Viewing Study NCT05876351

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-24 @ 11:53 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
Study NCT ID: NCT05876351
Status: COMPLETED
Last Update Posted: 2025-12-08
First Post: 2023-05-17
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C481642', 'term': 'eculizumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@alexion.com', 'phone': '+1.855.752.2356', 'title': 'Alexion Pharmaceuticals Inc.', 'organization': 'European Clinical Trial Information'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to Week 34', 'description': 'Safety Set: Included all participants who received at least 1 dose of study intervention.', 'eventGroups': [{'id': 'EG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 24, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'seriousEvents': [{'term': 'Bacterial infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Rotavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Retching', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}, {'term': 'Synovial cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With a Complete Thrombotic Microangiopathy (TMA) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.0', 'spread': '42.5', 'groupId': 'OG000', 'lowerLimit': '42.5', 'upperLimit': '82.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 26', 'description': 'The criteria for complete TMA response were:\n\n1. Normalization of platelet count (defined as platelet count ≥ 150000/microliter (ul).\n2. Normalization of lactate dehydrogenase (LDH, defined as LDH ≤ upper limit of normal \\[ULN\\]).\n3. ≥ 25% improvement in serum creatinine from baseline.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 34', 'description': "An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.\n\nA serious AE (SAE) was defined as any untoward medical occurrence that, at any dose:\n\n* resulted in death,\n* was life-threatening,\n* required inpatient hospitalization or prolongation of existing hospitalization,\n* resulted in persistent disability/incapacity,\n* was a congenital anomaly/birth defect, or\n* was an important medical event.\n\nA summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Adverse Events' Section.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: Included all participants who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Mean Serum Concentration of Eculizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Day 1: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.690', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Day 1: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '373.423', 'spread': '47.59', 'groupId': 'OG000'}]}]}, {'title': 'Day 8: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '153.190', 'spread': '69.69', 'groupId': 'OG000'}]}]}, {'title': 'Day 8: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '498.262', 'spread': '41.18', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '353.726', 'spread': '36.96', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '727.862', 'spread': '32.22', 'groupId': 'OG000'}]}]}, {'title': 'Day 85: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '360.070', 'spread': '43.89', 'groupId': 'OG000'}]}]}, {'title': 'Day 85: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '728.624', 'spread': '42.04', 'groupId': 'OG000'}]}]}, {'title': 'Day 141: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '433.737', 'spread': '41.32', 'groupId': 'OG000'}]}]}, {'title': 'Day 141: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '883.675', 'spread': '38.74', 'groupId': 'OG000'}]}]}, {'title': 'Day 183: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '434.739', 'spread': '38.66', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and post-dose at Days 1, 8, 29, 85, and 141; Pre-dose at Day 183', 'unitOfMeasure': 'micrograms per milliliter (ug/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacokinetic (PK) Analysis Set: Included all participants who received at least 1 dose of study intervention and had evaluable pharmacokinetic data. 'Number Analyzed' = number of participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Free Complement 5 (C5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Day 1: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-79.8842', 'spread': '17.5197', 'groupId': 'OG000'}]}]}, {'title': 'Day 8: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-79.6539', 'spread': '17.8589', 'groupId': 'OG000'}]}]}, {'title': 'Day 8: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-79.6636', 'spread': '17.8610', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-80.4277', 'spread': '17.1241', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-80.4284', 'spread': '17.1241', 'groupId': 'OG000'}]}]}, {'title': 'Day 85: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-80.0632', 'spread': '17.3489', 'groupId': 'OG000'}]}]}, {'title': 'Day 85: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-80.0632', 'spread': '17.3489', 'groupId': 'OG000'}]}]}, {'title': 'Day 141: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-80.0625', 'spread': '17.3485', 'groupId': 'OG000'}]}]}, {'title': 'Day 141: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-80.0632', 'spread': '17.3489', 'groupId': 'OG000'}]}]}, {'title': 'Day 183: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-80.0632', 'spread': '17.3489', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 pre-dose) to Days 1, 8, 29, 85 and 141 (pre-dose and post-dose) and pre-dose at Day 183', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic (PD) Analysis Set: Included all participants who received at least 1 dose of study intervention and had evaluable PD data. 