Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 9:09 PM
Study NCT ID:
NCT01896232
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2013-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006962', 'term': 'Hyperparathyroidism, Secondary'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D006961', 'term': 'Hyperparathyroidism'}, {'id': 'D010279', 'term': 'Parathyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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': 'C583569', 'term': 'etelcalcetide hydrochloride'}, {'id': 'D000069449', 'term': 'Cinacalcet'}], 'ancestors': [{'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '866-572-6436', 'title': 'Study Director', 'organization': 'Amgen Inc.'}, 'certainAgreement': {'otherDetails': "The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Day 1 until 30 days after the last dose; the treatment period was 26 weeks.', 'description': 'Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.', 'eventGroups': [{'id': 'EG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.', 'otherNumAtRisk': 341, 'otherNumAffected': 259, 'seriousNumAtRisk': 341, 'seriousNumAffected': 93}, {'id': 'EG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.', 'otherNumAtRisk': 338, 'otherNumAffected': 278, 'seriousNumAtRisk': 338, 'seriousNumAffected': 85}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 62}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 44}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Blood calcium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 203}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 232}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 17}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 22}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 21}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 21}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Antiphospholipid syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Mitral valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebrovascular arteriovenous malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Duodenitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastrointestinal necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haemorrhoidal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oesophagitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Retroperitoneal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bile duct stone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arteriovenous graft site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 3}, {'groupId': 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disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Amputation stump pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hemiparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Myasthenia gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Neurological symptom', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral sensorimotor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Sopor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hydrothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pleurisy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Skin ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Brachiocephalic vein stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Superior vena cava syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Venous stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 341, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 338, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'OG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000'}, {'value': '77.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Stratified Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.48', 'ciLowerLimit': '-17.45', 'ciUpperLimit': '-3.51', 'groupDescription': 'The analysis was conducted on the Full Analysis Set (683 participants). Imputation under the non-inferiority null method was applied to participants who did not have PTH data during the EAP.\n\nThe Mantel-Haenszel estimator was used to calculate the treatment difference between the proportions (Cinacalcet - Etelcalcetide) stratified by screening PTH level and region.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Etelcalcetide was considered non-inferior to cinacalcet if the upper bound of the 2-sided 95% confidence interval (CI) of the treatment difference (cinacalcet - etelcalcetide) was \\< 12%, the prespecified margin for non-inferiority.'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set participants with PTH data during the EAP'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'OG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.2', 'groupId': 'OG000'}, {'value': '52.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.65', 'ciLowerLimit': '1.21', 'ciUpperLimit': '2.23', 'estimateComment': 'The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.', 'groupDescription': 'Achievement of \\> 50% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel (CMH) test stratified by screening PTH level and region.\n\nSuperiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'OG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.59', 'ciLowerLimit': '1.16', 'ciUpperLimit': '2.17', 'estimateComment': 'The CMH stratified odds ratio is Etelcalcetide : Cinacalcet.', 'groupDescription': 'Achievement of \\> 30% reduction in mean predialysis serum PTH from baseline during the EAP was analyzed using the Cochran-Mantel-Haenszel test stratified by screening PTH level and region.