Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2026-01-07 @ 7:20 AM
Study NCT ID:
NCT00478192
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2007-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007010', 'term': 'Hyponatremia'}, {'id': 'D004487', 'term': 'Edema'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C106389', 'term': 'conivaptan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@us.astellas.com', 'title': 'Senior Medical Director, Medical Affairs', 'organization': 'Astellas Pharma Global Development'}, 'certainAgreement': {'otherDetails': "Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript at least 30 days prior to publication to ensure that no confidential information of Sponsor is included in the document. Sponsor may delay the publication for an additional 60 days to seek patent protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Company makes no warranties or representations of any kind as to the currency or completeness of the posting, expressed or implied, including warranties of merchantability and fitness for a particular purpose and shall not be liable for any damages.'}}, 'adverseEventsModule': {'description': 'An Adverse Event was defined as treatment emergent if it occurred after the first dose of study drug through the ninth day after the last dose.\n\nParticipants at Risk represent the Safety Analysis Set.', 'eventGroups': [{'id': 'EG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day', 'otherNumAtRisk': 20, 'otherNumAffected': 7, 'seriousNumAtRisk': 20, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day', 'otherNumAtRisk': 20, 'otherNumAffected': 10, 'seriousNumAtRisk': 20, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Regimen 3 Placebo', 'otherNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypocoagulable state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ventricular arrthmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypothyrodism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bowel sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Bronchitis chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Blood creatine phosphokinaise increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Blood presure decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Breath sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac murmur', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Carotid bruit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Chest X-ray abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Heart sounds abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypervolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Postnasal drip', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Rales', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Rhinitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'seriousEvents': [{'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Multi-organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Coronary artery bypass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'OG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'OG002', 'title': 'Regimen 3 Placebo'}], 'classes': [{'title': 'Baseline (N= 20; 20; 9)', 'categories': [{'measurements': [{'value': '126.03', 'spread': '4.017', 'groupId': 'OG000'}, {'value': '126.39', 'spread': '3.581', 'groupId': 'OG001'}, {'value': '125.55', 'spread': '3.648', 'groupId': 'OG002'}]}]}, {'title': 'Hour 48 (N=19; 17; 8)', 'categories': [{'measurements': [{'value': '130.4', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '133.4', 'spread': '4.82', 'groupId': 'OG001'}, {'value': '127.6', 'spread': '2.36', 'groupId': 'OG002'}]}]}, {'title': 'Change from Baseline (N=19; 17; 8)', 'categories': [{'measurements': [{'value': '4.00', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '4.04', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '2.86', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'P-Values are not adjusted on the basis of multiple comparrisons', 'groupDescription': 'Statistical Analysis applies to "Change from Baseline".', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.019', 'groupIds': ['OG000', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-Values are not adjusted on the basis of multiple comparrisons', 'groupDescription': 'Statistical Analysis applies to "Change from Baseline".', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG001', 'OG002'], 'ciPctValue': '95', 'pValueComment': 'P-Values are not adjusted on the basis of multiple comparrisons', 'groupDescription': 'Statistical Analysis applies to "Change from Baseline".', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 48 hours', 'description': 'Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nHour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.\n\nChange is calculated as Hour 48 - Baseline.', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.