Viewing Study NCT00860405

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Ignite Creation Date: 2025-12-25 @ 3:21 AM
Ignite Modification Date: 2026-01-06 @ 6:52 AM
Study NCT ID: NCT00860405
Status: COMPLETED
Last Update Posted: 2011-11-02
First Post: 2009-02-27
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Voluven® in Paediatric Patients
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': 'D006895', 'term': 'Hydroxyethyl Starch Derivatives'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C485123', 'term': 'HES 130-0.4'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D000075462', 'term': 'Serum Albumin, Human'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D012709', 'term': 'Serum Albumin'}, {'id': 'D000418', 'term': 'Albumins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'martin.westphal@fresenius-kabi.com', 'phone': '+49 6172 686 7280', 'title': 'Professor Dr. Martin Westphal, Chief Medical Officer', 'organization': 'Fresenius Kabi Aktiengesellschaft, Else-Kröner-Str. 1, 61352 Bad Homburg, Germany'}, 'certainAgreement': {'otherDetails': 'Publications are subject to a prior review of Fresenius Kabi and may only be made in a neutral and anonymous form within the respective circles of experts. Fresenius Kabi shall give its comments, if applicable, within 30 days after having received the respective manuscript. Manuscripts should be submitted for publication within 2 years following the final report.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event recording was performed throughout the study (from signing the informed consent until the follow-up visit at 28 days after discharge from operating room).', 'description': 'Regular assessment by Pharmacovigilance and Safety Assessor', 'eventGroups': [{'id': 'EG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.', 'otherNumAtRisk': 31, 'otherNumAffected': 30, 'seriousNumAtRisk': 31, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.', 'otherNumAtRisk': 29, 'otherNumAffected': 29, 'seriousNumAtRisk': 29, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cardiac aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Nodal rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Device occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Drug withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Exposure to contaminated device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Infusion site urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Enterobiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'H1n1 Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Post procedural pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Skin candida', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anaemia postoperative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cardiac procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Dilutional coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Procedural vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Traumatic haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Wound', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood lactic acid increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Enterovirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Venous oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hyperlactacidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypoproteinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Metabolic alkalosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Myoclonus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Phrenic nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Anuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Bradypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Increased bronchial secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Lung disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pulmonary congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Respiratory depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Stridor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pruritus allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}], 'seriousEvents': [{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Right ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Internal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Device breakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Medical device complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Lung infection pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Post procedural pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Postoperative wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Urinary tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Cardiac procedure complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Endotracheal intubation complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Apnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Chylothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Volume of Colloid Solution Required Intraoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '11.76', 'groupId': 'OG000'}, {'value': '36.97', 'spread': '11.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of LS-means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.16', 'pValueComment': 'Null hypothesis tested by calculating a 2-sided 95% CI for ratio of LS-means μVoluven/μHSA based on ANOVA incl.treatment+centre as effects. If 95% CI was within equivalence range(0.55, 1.82), significant equivalence was concluded (Type I error: 2.5%)', 'estimateComment': 'Considered ratio: μVoluven/μHSA = LS-mean of Voluven®/LS-mean of HSA 5%', 'groupDescription': 'The aim of the study was to prove equivalence, i.e. H0: μVoluven/μHSA ≤ 0.55 or μVoluven/μHSA ≥ 1.82 H1: 0.55 \\< μVoluven/μHSA \\< 1.82 where μVoluven was the mean infused volume of Voluven® and μHSA was the mean infused volume of HSA 5%.