\n\nSuperiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and the efficacy assessment phase (Week 20 to Week 27)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants were considered non-responders if they did not have PTH data during the EAP (ie, non-responder imputation).'}, {'type': 'SECONDARY', 'title': 'Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'OG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.89', 'ciUpperLimit': '1.49', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.15', 'estimateComment': 'The treatment rate ratio is Etelcalcetide : Cinacalcet.', 'groupDescription': 'Analyzed using a generalized linear mixed model with Poisson regression, including screening value of the number of days of nausea and vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.\n\nSuperiority of etelcalcetide compared with cinacalcet was tested at the 5% significance level (2-sided).', 'statisticalMethod': 'Generalized Linear Mixed Model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'First 8 weeks', 'description': 'Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was \\> 0 or where the episodes of vomiting score was \\> 0.', 'unitOfMeasure': 'days of vomiting or nausea per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '310', 'groupId': 'OG000'}, {'value': '298', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'OG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.28', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-9.83', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.48', 'ciLowerLimit': '-4.76', 'ciUpperLimit': '-2.21', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.65', 'estimateComment': 'Treatment difference is Etelcalcetide - Cinacalcet.', 'groupDescription': 'Analyzed using a repeated measures mixed effects model, including treatment group, randomization stratification factors (screening PTH level and region), study week, and study week by treatment as fixed effects.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and the efficacy assessment phase (weeks 20 - 27)', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '340', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'OG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.59', 'estimateComment': 'The CMH-stratified odds ratio is Etelcalcetide : Cinacalcet.', 'groupDescription': 'Analyzed using the Cochran-Mantel-Haenszel method stratified by screening PTH level and region.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Efficacy assessment phase (weeks 20 - 27)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set; participants with no phosphorus assessments during the EAP were considered non-responders.'}, {'type': 'SECONDARY', 'title': 'Mean Severity of Nausea in the First 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '339', 'groupId': 'OG000'}, {'value': '339', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'OG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.48', 'spread': '0.06', 'groupId': 'OG000'}, {'value': '0.45', 'spread': '0.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.03', 'ciLowerLimit': '-0.18', 'ciUpperLimit': '0.12', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.08', 'estimateComment': 'Treatment difference is Etelcalcetide - Cinacalcet.', 'groupDescription': 'Analyzed using an analysis of covariance (ANCOVA) model adjusted for screening PTH level and region.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'First 8 weeks', 'description': 'Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data'}, {'type': 'SECONDARY', 'title': 'Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '324', 'groupId': 'OG000'}, {'value': '331', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'OG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.02', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.02', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment Rate Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.72', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.22', 'estimateComment': 'The treatment rate ratio is Etelcalcetide : Cinacalcet.', 'groupDescription': 'This analysis was conducted using a generalized linear mixed model with Poisson regression including screening value of the number of episodes of vomiting, treatment, stratification factors (screening PTH level and region), study weeks, and treatment by study weeks as covariates.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'First 8 weeks', 'description': 'The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.\n\nFor participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.', 'unitOfMeasure': 'vomiting episodes per week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set with available data. For participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'FG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '343'}, {'groupId': 'FG001', 'numSubjects': '340'}]}, {'type': 'Received Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '341'}, {'groupId': 'FG001', 'numSubjects': '338'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '294'}, {'groupId': 'FG001', 'numSubjects': '287'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '53'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'This study was conducted at 164 centers in Austria, Belgium, Canada, the Czech Republic, Denmark, Estonia, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, New Zealand, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, and the United States. Participants were enrolled from 13 August 2013 to 16 May 2014.', 'preAssignmentDetails': 'Eligible participants were stratified by screening serum parathyroid hormone (PTH) level (\\< 900 or ≥ 900 pg/mL) and region (North America or non-North America) and were randomized 1:1 to receive etelcalcetide intravenously (IV) plus oral placebo or oral cinacalcet plus placebo IV.