\n\nThe number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'OG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'OG002', 'title': 'Regimen 3 Placebo'}], 'classes': [{'title': 'Baseline (N=20; 20; 9)', 'categories': [{'measurements': [{'value': '126.03', 'spread': '4.02', 'groupId': 'OG000'}, {'value': '126.39', 'spread': '3.58', 'groupId': 'OG001'}, {'value': '125.55', 'spread': '3.65', 'groupId': 'OG002'}]}]}, {'title': 'Hour 4 (N=19; 20; 8)', 'categories': [{'measurements': [{'value': '128.03', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '128.47', 'spread': '4.21', 'groupId': 'OG001'}, {'value': '125.80', 'spread': '4.63', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 4 (N=19; 20; 8)', 'categories': [{'measurements': [{'value': '1.59', 'spread': '2.32', 'groupId': 'OG000'}, {'value': '2.08', 'spread': '2.65', 'groupId': 'OG001'}, {'value': '-0.63', 'spread': '2.77', 'groupId': 'OG002'}]}]}, {'title': 'Hour 12 (N=19; 19; 7)', 'categories': [{'measurements': [{'value': '128.22', 'spread': '5.27', 'groupId': 'OG000'}, {'value': '130.85', 'spread': '5.88', 'groupId': 'OG001'}, {'value': '127.21', 'spread': '5.24', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 12 (N=19; 19; 7)', 'categories': [{'measurements': [{'value': '1.78', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '4.65', 'spread': '4.06', 'groupId': 'OG001'}, {'value': '0.73', 'spread': '3.92', 'groupId': 'OG002'}]}]}, {'title': 'Hour 16 (N=19; 17; 7)', 'categories': [{'measurements': [{'value': '129.34', 'spread': '4.51', 'groupId': 'OG000'}, {'value': '131.04', 'spread': '5.07', 'groupId': 'OG001'}, {'value': '127.57', 'spread': '3.78', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 16 (N=19; 17; 7)', 'categories': [{'measurements': [{'value': '2.90', 'spread': '3.46', 'groupId': 'OG000'}, {'value': '4.93', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '1.09', 'spread': '2.69', 'groupId': 'OG002'}]}]}, {'title': 'Hour 24 (N=18; 16; 8)', 'categories': [{'measurements': [{'value': '128.87', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '130.74', 'spread': '5.33', 'groupId': 'OG001'}, {'value': '127.48', 'spread': '3.62', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 24 (N=18; 16; 8)', 'categories': [{'measurements': [{'value': '2.66', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '4.62', 'spread': '3.59', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '2.73', 'groupId': 'OG002'}]}]}, {'title': 'Hour 28 (N=19; 17; 8)', 'categories': [{'measurements': [{'value': '130.79', 'spread': '4.94', 'groupId': 'OG000'}, {'value': '131.62', 'spread': '4.52', 'groupId': 'OG001'}, {'value': '126.49', 'spread': '4.03', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 28 (N=19; 17; 8)', 'categories': [{'measurements': [{'value': '4.35', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '5.51', 'spread': '2.75', 'groupId': 'OG001'}, {'value': '0.06', 'spread': '3.30', 'groupId': 'OG002'}]}]}, {'title': 'Hour 36 (N=19; 15; 8)', 'categories': [{'measurements': [{'value': '131.42', 'spread': '4.99', 'groupId': 'OG000'}, {'value': '132.47', 'spread': '5.04', 'groupId': 'OG001'}, {'value': '127.31', 'spread': '3.05', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 36 (N=19; 15; 8)', 'categories': [{'measurements': [{'value': '4.98', 'spread': '3.73', 'groupId': 'OG000'}, {'value': '6.54', 'spread': '3.28', 'groupId': 'OG001'}, {'value': '0.89', 'spread': '2.55', 'groupId': 'OG002'}]}]}, {'title': 'Hour 40 (N=19; 16; 8)', 'categories': [{'measurements': [{'value': '130.83', 'spread': '5.04', 'groupId': 'OG000'}, {'value': '132.23', 'spread': '3.99', 'groupId': 'OG001'}, {'value': '127.00', 'spread': '1.85', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 40 (N=19; 16; 8)', 'categories': [{'measurements': [{'value': '4.39', 'spread': '3.44', 'groupId': 'OG000'}, {'value': '6.30', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '0.58', 'spread': '1.66', 'groupId': 'OG002'}]}]}, {'title': 'Hour 48 (N=19; 17; 8)', 'categories': [{'measurements': [{'value': '130.44', 'spread': '5.21', 'groupId': 'OG000'}, {'value': '133.35', 'spread': '4.82', 'groupId': 'OG001'}, {'value': '127.59', 'spread': '2.36', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 48 (N=19; 17; 8)', 'categories': [{'measurements': [{'value': '4.00', 'spread': '3.80', 'groupId': 'OG000'}, {'value': '7.36', 'spread': '4.04', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '2.86', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48', 'description': 'Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nHour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.\n\nChange is calculated as Actual Data for each time point - Baseline', 'unitOfMeasure': 'mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.\n\nThe number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.'}, {'type': 'SECONDARY', 'title': 'Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}], 'classes': [{'categories': [{'measurements': [{'value': '16.43', 'groupId': 'OG000', 'lowerLimit': '12.00', 'upperLimit': '32.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '48 Hours', 'description': 'Confirmed sodium levels refers to two consecutive increases from baseline in sodium of \\>4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nThe endpoint was not evaluable in the placebo arm (median and interquartile range cannot be estimated) or the conivaptan QD arm (interquartile range cannot be estimated) because too high a percentage of patients were censored for the event. Only the conivaptan BID arm will be reported.