'Number Analyzed' = number of participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Total C5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Day 1: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-12.0267', 'spread': '6.1396', 'groupId': 'OG000'}]}]}, {'title': 'Day 8: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.9293', 'spread': '21.3162', 'groupId': 'OG000'}]}]}, {'title': 'Day 8: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.2831', 'spread': '23.0175', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.9100', 'spread': '25.0734', 'groupId': 'OG000'}]}]}, {'title': 'Day 29: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.4783', 'spread': '22.7695', 'groupId': 'OG000'}]}]}, {'title': 'Day 85: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.2418', 'spread': '25.7350', 'groupId': 'OG000'}]}]}, {'title': 'Day 85: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '66.5267', 'spread': '26.7232', 'groupId': 'OG000'}]}]}, {'title': 'Day 141: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.8284', 'spread': '25.3689', 'groupId': 'OG000'}]}]}, {'title': 'Day 141: Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.0693', 'spread': '23.1231', 'groupId': 'OG000'}]}]}, {'title': 'Day 183: Pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '78.5497', 'spread': '27.1158', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1 pre-dose) to Days 1, 8, 29, 85 and 141 (pre-dose and post-dose) and pre-dose at Day 183', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD Analysis Set: Included all participants who received at least 1 dose of study intervention and had evaluable PD data. 'Number Analyzed' = number of participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Number of Participants With an Anti-drug Antibody (ADA) Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to Week 26', 'description': 'An ADA response was defined as a positive ADA sample at any time during the study.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Set: Included all participants who received at least 1 dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Time to Complete TMA Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.0', 'comment': 'Upper limit was not reached due to limited number of events.', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to Week 26', 'description': 'Time to complete TMA response was defined as the time from first infusion to the first time point at which all criteria for complete TMA response was met.\n\nThe criteria for complete TMA response were:\n\n1. Normalization of platelet count (defined as platelet count ≥ 150000/ul.\n2. Normalization of LDH, defined as LDH ≤ ULN).\n3. ≥ 25% improvement in serum creatinine from baseline.\n\nParticipants who did not have a response were censored at the date of last visit or study discontinuation at the time when the analysis was performed.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose.'}, {'type': 'SECONDARY', 'title': 'Proportion of Participants On or Off Dialysis at Each Timepoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Baseline: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.440', 'groupId': 'OG000', 'lowerLimit': '0.244', 'upperLimit': '0.651'}]}]}, {'title': 'Baseline: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.560', 'groupId': 'OG000', 'lowerLimit': '0.349', 'upperLimit': '0.756'}]}]}, {'title': 'Day 22: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.261', 'groupId': 'OG000', 'lowerLimit': '0.102', 'upperLimit': '0.484'}]}]}, {'title': 'Day 22: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.739', 'groupId': 'OG000', 'lowerLimit': '0.516', 'upperLimit': '0.898'}]}]}, {'title': 'Day 43: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.235', 'groupId': 'OG000', 'lowerLimit': '0.068', 'upperLimit': '0.499'}]}]}, {'title': 'Day 43: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.765', 'groupId': 'OG000', 'lowerLimit': '0.501', 'upperLimit': '0.932'}]}]}, {'title': 'Day 71: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.211', 'groupId': 'OG000', 'lowerLimit': '0.061', 'upperLimit': '0.456'}]}]}, {'title': 'Day 71: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.789', 'groupId': 'OG000', 'lowerLimit': '0.544', 'upperLimit': '0.939'}]}]}, {'title': 'Day 99: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.176', 'groupId': 'OG000', 'lowerLimit': '0.038', 'upperLimit': '0.434'}]}]}, {'title': 'Day 99: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.824', 'groupId': 'OG000', 'lowerLimit': '0.566', 'upperLimit': '0.962'}]}]}, {'title': 'Day 113: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.167', 'groupId': 'OG000', 'lowerLimit': '0.036', 'upperLimit': '0.414'}]}]}, {'title': 'Day 113: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.833', 'groupId': 'OG000', 'lowerLimit': '0.586', 'upperLimit': '0.964'}]}]}, {'title': 'Day 127: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.111', 'groupId': 'OG000', 'lowerLimit': '0.014', 'upperLimit': '0.347'}]}]}, {'title': 'Day 