Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT03636269
Status:
COMPLETED
Last Update Posted:
2022-04-26
First Post:
2018-08-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000657129', 'term': 'difelikefalin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials.gov@caratherapeutics.com', 'phone': '203-406-3700', 'title': 'Frédérique Menzaghi, PhD', 'organization': 'Cara Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week', 'otherNumAtRisk': 235, 'deathsNumAtRisk': 235, 'otherNumAffected': 56, 'seriousNumAtRisk': 235, 'deathsNumAffected': 2, 'seriousNumAffected': 58}, {'id': 'EG001', 'title': 'Double-blind Placebo', 'description': 'IV Placebo administered after each dialysis session (3 times/week)\n\nPlacebo: IV placebo administered three times/week', 'otherNumAtRisk': 236, 'deathsNumAtRisk': 236, 'otherNumAffected': 43, 'seriousNumAtRisk': 236, 'deathsNumAffected': 2, 'seriousNumAffected': 51}, {'id': 'EG002', 'title': 'Open-label CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week', 'otherNumAtRisk': 399, 'deathsNumAtRisk': 399, 'otherNumAffected': 204, 'seriousNumAtRisk': 399, 'deathsNumAffected': 15, 'seriousNumAffected': 130}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 45}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 52}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 31}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 25}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 24}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 20}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 20}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Atrioventricular block second degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Aortic valve stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Myocardial ishaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Impaired gastric emptying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Alcoholic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diabetic gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Subdural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Thermal burn', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vascular access complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 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fistula site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Abdominal wall wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Fractured ischium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Haemodialysis complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hand fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Bleeding time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 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'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Calciphylaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diabetes mellitus inadequate control', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 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'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Gastric neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 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399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertensive encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, 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'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Delayed ischaemic neurological deficit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Lumbar radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Posterior reversible encephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Vertebrobasilar insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Diabetic foot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Abdominal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Catheter placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Multiple drug therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Hypertensive emergency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Temporal arteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}, {'term': 'Pneumonia escherichia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 236, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 399, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'IV Placebo administered after each dialysis session (3 times/week)\n\nPlacebo: IV placebo administered three times/week'}], 'classes': [{'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '63.9'}, {'value': '42.2', 'groupId': 'OG001', 'lowerLimit': '32.5', 'upperLimit': '52.5'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '1.08', 'ciUpperLimit': '2.41', 'statisticalMethod': 'Cui, Hung, Wang', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". LS means estimated percent, odds ratio and P value used a logistic regression model.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥4 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'IV Placebo administered after each dialysis session (3 times/week)\n\nPlacebo: IV placebo administered three times/week'}], 'classes': [{'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '33.0', 'upperLimit': '50.0'}, {'value': '28.4', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '36.7'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.77', 'ciLowerLimit': '1.14', 'ciUpperLimit': '2.74', 'statisticalMethod': 'Cui, Hung, Wang', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 12', 'description': 'Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". LS means estimated percent, odds ratio and P value used a logistic regression model.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'IV Placebo administered after each dialysis session (3 times/week)\n\nPlacebo: IV placebo administered three times/week'}], 'classes': [{'categories': [{'measurements': [{'value': '-16.6', 'groupId': 'OG000', 'lowerLimit': '-19.3', 'upperLimit': '-14.0'}, {'value': '-14.8', 'groupId': 'OG001', 'lowerLimit': '-17.4', 'upperLimit': '-12.2'}]}]}], 'analyses': [{'pValue': '0.171', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.8', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '0.