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Primary endpoint specified + analysed for PP and ITT population. Confirmatory analysis based on PP population only, no adjustment for multiplicity.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Assuming a coefficient of variation of 0.363 and a desired power of 90 % with a type I level of 2.5 %, N=11 patients per treatment group were needed. The power was calculated by means of the software SAS, version 9.1.3, PROC POWER. Nevertheless, more patients were required for the assessment of safety, therefore 2 × 30 patients were planned to be included in this study.'}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 (intraoperatively)', 'description': 'Total volume of study drug plus rescue colloid, if applicable', 'unitOfMeasure': 'ml/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population (PP) = All patients in the Intention-to-treat (ITT) set without any major protocol violation.'}, {'type': 'SECONDARY', 'title': 'Mean Arterial Pressure (MAP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'title': 'T0, Baseline', 'categories': [{'measurements': [{'value': '64.1', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '66.5', 'spread': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'T1, before ECC (Extracorporeal circulation)', 'categories': [{'measurements': [{'value': '54.0', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '51.3', 'spread': '8.0', 'groupId': 'OG001'}]}]}, {'title': 'T2, after ECC', 'categories': [{'measurements': [{'value': '56.6', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '58.2', 'spread': '9.7', 'groupId': 'OG001'}]}]}, {'title': 'T3, after skin closure', 'categories': [{'measurements': [{'value': '61.2', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '62.0', 'spread': '9.9', 'groupId': 'OG001'}]}]}, {'title': 'T4, arrival on ICU', 'categories': [{'measurements': [{'value': '65.3', 'spread': '14.8', 'groupId': 'OG000'}, {'value': '65.2', 'spread': '8.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)', 'description': 'Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population (PP) = All patients in the ITT set without any major protocol violation'}, {'type': 'SECONDARY', 'title': 'Fluid Input', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'categories': [{'measurements': [{'value': '246.8', 'spread': '119.3', 'groupId': 'OG000'}, {'value': '248.2', 'spread': '105.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning', 'unitOfMeasure': 'ml/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population (PP) = All patients in the ITT set without any major protocol violation'}, {'type': 'SECONDARY', 'title': 'Fluid Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'categories': [{'measurements': [{'value': '195.5', 'spread': '95.7', 'groupId': 'OG000'}, {'value': '181.1', 'spread': '68.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning', 'unitOfMeasure': 'ml/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.'}, {'type': 'SECONDARY', 'title': 'Fluid Balance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.3', 'spread': '47.5', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '62.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Balance of total fluid input and total fluid output', 'unitOfMeasure': 'ml/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-protocol population (PP) = All patients in the ITT set without any major protocol violation.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Calculated Perioperative Red Blood Cell (RBC) Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '15.3', 'spread': '15.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days', 'description': 'Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit \\[baseline\\] - hematocrit \\[2nd postop morning\\]) + transfused RBC volume2;\n\n1. Predicted blood volume (mL) = 80 × body weight (kg)\n2. Transfused RBC volume = 0.7 × infused packed RBC', 'unitOfMeasure': 'ml/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population (SAF) = All randomized patients treated with study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Length of Stay on the Intensive Care Unit (ICU)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.8'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '6.9'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From admission to ICU until discharge from ICU', 'description': 'Length of stay (number of days) on the intensive care unit (ICU).', 'unitOfMeasure': 'Days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population (SAF) = All randomized patients treated with study drug.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From screening to end of follow-up', 'description': 'Mortality was reported for the time period from screening until the end of follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population (SAF) = All randomized patients treated with study drug'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Acute Renal Failure (ARF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'OG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline until 2nd postop morning.', 'description': 'Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population (SAF) = All randomized patients treated with study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'FG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'Completed Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Day 28 Follow-up Performed', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'completed overall study', 'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Main reason: Follow-up data not complete', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'Participants were recruited in paediatric care units of 2 hospitals in Austria and Belgium from March 2009 (FPI) until July 2010 and were followed up until August 2010 (LPO).', 'preAssignmentDetails': 'Participants were screened in paediatric care units of the participating 2 study sites in Austria and Belgium.