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'OG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'OG002', 'title': 'Regimen 3 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 Hours', 'description': 'Confirmed sodium levels refers to two consecutive increases from baseline in sodium of \\>4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'OG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'OG002', 'title': 'Regimen 3 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 Hours', 'description': 'Confirmed sodium levels refers to two consecutive increases from baseline in sodium of \\>6 mEq/L or two consecutive measurements \\>135 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.'}, {'type': 'SECONDARY', 'title': 'Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'OG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'OG002', 'title': 'Regimen 3 Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '142.72', 'spread': '132.94', 'groupId': 'OG000'}, {'value': '244.17', 'spread': '142.64', 'groupId': 'OG001'}, {'value': '23.21', 'spread': '91.49', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.079', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '48 Hours', 'description': 'Each individual subject\'s change from baseline serum sodium levels was used to calculate baseline adjusted area under the curve serum sodium levels for a duration of Time 0 to Time t in hours (labeled as AUC(Na)(0-t). The last available serum sodium level prior to dosing on Day 1 was used as baseline.\n\n"t"=48 Hours', 'unitOfMeasure': 'Hour * mEq/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'OG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'OG002', 'title': 'Regimen 3 Placebo'}], 'classes': [{'title': 'Baseline (N=16; 12; 6)', 'categories': [{'measurements': [{'value': '6.76', 'spread': '47.91', 'groupId': 'OG000'}, {'value': '39.86', 'spread': '245.23', 'groupId': 'OG001'}, {'value': '18.66', 'spread': '45.05', 'groupId': 'OG002'}]}]}, {'title': 'Hour 12 (N=14; 12; 5)', 'categories': [{'measurements': [{'value': '355.65', 'spread': '684.35', 'groupId': 'OG000'}, {'value': '405.21', 'spread': '744.88', 'groupId': 'OG001'}, {'value': '136.22', 'spread': '154.94', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 12 (N=12;12; 4)', 'categories': [{'measurements': [{'value': '301.52', 'spread': '671.78', 'groupId': 'OG000'}, {'value': '365.35', 'spread': '699.96', 'groupId': 'OG001'}, {'value': '135.44', 'spread': '123.36', 'groupId': 'OG002'}]}]}, {'title': 'Hour 24 (N=14; 12; 6)', 'categories': [{'measurements': [{'value': '-50.19', 'spread': '794.22', 'groupId': 'OG000'}, {'value': '-261.27', 'spread': '1009.24', 'groupId': 'OG001'}, {'value': '368.01', 'spread': '688.81', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 24 (N=13; 11; 5)', 'categories': [{'measurements': [{'value': '-70.61', 'spread': '796.01', 'groupId': 'OG000'}, {'value': '-391.76', 'spread': '1206.39', 'groupId': 'OG001'}, {'value': '383.73', 'spread': '723.33', 'groupId': 'OG002'}]}]}, {'title': 'Hour 36 (N=15; 11; 6)', 'categories': [{'measurements': [{'value': '36.85', 'spread': '905.18', 'groupId': 'OG000'}, {'value': '12.66', 'spread': '743.24', 'groupId': 'OG001'}, {'value': '726.96', 'spread': '1013.78', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 36 (N=12; 8; 5)', 'categories': [{'measurements': [{'value': '-91.07', 'spread': '912.66', 'groupId': 'OG000'}, {'value': '-89.12', 'spread': '805.36', 'groupId': 'OG001'}, {'value': '810.45', 'spread': '1079.89', 'groupId': 'OG002'}]}]}, {'title': 'Hour 48 (N=14; 11; 5)', 'categories': [{'measurements': [{'value': '-77.37', 'spread': '1169.30', 'groupId': 'OG000'}, {'value': '-179.37', 'spread': '852.58', 'groupId': 'OG001'}, {'value': '569.09', 'spread': '1392.07', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 48 (N=12; 10; 4)', 'categories': [{'measurements': [{'value': '80.23', 'spread': '1116.99', 'groupId': 'OG000'}, {'value': '-240.39', 'spread': '759.82', 'groupId': 'OG001'}, {'value': '690.98', 'spread': '2872.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Hour 12, Hour 24,Hour 36 and Hour 48', 'description': 'Effective water clearence (EWC) was calculated as EWC=V(1-(Una+Uk)/(Pna+Pk)), where V is urine volume, Una is the urine sodium concentration, Uk is the urine potassium concentration, Pna is the serum/plasma sodium concentration, an Pk is the serum /plasma potassium concentration.\n\nBaseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nHour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.\n\nChange is calculated as Actual Data for each time point - Baseline', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.\n\nThe number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'OG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'OG002', 'title': 'Regimen 3 Placebo'}], 'classes': [{'title': 'Baseline (N=14; 11; 6)', 'categories': [{'measurements': [{'value': '-53.87', 'spread': '45.47', 'groupId': 'OG000'}, {'value': '6.55', 'spread': '165.07', 'groupId': 'OG001'}, {'value': '-34.90', 'spread': '74.32', 'groupId': 'OG002'}]}]}, {'title': 'Hour 24 (N=14; 12; 6)', 'categories': [{'measurements': [{'value': '-972.29', 'spread': '1455.66', 'groupId': 'OG000'}, {'value': '-611.14', 'spread': '693.863', 'groupId': 'OG001'}, {'value': '-416.71', 'spread': '666.97', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 24 (N=11; 10; 5)', 'categories': [{'measurements': [{'value': '-936.99', 'spread': '1618.46', 'groupId': 'OG000'}, {'value': '-513.33', 'spread': '566.72', 'groupId': 'OG001'}, {'value': '-420.75', 'spread': '747.84', 'groupId': 'OG002'}]}]}, {'title': 'Hour 48 (N=14;12; 5)', 'categories': [{'measurements': [{'value': '-1243.39', 'spread': '2211.22', 'groupId': 'OG000'}, {'value': '-769.19', 'spread': '934.31', 'groupId': 'OG001'}, {'value': '-592.96', 'spread': '1050.94', 'groupId': 'OG002'}]}]}, {'title': 'Change at Hour 48 (N=11; 10; 4)', 'categories': [{'measurements': [{'value': '-1313.98', 'spread': '2477.39', 'groupId': 'OG000'}, {'value': '-603.67', 'spread': '761.90', 'groupId': 'OG001'}, {'value': '-702.11', 'spread': '1117.92', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Hour 24 and Hour 48', 'description': 'Free water clearance (FWC) was calculated as FWC=V(1-Uosm/Posm), where V is urine volume, Uosm is the urine osmolality, Posm is the plasma sodium osmolality.