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.29', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. The Skindex-10 has 10 questions; the total Skindex-10 score ranges from 0 to 60. A lower total score represents better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Itch Scale Score at the End of Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '236', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week'}, {'id': 'OG001', 'title': 'Double-blind Placebo', 'description': 'IV Placebo administered after each dialysis session (3 times/week)\n\nPlacebo: IV placebo administered three times/week'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.9', 'groupId': 'OG000', 'lowerLimit': '-5.6', 'upperLimit': '-4.2'}, {'value': '-3.8', 'groupId': 'OG001', 'lowerLimit': '-4.5', 'upperLimit': '-3.1'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-1.7', 'ciUpperLimit': '-0.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.35', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. The 5-D Itch Scale has 5 questions; the total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse responses.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week'}, {'id': 'FG001', 'title': 'Double-blind Placebo', 'description': 'IV Placebo administered after each dialysis session (3 times/week)\n\nPlacebo: IV placebo administered three times/week'}, {'id': 'FG002', 'title': 'Open-label CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week'}], 'periods': [{'title': 'Period 1: Double-blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '236'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '206'}, {'groupId': 'FG001', 'numSubjects': '223'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Eligibility (inclusion/exclusion criteria)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Subject non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 2: Open-label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '399'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '394'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '21'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Eligibility (inclusion/exclusion criteria)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Administrative', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '36'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'Sponsor stopping study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '313'}]}]}], 'preAssignmentDetails': 'The ITT Population consisted of 473 subjects randomized to study treatment, 237 to difelikefalin and 236 to placebo. The Double-blind Safety Population consisted of 471 randomized subjects who received at least 1 dose of double-blind study drug during the Double-blind Treatment Period; 235 of these subjects were treated with difelikefalin, and 236 were treated with placebo. Two subjects were randomized to difelikefalin but did not receive any study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}, {'value': '236', 'groupId': 'BG001'}, {'value': '471', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind CR845 0.5mcg/kg', 'description': 'IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)\n\nCR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week'}, {'id': 'BG001', 'title': 'Double-blind Placebo', 'description': 'IV Placebo administered after each dialysis session (3 times/week)\n\nPlacebo: IV placebo administered three times/week'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.7', 'spread': '13.11', 'groupId': 'BG000'}, {'value': '59.6', 'spread': '13.07', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '13.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '197', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '274', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '331', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-10', 'size': 3553728, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-21T14:57', 'hasProtocol': True}, {'date': '2020-03-09', 'size': 1823861, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-21T14:57', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 473}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'dispFirstSubmitDate': '2021-03-26', 'completionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-29', 'studyFirstSubmitDate': '2018-08-03', 'dispFirstSubmitQcDate': '2022-03-29', 'resultsFirstSubmitDate': '2021-09-21', 'studyFirstSubmitQcDate': '2018-08-15', 'dispFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-29', 'studyFirstPostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥3 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity Numerical Rating Scale (NRS) Score at Week 12', 'timeFrame': 'Week 12', 'description': 'Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". LS means estimated percent, odds ratio and P value used a logistic regression model.'}], 'secondaryOutcomes': [{'measure': 'Reduction of Itch Intensity as Assessed by the Percentage of Patients Achieving an Improvement From Baseline ≥4 Points With Respect to the Weekly Mean of the Daily 24-hour Worst Itching Intensity NRS Score at Week 12', 'timeFrame': 'Week 12', 'description': 'Intensity of itch will be measured using an NRS used to indicate the intensity of the worst itching over the past 24 hours using a 0 to 10 numeric rating scale, where "0" represents "no itching" and "10" represents "worst itching imaginable". LS means estimated percent, odds ratio and P value used a logistic regression model.'}, {'measure': 'Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in Total Skindex-10 Scale Score at the End of Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The Skindex-10 Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past week. The questions cover 3 domains: disease, mood/emotional distress, and social functioning domain. The Skindex-10 has 10 questions; the total Skindex-10 score ranges from 0 to 60. A lower total score represents better quality of life.'