127: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.889', 'groupId': 'OG000', 'lowerLimit': '0.653', 'upperLimit': '0.986'}]}]}, {'title': 'Day 155: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.167', 'groupId': 'OG000', 'lowerLimit': '0.036', 'upperLimit': '0.414'}]}]}, {'title': 'Day 155: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.833', 'groupId': 'OG000', 'lowerLimit': '0.586', 'upperLimit': '0.964'}]}]}, {'title': 'Day 183: On Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.167', 'groupId': 'OG000', 'lowerLimit': '0.036', 'upperLimit': '0.414'}]}]}, {'title': 'Day 183: Off Dialysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.833', 'groupId': 'OG000', 'lowerLimit': '0.586', 'upperLimit': '0.964'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Days 22, 43, 71, 99, 113, 127, 155 and 183', 'description': "Participants were considered as 'off' dialysis at a specific time point if they were dialysis free for more than 5 days prior to that time point. Participants were considered as 'on' dialysis at a specific time point if they were dialysis free to 5 days or less up prior to that time point.", 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Number Analyzed' = number of participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Each Scheduled Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39.82', 'spread': '50.83', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.72', 'spread': '44.75', 'groupId': 'OG000'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.33', 'spread': '47.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.53', 'spread': '47.17', 'groupId': 'OG000'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.88', 'spread': '45.38', 'groupId': 'OG000'}]}]}, {'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.85', 'spread': '48.01', 'groupId': 'OG000'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.33', 'spread': '49.32', 'groupId': 'OG000'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.29', 'spread': '44.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 71, 99, 113, 127, 155 and 183', 'description': 'Expressed in milliliters per minute per 1.73 square meters of body surface area.', 'unitOfMeasure': 'mL/min/1.73^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Number Analyzed' = number of participants evaluable at the specific timepoint. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specific timepoint."}, {'type': 'SECONDARY', 'title': 'Proportion of Participants With a Chronic Kidney Disease (CKD) Stage Shift Categorized as "Improved", "Stable", or "Worsened" at Each Scheduled Visit Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Day 22: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.545', 'groupId': 'OG000', 'lowerLimit': '0.322', 'upperLimit': '0.756'}]}]}, {'title': 'Day 22: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.455', 'groupId': 'OG000', 'lowerLimit': '0.244', 'upperLimit': '0.678'}]}]}, {'title': 'Day 22: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.410'}]}]}, {'title': 'Day 43: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.688', 'groupId': 'OG000', 'lowerLimit': '0.413', 'upperLimit': '0.890'}]}]}, {'title': 'Day 43: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.313', 'groupId': 'OG000', 'lowerLimit': '0.110', 'upperLimit': '0.587'}]}]}, {'title': 'Day 43: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.602'}]}]}, {'title': 'Day 71: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.722', 'groupId': 'OG000', 'lowerLimit': '0.465', 'upperLimit': '0.903'}]}]}, {'title': 'Day 71: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.278', 'groupId': 'OG000', 'lowerLimit': '0.097', 'upperLimit': '0.535'}]}]}, {'title': 'Day 71: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.522'}]}]}, {'title': 'Day 99: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.750', 'groupId': 'OG000', 'lowerLimit': '0.476', 'upperLimit': '0.927'}]}]}, {'title': 'Day 99: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000', 'lowerLimit': '0.073', 'upperLimit': '0.524'}]}]}, {'title': 'Day 99: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.522'}]}]}, {'title': 'Day 113: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.765', 'groupId': 'OG000', 'lowerLimit': '0.501', 'upperLimit': '0.932'}]}]}, {'title': 'Day 113: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.235', 'groupId': 'OG000', 'lowerLimit': '0.068', 'upperLimit': '0.499'}]}]}, {'title': 'Day 113: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.459'}]}]}, {'title': 'Day 127: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.765', 'groupId': 'OG000', 'lowerLimit': '0.501', 'upperLimit': '0.932'}]}]}, {'title': 'Day 127: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.235', 'groupId': 'OG000', 'lowerLimit': '0.068', 'upperLimit': '0.499'}]}]}, {'title': 'Day 127: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.459'}]}]}, {'title': 'Day 155: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.875', 'groupId': 'OG000', 'lowerLimit': '0.617', 'upperLimit': '0.984'}]}]}, {'title': 'Day 155: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.125', 'groupId': 'OG000', 'lowerLimit': '0.016', 'upperLimit': '0.383'}]}]}, {'title': 'Day 155: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.522'}]}]}, {'title': 'Day 183: Improved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.824', 'groupId': 'OG000', 'lowerLimit': '0.566', 'upperLimit': '0.962'}]}]}, {'title': 'Day 183: Stable', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.176', 'groupId': 'OG000', 'lowerLimit': '0.038', 'upperLimit': '0.434'}]}]}, {'title': 'Day 183: Worsened', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0.522'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Days 22, 43, 71, 99, 113, 127, 155 and 183', 'description': 'CKD stage was classified based on the National Kidney Foundation Chronic Kidney Disease Stage where Stage 5 represents the most severe disease and Stage 1 represents the least severe disease.