferritin is \\<=100 ng/mL or TSAT is \\<=20%. The investigator will choose the route of administration and dose of iron.', 'armGroupLabels': ['Daprodustat', 'Darbepoetin alfa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36420', 'city': 'Andalusia', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.30808, 'lon': -86.48243}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85305', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85027', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '48201', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'zip': '93308', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '90201', 'city': 'Cudahy', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.96057, 'lon': -118.18535}}, {'zip': '92243', 'city': 'El Centro', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.792, 'lon': -115.56305}}, {'zip': '92025', 'city': 'Escondido', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.11921, 'lon': -117.08642}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '91344', 'city': 'Granada Hills', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.26472, 'lon': -118.52314}}, {'zip': '91942', 'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'zip': '90623', 'city': 'La Palma', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.8464, 'lon': -118.04673}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90640', 'city': 'Montebello', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.00946, 'lon': -118.10535}}, {'zip': '91950', 'city': 'National City', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.67811, 'lon': -117.0992}}, {'zip': '92505', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.71571, 'lon': 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States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.52787, 'lon': -73.12761}}, {'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33431', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33134', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33189', 'city': 'Cutler Bay', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.5783, 'lon': -80.3377}}, 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