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Voluven® Arm', 'description': '6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.'}, {'id': 'BG001', 'title': 'HSA 5% Arm (Comparison Group)', 'description': 'Human Serum Albumin (HSA) 50g/L, i.v.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '2.9', 'groupId': 'BG000'}, {'value': '4.0', 'spread': '2.0', 'groupId': 'BG001'}, {'value': '4.6', 'spread': '2.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '18.2', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '15.4', 'spread': '4.4', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '7.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '106.6', 'spread': '16.8', 'groupId': 'BG000'}, {'value': '101.3', 'spread': '12.8', 'groupId': 'BG001'}, {'value': '104.0', 'spread': '15.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-01', 'studyFirstSubmitDate': '2009-02-27', 'resultsFirstSubmitDate': '2011-08-12', 'studyFirstSubmitQcDate': '2009-03-11', 'lastUpdatePostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-12', 'studyFirstPostDateStruct': {'date': '2009-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Calculated Perioperative Red Blood Cell (RBC) Loss', 'timeFrame': '2 days', 'description': 'Calculated perioperative RBC loss = Predicted blood volume1 × (hematocrit \\[baseline\\] - hematocrit \\[2nd postop morning\\]) + transfused RBC volume2;\n\n1. Predicted blood volume (mL) = 80 × body weight (kg)\n2. Transfused RBC volume = 0.7 × infused packed RBC'}, {'measure': 'Length of Stay on the Intensive Care Unit (ICU)', 'timeFrame': 'From admission to ICU until discharge from ICU', 'description': 'Length of stay (number of days) on the intensive care unit (ICU).'}, {'measure': 'Mortality', 'timeFrame': 'From screening to end of follow-up', 'description': 'Mortality was reported for the time period from screening until the end of follow-up.'}, {'measure': 'Acute Renal Failure (ARF)', 'timeFrame': 'From baseline until 2nd postop morning.', 'description': 'Acute renal failure was defined as a two fold increase in serum creatinine concentration over the value at baseline at any time after baseline.'}], 'primaryOutcomes': [{'measure': 'Total Volume of Colloid Solution Required Intraoperatively', 'timeFrame': 'Day 1 (intraoperatively)', 'description': 'Total volume of study drug plus rescue colloid, if applicable'}], 'secondaryOutcomes': [{'measure': 'Mean Arterial Pressure (MAP)', 'timeFrame': 'Beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)', 'description': 'Mean arterial pressure (MAP) from beginning of anaesthesia (baseline) until arrival on intensive care unit (ICU)'}, {'measure': 'Fluid Input', 'timeFrame': '2 days', 'description': 'Quantity of total fluids administered from beginning of anaesthesia until 2nd postop morning'}, {'measure': 'Fluid Output', 'timeFrame': '2 days', 'description': 'Quantity of total fluids excreted or lost from beginning of anaesthesia until 2nd postop morning'}, {'measure': 'Fluid Balance', 'timeFrame': '2 days', 'description': 'Balance of total fluid input and total fluid output'}]}, 'conditionsModule': {'conditions': ['Cardiac Surgery', 'Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.', 'detailedDescription': 'In the past, human albumin has been widely accepted as the therapeutic "gold standard" in paediatric volume replacement therapy because of the physiological hypoproteinemia in newborns and infants. In adult patients, artificial colloids such as hydroxyethyl starch have replaced human albumin as first choice in many settings. This study will compare the clinical efficacy and safety of HES 130/0.4 (6%) in normal saline vs. HSA 50g/L in volume replacement therapy during elective open-heart surgery in paediatric patients. The hypothesis of this study is to demonstrate that HES 130/0.4 (6%) and HSA 50g/L are equivalent regarding efficacy and provide comparable safety during elective open-heart surgery in paediatric patients 2 to 12 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female paediatric patient, 2 to 12 years of age, suffering from congenital heart-disease and undergoing elective open-heart surgery requiring ECC;\n* Signed parental written informed consent and patient assent where achievable\n\nExclusion Criteria:\n\n* Known contraindication against scheduled concomitant medication;\n* Total ECC volume \\< 400 mL;\n* ASA \\> III'}, 'identificationModule': {'nctId': 'NCT00860405', 'briefTitle': 'Voluven® in Paediatric Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Efficacy and Safety of 6 % Hydroxyethyl Starch 130/0.4 (Voluven®) vs. 5% HSA in Volume Replacement Therapy During Elective Open-heart Surgery in Paediatric Patients', 'orgStudyIdInfo': {'id': 'HE06-001-C P4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Investigational drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion)', 'interventionNames': ['Drug: HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Control drug: Human serum albumin (HSA 50g/L)', 'interventionNames': ['Drug: Human serum albumin (HSA 50g/L)']}], 'interventions': [{'name': 'HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L)', 'type': 'DRUG', 'otherNames': ['Voluven®'], 'description': 'Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day.', 'armGroupLabels': ['1']}, {'name': 'Human serum albumin (HSA 50g/L)', 'type': 'DRUG', 'description': 'Human serum albumin (HSA 50g/L)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4021', 'city': 'Linz', 'country': 'Austria', 'facility': 'AKh Allgemeines Krankenhaus der Stadt Linz GmbH', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'HUDERF - Hôpital Universitaire des Enfants Reine Fabiola', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Philippe Van der Linden, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUDERF - Hôpital Universitaire des Enfants Reine Fabiola'}, {'name': 'Hans Gombotz, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AKh Allgemeines Krankenhaus der Stadt Linz GmbH'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}