}, {'measure': 'Improvement in Itch-related Quality of Life as Assessed by the Change From Baseline in 5-D Itch Scale Score at the End of Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The 5-D Itch Scale is a multidimensional questionnaire which assesses itch-related quality of life over the past 2 weeks. The questions cover five dimensions of itch including the degree, duration of itch/day, direction (improvement/worsening), disability (impact on activities such as work), and body distribution of itch. The 5-D Itch Scale has 5 questions; the total 5-D Itch Scale score ranges from 5 to 25, with higher scores indicating worse responses.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'difelikefalin', 'CR845', 'Pruritus', 'Chronic Itch', 'Itch', 'Itching', 'Uremic Pruritus', 'Dialysis', 'CKD', 'CKD-associated pruritus', 'CKD-aP', 'ESRD (end stage renal disease)', 'KALM', 'Chronic Kidney Disease', 'Kidney failure, chronic', 'Kidney dysfunction', 'Generalized pruritus'], 'conditions': ['Uremic Pruritus']}, 'referencesModule': {'references': [{'pmid': '39037824', 'type': 'DERIVED', 'citation': 'Fishbane SN, Block GA, Evenepoel P, Budden J, Morin I, Menzaghi F, Wen W, Lerma EV. Pruritus Severity and Serum Phosphate in CKD: A Post Hoc Analysis of Difelikefalin Studies. Kidney360. 2024 Sep 1;5(9):1270-1280. doi: 10.34067/KID.0000000000000520. Epub 2024 Jul 22.'}, {'pmid': '37968132', 'type': 'DERIVED', 'citation': 'Weiner DE, Schaufler T, McCafferty K, Kalantar-Zadeh K, Germain M, Ruessmann D, Morin I, Menzaghi F, Wen W, Stander S. Difelikefalin improves itch-related sleep disruption in patients undergoing haemodialysis. Nephrol Dial Transplant. 2024 Jun 28;39(7):1125-1137. doi: 10.1093/ndt/gfad245.'}, {'pmid': '36039153', 'type': 'DERIVED', 'citation': 'Fishbane S, Wen W, Munera C, Lin R, Bagal S, McCafferty K, Menzaghi F, Goncalves J. Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program. Kidney Med. 2022 Jun 28;4(8):100513. doi: 10.1016/j.xkme.2022.100513. eCollection 2022 Aug.'}, {'pmid': '36016762', 'type': 'DERIVED', 'citation': 'Topf J, Wooldridge T, McCafferty K, Schomig M, Csiky B, Zwiech R, Wen W, Bhaduri S, Munera C, Lin R, Jebara A, Cirulli J, Menzaghi F. Efficacy of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis of KALM-1 and KALM-2 Phase 3 Studies. Kidney Med. 2022 Jun 28;4(8):100512. doi: 10.1016/j.xkme.2022.100512. eCollection 2022 Aug.'}, {'pmid': '33283264', 'type': 'DERIVED', 'citation': 'Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.', 'detailedDescription': 'Double-blind Phase: The Double-blind Phase of the study will consist of a Screening Visit, a 7-day Run-in Period, and a 12-week Double-blind Treatment Period. Informed consent will be obtained prior to performing any study-specific procedures. The Screening Visit will occur within 7 to 28 days prior to randomization to assess eligibility.\n\nOpen-label Extension Phase: Patients who received at least 30 doses of study drug (either active or placebo) during the 12-week Double-blind Treatment Period and continue to meet other eligibility criteria will have the option to receive open label CR845 for an additional 52 weeks.\n\nThe last dose of open-label study drug will be administered at the last dialysis visit on Week 52, or Early Termination.\n\nFollow-up Period: A final safety Follow up Visit will be conducted 7-10 days after the End of Treatment/Early Termination Visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nTo be eligible for inclusion into the Double-blind Phase of the study, a patient must meet the following criteria:\n\n* Has end-stage renal disease (ESRD) and has been on hemodialysis 3 times per week for at least 3 months prior to the start of screening;\n* Has at least 2 single-pool Kt/V measurements ≥1.2, or at least 2 urea reduction ratio measurements ≥65%, or 1 single pool Kt/V measurement ≥1.2 and 1 urea reduction ratio measurement ≥65% on different dialysis days during the 3 months period prior to screening;\n* Prior to randomization:\n\n * Has completed Worst Itching Intensity NRS worksheets up to 8 days prior to 1st dose;\n * Has a mean baseline Worst Itching Intensity NRS indicative of moderate to severe uremic pruritus.\n* To be eligible for inclusion into the Open-label Extension Phase of the study, each patient will have to fulfill the additional key following criteria at the time of entry into the Open-label Extension Phase:\n\n * Has received at least 30 doses of the planned 36 doses of study drug during the Double-blind Phase of this study;\n * Continues to meet inclusion criteria.\n\nKey Exclusion Criteria:\n\nA patient will be excluded from the Double-blind Phase of the study if any of the following criteria are met:\n\n* Known noncompliance with dialysis treatment that in the opinion of the investigator would impede completion or validity of the study;\n* Scheduled to receive a kidney transplant during the study;\n* New or change of treatment received for itch including antihistamines and corticosteroids (oral, IV, or topical) within 14 days prior to screening;\n* Received another investigational drug within 30 days prior to the start of screening or is planning to participate in another clinical study while enrolled in this study;\n* Has pruritus only during the dialysis session (by patient report);\n* Is receiving ongoing ultraviolet B and anticipates receiving such treatment during the study;\n* Participated in a previous clinical study with CR845.\n* A patient will be excluded from the Open-label Extension Phase of the study if any of the additional key following criteria are met at the time of entry into the Open-label Extension Phase:\n\n * Completed the Double-blind Phase of this study but exhibited adverse events during the course of the Treatment Period that may preclude continued exposure to the study drug;\n * Was noncompliant with protocol procedures during the Double-blind Phase of this study which is indicative of an inability to follow protocol procedures.'}, 'identificationModule': {'nctId': 'NCT03636269', 'acronym': 'KALM-2', 'briefTitle': 'CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cara Therapeutics, Inc.'}, 'officialTitle': 'A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus, With a 52-Week Open Label Extension', 'orgStudyIdInfo': {'id': 'CR845-CLIN3103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 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