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'BG000'}, {'value': '340', 'groupId': 'BG001'}, {'value': '683', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.'}, {'id': 'BG001', 'title': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.3', 'spread': '14.4', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '13.8', 'groupId': 'BG001'}, {'value': '54.7', 'spread': '14.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '243', 'groupId': 'BG000'}, {'value': '262', 'groupId': 'BG001'}, {'value': '505', 'groupId': 'BG002'}]}]}, {'title': '≥ 65 years', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '178', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '151', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '299', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '192', 'groupId': 'BG001'}, {'value': '384', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '277', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '538', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Ethnicity', 'classes': [{'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic/Latino', 'categories': [{'measurements': [{'value': '302', 'groupId': 'BG000'}, {'value': '302', 'groupId': 'BG001'}, {'value': '604', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stratification Factor: Screening Serum Parathyroid Hormone (PTH)', 'classes': [{'title': '< 900 pg/mL', 'categories': [{'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '340', 'groupId': 'BG002'}]}]}, {'title': '≥ 900 pg/mL', 'categories': [{'measurements': [{'value': '172', 'groupId': 'BG000'}, {'value': '171', 'groupId': 'BG001'}, {'value': '343', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Stratification Factor: Region', 'classes': [{'title': 'North America', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}]}]}, {'title': 'Non-North America', 'categories': [{'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '475', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Parathyroid Hormone', 'classes': [{'categories': [{'measurements': [{'value': '1138.71', 'spread': '706.77', 'groupId': 'BG000'}, {'value': '1092.12', 'spread': '622.81', 'groupId': 'BG001'}, {'value': '1115.52', 'spread': '666.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Corrected Calcium', 'classes': [{'categories': [{'measurements': [{'value': '9.58', 'spread': '0.67', 'groupId': 'BG000'}, {'value': '9.67', 'spread': '0.71', 'groupId': 'BG001'}, {'value': '9.62', 'spread': '0.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Phosphorus', 'classes': [{'categories': [{'measurements': [{'value': '5.82', 'spread': '1.58', 'groupId': 'BG000'}, {'value': '5.81', 'spread': '1.69', 'groupId': 'BG001'}, {'value': '5.81', 'spread': '1.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Data available for 341 and 337 participants in each treatment group respectively.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Corrected Calcium Phosphorus Product (cCa x P)', 'classes': [{'categories': [{'measurements': [{'value': '55.65', 'spread': '15.37', 'groupId': 'BG000'}, {'value': '56.36', 'spread': '17.15', 'groupId': 'BG001'}, {'value': '56.00', 'spread': '16.27', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Data available for 341 and 337 participants in each treatment group respectively.', 'unitOfMeasure': 'mg²/dL²', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full Analysis Set (FAS), defined as all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 683}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'dispFirstSubmitDate': '2015-10-07', 'completionDateStruct': {'date': '2015-01-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-08', 'studyFirstSubmitDate': '2013-07-08', 'dispFirstSubmitQcDate': '2015-10-07', 'resultsFirstSubmitDate': '2017-02-07', 'studyFirstSubmitQcDate': '2013-07-08', 'dispFirstPostDateStruct': {'date': '2015-10-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-07', 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With > 30% Reduction From Baseline in Mean Parathyroid Hormone During the Efficacy Assessment Phase - Non-inferiority Analysis', 'timeFrame': 'Baseline and the efficacy assessment phase (EAP; defined as Weeks 20 to 27, inclusive).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With > 50% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase', 'timeFrame': 'Baseline and the efficacy assessment phase (Weeks 20 to 27, inclusive).'}, {'measure': 'Percentage of Participants With > 30% Reduction From Baseline in Mean PTH During the Efficacy Assessment Phase', 'timeFrame': 'Baseline and the efficacy assessment phase (Week 20 to Week 27)'}, {'measure': 'Mean Number of Days of Vomiting or Nausea Per Week in the First 8 Weeks', 'timeFrame': 'First 8 weeks', 'description': 'Participants completed the Nausea/Vomiting Symptom Assessment (NVSA) questionnaire daily. This questionnaire asked participants to indicate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined) and if they had vomited in the past 24 hours. A day of vomiting or nausea was defined as those where the severity of nausea score was \\> 0 or where the episodes of vomiting score was \\> 0.'}, {'measure': 'Percent Change From Baseline in Mean Corrected Calcium During the Efficacy Assessment Phase', 'timeFrame': 'Baseline and the efficacy assessment phase (weeks 20 - 27)'}, {'measure': 'Percentage of Participants With Mean Predialysis Serum Phosphorus ≤ 4.5 mg/dL During the Efficacy Assessment Phase', 'timeFrame': 'Efficacy assessment phase (weeks 20 - 27)'}, {'measure': 'Mean Severity of Nausea in the First 8 Weeks', 'timeFrame': 'First 8 weeks', 'description': 'Severity of nausea was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asked participants to rate the severity of nausea on a scale from 0 (no nausea) to 10 (as severe as can be imagined). For each participant, the mean severity of nausea was calculated by averaging all available daily severities (including zeroes) reported in the first 8 weeks.'