\n\n"Improved" excluded participants with Stage 1 at baseline as there was no room for improvement. "Worsened" excludes participants with Stage 5 at baseline as there was no room to worsen.', 'unitOfMeasure': 'proportion of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Platelets', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.5', 'spread': '117.7', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.5', 'spread': '90.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.3', 'spread': '97.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.4', 'spread': '68.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.1', 'spread': '82.7', 'groupId': 'OG000'}]}]}, {'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.8', 'spread': '86.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.8', 'spread': '98.2', 'groupId': 'OG000'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.3', 'spread': '98.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183', 'description': 'Platelet values obtained from the day of a blood transfusion of platelets through 3 days after the transfusion are excluded from all analysis.', 'unitOfMeasure': '10^9 platelets/liter (L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in LDH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.445', 'spread': '12.459', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-6.147', 'spread': '10.175', 'groupId': 'OG000'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-7.083', 'spread': '10.099', 'groupId': 'OG000'}]}]}, {'title': 'Day 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.861', 'spread': '8.356', 'groupId': 'OG000'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.769', 'spread': '8.041', 'groupId': 'OG000'}]}]}, {'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.444', 'spread': '8.314', 'groupId': 'OG000'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.848', 'spread': '8.478', 'groupId': 'OG000'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.680', 'spread': '8.172', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183', 'unitOfMeasure': 'microkatal per liter (ukat/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'classes': [{'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.0', 'spread': '18.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.7', 'spread': '20.1', 'groupId': 'OG000'}]}]}, {'title': 'Day 71', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.5', 'spread': '22.6', 'groupId': 'OG000'}]}]}, {'title': 'Day 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.3', 'spread': '19.3', 'groupId': 'OG000'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.8', 'spread': '17.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 127', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.2', 'spread': '16.4', 'groupId': 'OG000'}]}]}, {'title': 'Day 155', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.5', 'spread': '14.9', 'groupId': 'OG000'}]}]}, {'title': 'Day 183', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.2', 'spread': '15.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183', 'description': 'Hemoglobin values obtained from the day of a blood transfusion of either whole blood or packed red blood cells through 7 days after the transfusion are excluded from all analysis.', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose. 'Overall number of participants analyzed' = participants evaluable for this outcome measure. 'Number Analyzed' = number of participants evaluable at the specific timepoint."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an intravenous (IV) infusion at a dose and schedule according to body weight for 26 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Study specific discontinuation criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'After providing informed consent/assent, participants were screened for eligibility for the study during the 7-day Screening Period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Eculizumab', 'description': 'Participants received eculizumab as an IV infusion at a dose and schedule according to body weight for 26 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '23.40', 'spread': '15.95', 'groupId': 'BG000', 'lowerLimit': '15.95'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': 'In utero', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Preterm newborn infants (gestational age < 37 wks)', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Newborns (0-27 days)', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Infants and toddlers (28 days-23 months)', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Children (2-11 years)', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Adolescents (12-17 years)', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Adults (18-64 years)', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'From 65-84 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '85 years and over', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis Set: Included all participants who received at least 1 dose of study intervention and had at least 1 efficacy assessment post first dose.