}, {'measure': 'Mean Number of Episodes of Vomiting Per Week in the First 8 Weeks', 'timeFrame': 'First 8 weeks', 'description': 'The number of vomiting episodes was assessed using the Nausea and Vomiting Symptom Assessment questionnaire which asks participants on a daily basis how many times they vomited in the past 24 hours. The number of episodes in a week is the sum of all reported daily episodes in the week.\n\nFor participants providing less than 7 days of responses to NVSA questions in any given week, data from that week did not contribute to the analysis.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Secondary Hyperparathyroidism, renal, kidney, kidneys, dialysis, hemodialysis, chronic kidney disease, CKD, SHPT'], 'conditions': ['Secondary Hyperparathyroidism', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '28097356', 'type': 'BACKGROUND', 'citation': 'Block GA, Bushinsky DA, Cheng S, Cunningham J, Dehmel B, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Moe SM, Patel UD, Silver J, Sun Y, Wang H, Chertow GM. Effect of Etelcalcetide vs Cinacalcet on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: A Randomized Clinical Trial. JAMA. 2017 Jan 10;317(2):156-164. doi: 10.1001/jama.2016.19468.'}, {'pmid': '29392552', 'type': 'BACKGROUND', 'citation': 'Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.'}, {'pmid': '28803497', 'type': 'BACKGROUND', 'citation': 'Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.'}, {'pmid': '29534286', 'type': 'BACKGROUND', 'citation': 'Wu B, Melhem M, Subramanian R, Chen P, Jaramilla Sloey B, Fouqueray B, Hock MB, Skiles GL, Chow AT, Lee E. Clinical Pharmacokinetics and Pharmacodynamics of Etelcalcetide, a Novel Calcimimetic for Treatment of Secondary Hyperparathyroidism in Patients With Chronic Kidney Disease on Hemodialysis. J Clin Pharmacol. 2018 Jun;58(6):717-726. doi: 10.1002/jcph.1090. Epub 2018 Mar 13.'}, {'pmid': '30875390', 'type': 'BACKGROUND', 'citation': 'Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.'}, {'pmid': '32082556', 'type': 'BACKGROUND', 'citation': 'Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.'}], 'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that treatment with etelcalcetide (AMG 416) is not inferior to treatment with cinacalcet for lowering serum parathyroid hormone (PTH) levels by \\> 30% from baseline among patients with chronic kidney disease (CKD) and secondary hyperparathyroidism (SHPT) who require management with hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible subjects must be receiving adequate thrice weekly maintenance hemodialysis with a dialysate calcium concentration ≥ 2.5 mEq/L for at least 3 months prior to screening laboratory assessments\n* Subjects must have SHPT as defined by one central laboratory screening predialysis serum PTH value \\> 500 pg/mL, measured on separate days within 2 weeks prior to randomization\n* Subjects must have one serum cCa value ≥ 8.3 mg/dL obtained before dialysis within 2 weeks of the date of randomization\n* Subjects receiving calcium supplements must have no more than a maximum dose change of 50% within 2 weeks before screening laboratory assessments are obtained, and the dose must remain unchanged through randomization\n\nExclusion Criteria:\n\n* Eligible subjects cannot have received cinacalcet during the 3 months preceding the first screening laboratory assessment\n* Other criteria may apply'}, 'identificationModule': {'nctId': 'NCT01896232', 'briefTitle': 'Head-to-Head Study of Etelcalcetide (AMG 416) and Cinacalcet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Multicenter, Multiple-dose, Two-arm, Active-controlled, Double-blind, Double-dummy Study to Compare the Therapeutic Efficacy and Safety of Oral Doses of Cinacalcet HCl With Intravenous Doses of AMG 416 in Hemodialysis Subjects With Secondary Hyperparathyroidism', 'orgStudyIdInfo': {'id': '20120360'}, 'secondaryIdInfos': [{'id': '2013-000192-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cinacalcet', 'description': 'Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.', 'interventionNames': ['Drug: Cinacalcet', 'Drug: Intravenous Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Etelcalcetide', 'description': 'Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.', 'interventionNames': ['Drug: Etelcalcetide', 'Drug: Oral Placebo']}], 'interventions': [{'name': 'Etelcalcetide', 'type': 'DRUG', 'otherNames': ['AMG 416'], 'description': 'Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.', 'armGroupLabels': ['Etelcalcetide']}, {'name': 'Cinacalcet', 'type': 'DRUG', 'otherNames': ['Sensipar®, Mimpara®'], 'description': 'Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.', 'armGroupLabels': ['Cinacalcet']}, {'name': 'Oral Placebo', 'type': 'DRUG', 'description': 'Administered orally once a day.', 'armGroupLabels': ['Etelcalcetide']}, {'name': 'Intravenous Placebo', 'type': 'DRUG', 'description': 'Administered intravenously (IV) three times per week.', 'armGroupLabels': ['Cinacalcet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Azusa', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.13362, 'lon': -117.90756}}, {'zip': '93306', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '91910', 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