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-26', 'size': 824742, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-11-05T15:25', 'hasProtocol': True}, {'date': '2025-05-20', 'size': 501180, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-11-05T15:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open-label study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2023-05-17', 'resultsFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2023-05-17', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-05', 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With a Complete Thrombotic Microangiopathy (TMA) Response', 'timeFrame': 'Up to Week 26', 'description': 'The criteria for complete TMA response were:\n\n1. Normalization of platelet count (defined as platelet count ≥ 150000/microliter (ul).\n2. Normalization of lactate dehydrogenase (LDH, defined as LDH ≤ upper limit of normal \\[ULN\\]).\n3. ≥ 25% improvement in serum creatinine from baseline.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With an Adverse Event (AE)', 'timeFrame': 'Up to Week 34', 'description': "An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.\n\nA serious AE (SAE) was defined as any untoward medical occurrence that, at any dose:\n\n* resulted in death,\n* was life-threatening,\n* required inpatient hospitalization or prolongation of existing hospitalization,\n* resulted in persistent disability/incapacity,\n* was a congenital anomaly/birth defect, or\n* was an important medical event.\n\nA summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Adverse Events' Section."}, {'measure': 'Mean Serum Concentration of Eculizumab', 'timeFrame': 'Pre-dose and post-dose at Days 1, 8, 29, 85, and 141; Pre-dose at Day 183'}, {'measure': 'Change From Baseline in Serum Free Complement 5 (C5)', 'timeFrame': 'Baseline (Day 1 pre-dose) to Days 1, 8, 29, 85 and 141 (pre-dose and post-dose) and pre-dose at Day 183'}, {'measure': 'Change From Baseline in Serum Total C5', 'timeFrame': 'Baseline (Day 1 pre-dose) to Days 1, 8, 29, 85 and 141 (pre-dose and post-dose) and pre-dose at Day 183'}, {'measure': 'Number of Participants With an Anti-drug Antibody (ADA) Response', 'timeFrame': 'Up to Week 26', 'description': 'An ADA response was defined as a positive ADA sample at any time during the study.'}, {'measure': 'Time to Complete TMA Response', 'timeFrame': 'Up to Week 26', 'description': 'Time to complete TMA response was defined as the time from first infusion to the first time point at which all criteria for complete TMA response was met.\n\nThe criteria for complete TMA response were:\n\n1. Normalization of platelet count (defined as platelet count ≥ 150000/ul.\n2. Normalization of LDH, defined as LDH ≤ ULN).\n3. ≥ 25% improvement in serum creatinine from baseline.\n\nParticipants who did not have a response were censored at the date of last visit or study discontinuation at the time when the analysis was performed.'}, {'measure': 'Proportion of Participants On or Off Dialysis at Each Timepoint', 'timeFrame': 'Baseline and Days 22, 43, 71, 99, 113, 127, 155 and 183', 'description': "Participants were considered as 'off' dialysis at a specific time point if they were dialysis free for more than 5 days prior to that time point. Participants were considered as 'on' dialysis at a specific time point if they were dialysis free to 5 days or less up prior to that time point."}, {'measure': 'Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Each Scheduled Visit', 'timeFrame': 'Baseline, Days 22, 43, 71, 99, 113, 127, 155 and 183', 'description': 'Expressed in milliliters per minute per 1.73 square meters of body surface area.'}, {'measure': 'Proportion of Participants With a Chronic Kidney Disease (CKD) Stage Shift Categorized as "Improved", "Stable", or "Worsened" at Each Scheduled Visit Compared to Baseline', 'timeFrame': 'Baseline to Days 22, 43, 71, 99, 113, 127, 155 and 183', 'description': 'CKD stage was classified based on the National Kidney Foundation Chronic Kidney Disease Stage where Stage 5 represents the most severe disease and Stage 1 represents the least severe disease.\n\n"Improved" excluded participants with Stage 1 at baseline as there was no room for improvement. "Worsened" excludes participants with Stage 5 at baseline as there was no room to worsen.'}, {'measure': 'Change From Baseline in Platelets', 'timeFrame': 'Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183', 'description': 'Platelet values obtained from the day of a blood transfusion of platelets through 3 days after the transfusion are excluded from all analysis.'}, {'measure': 'Change From Baseline in LDH', 'timeFrame': 'Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183'}, {'measure': 'Change From Baseline in Hemoglobin', 'timeFrame': 'Baseline, Days 22, 43, 71, 99, 113, 127, 155, and 183', 'description': 'Hemoglobin values obtained from the day of a blood transfusion of either whole blood or packed red blood cells through 7 days after the transfusion are excluded from all analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['atypical hemolytic uremic', 'aHUS'], 'conditions': ['Atypical Hemolytic Uremic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D7413C00001&amp;attachmentIdentifier=1484821e-7ae9-457c-81aa-263cc2c205e5&amp;fileName=Synopsis_ECU-aHUS-302_CSR_body_V1.0_-_signed_Redacted.pdf&amp;versionIdentifier=', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3b, open-label, single-arm, multicenter study to evaluate the efficacy and safety of eculizumab in participants with atypical hemolytic uremic syndrome (aHUS) in China', 'detailedDescription': 'This is a Phase 3b, open-label, single-arm, multicenter study to evaluate the efficacy and safety of eculizumab in participants with aHUS in China. The study will be conducted in participants of any age who weigh ≥ 5 kg and who previously have not been treated with complement inhibitors. The study consists of an up to 7-day Screening Period and a 26-week Treatment Period. An 8-week Safety Follow-up Phone Call will be required only for participants who discontinue eculizumab treatment during the study or for participants who will not receive continued access to eculizumab after completing study treatment. Approximately 25 eligible participants in China will be enrolled.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any age weighing ≥ 5 kg\n2. Complement treatment naïve with evidence of TMA.\n3. History of aHUS prior to kidney transplant,or persistent evidence of TMA at least 4 days after modifying the immunosuppressive regimen.\n4. Among participants with onset of TMA postpartum, persistent evidence of TMA for \\> 3 days after the day of childbirth\n5. All participants must be vaccinated against N meningitidis if not already vaccinated within the time period of active coverage specified by the vaccine manufacturer.\n6. Participants \\< 18 years of age must have been vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to local vaccination schedule guidelines.\n7. In participants receiving treatment with medications known to cause TMA, persistent evidence of TMA at least 4 days after modifying the excluded medication\n\nExclusion Criteria:\n\n1. Known familial or acquired ADAMTS13deficiency (activity \\< 5%).\n2. ST-HUS as demonstrated by local guidelines.\n3. Positive direct Coombs test which is indicative of a clinically significant immune-mediated hemolysis not due to aHUS.\n4. HIV infection, and /or unresolved meningococcal disease\n5. Ongoing sepsis, and / or presence or suspicion of active and untreated systemic infection\n6. Organ transplantation history, and/or Bone marrow transplant/hematopoietic stem cell transplant within 6 months prior to the start of Screening.\n7. Among participants with a kidney transplant, acute kidney dysfunction within 4 weeks of transplant consistent with the diagnosis of acute antibody-mediated rejection.\n8. Among participants without a kidney transplant, history of kidney disease other than aHUS\n9. Identified drug exposure-related HUS, and / or HUS related to vitamin B12 deficiency and / or known genetic defects of cobalamin C metabolism.\n10. History of malignancy within 5 years of Screening.\n11. Known systemic sclerosis (scleroderma), systemic lupus erythematosus, or antiphospholipid antibody positivity or syndrome.\n12. Chronic dialysis.\n13. Prior use of complement inhibitors.\n14. Use of tranexamic acid within 7 days prior to the start of Screening.\n15. Other immunosuppressive therapies.\n16. Receiving chronic intravenous immunoglobulin (IVIg) within 8 weeks prior to the start of Screening.\n17. Received vasopressors or inotropes within 7 days prior to Screening.\n18. Previously or currently treated with a complement inhibitor.\n19. Has participated in another interventional treatment study or used any experimental therapy.\n20. Hypersensitivity to any excipient in eculizumab.\n21. Pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05876351', 'acronym': 'Soliris', 'briefTitle': 'Eculizumab in Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'Prospective, Single-Arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment-Naïve Pediatric and Adult Participants With Atypical Hemolytic Uremic Syndrome (aHUS) in China', 'orgStudyIdInfo': {'id': 'D7413C00001'}, 'secondaryIdInfos': [{'id': 'ECU-aHUS-302', 'type': 'OTHER', 'domain': 'Alexion'}, {'id': '2025-000162-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eculizumab', 'description': 'Participants will receive Eculizumab in a single dose vial.', 'interventionNames': ['Drug: Eculizumab']}], 'interventions': [{'name': 'Eculizumab', 'type': 'DRUG', 'description': 'Weight-based doses of Eculizumab will be administered intravenously as an induction dose followed by maintenance dose at Day 8, 15, or 29 depending on weight; then every 2 or 3 weeks, depending upon weight.', 'armGroupLabels': ['Eculizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100045', 'city': 'Beijing', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '410007', 'city': 'Changsha', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '110016', 'city': 'Qingdao', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.06488, 'lon': 120.38042}}, {'zip': '030012', 'city': 'Taiyuan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '430030', 'city': 'Wuhan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}