\n\nBaseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nHour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.\n\nChange is calculated as Actual Data for each time point - Baseline', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all randomized patients who received at least one dose of study drug and who had baseline serum sodium data.\n\nThe number of participants analyzed per arm represents FAS. The numbers of participants for each visit are noted in the category titles.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'FG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'FG002', 'title': 'Regimen 3 Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'Full Analysis Set / Safety Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '9'}]}, {'type': 'End of Treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'One patient in the Placebo arm discontinued prior to dosing and therefore was not included in the Full Analysis Set (FAS) or the Safety Analysis Set (SAF).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day'}, {'id': 'BG001', 'title': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day'}, {'id': 'BG002', 'title': 'Regimen 3 Placebo'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.6', 'spread': '17.36', 'groupId': 'BG000'}, {'value': '67.5', 'spread': '14.70', 'groupId': 'BG001'}, {'value': '61.8', 'spread': '20.19', 'groupId': 'BG002'}, {'value': '62.8', 'spread': '17.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Population is Safety Analysis Set: All randomized patients who received at least one dose of study drug.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Population is Safety Analysis Set: All randomized patients who received at least one dose of study drug.', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Population is Safety Analysis Set: All randomized patients who received at least one dose of study drug.', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-30', 'studyFirstSubmitDate': '2007-05-22', 'resultsFirstSubmitDate': '2010-03-31', 'studyFirstSubmitQcDate': '2007-05-22', 'lastUpdatePostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-03-31', 'studyFirstPostDateStruct': {'date': '2007-05-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Sodium From Baseline to the 48 Hour Assessment or Study Drug Discontinuation.', 'timeFrame': 'Baseline and 48 hours', 'description': 'Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nHour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.\n\nChange is calculated as Hour 48 - Baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Serum Sodium Level at Each Time Point Through the 48 Hour Assessment', 'timeFrame': 'Baseline, Hour 4, Hour 12, Hour 16, Hour 24, Hour 28, Hour 36, Hour 40 and Hour 48', 'description': 'Baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nHour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.\n\nChange is calculated as Actual Data for each time point - Baseline'}, {'measure': 'Time From the First Dose of Study Medication to a Confirmed >4 mEq/L Increase From Baseline in Serum Sodium', 'timeFrame': '48 Hours', 'description': 'Confirmed sodium levels refers to two consecutive increases from baseline in sodium of \\>4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nThe endpoint was not evaluable in the placebo arm (median and interquartile range cannot be estimated) or the conivaptan QD arm (interquartile range cannot be estimated) because too high a percentage of patients were censored for the event. Only the conivaptan BID arm will be reported.'}, {'measure': 'Number of Patients With Confirmed Serum Sodium Level > 4 mEq/L Increase From Baseline Over 0 to 48 Hours', 'timeFrame': '48 Hours', 'description': 'Confirmed sodium levels refers to two consecutive increases from baseline in sodium of \\>4 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.'}, {'measure': 'Number of Patients With Confirmed Serum Sodium Level Increase >6 mEq/L From Baseline or Confirmed Normal Serum Sodium Level (>135 mEq/L) Over the Duration 0 to 48 Hours', 'timeFrame': '48 Hours', 'description': 'Confirmed sodium levels refers to two consecutive increases from baseline in sodium of \\>6 mEq/L or two consecutive measurements \\>135 mEq/L; baseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.'}, {'measure': 'Baseline -Adjusted Area Under the Curve (AUC) in Serum Sodium Over the Duration 0 to 48 Hours', 'timeFrame': '48 Hours', 'description': 'Each individual subject\'s change from baseline serum sodium levels was used to calculate baseline adjusted area under the curve serum sodium levels for a duration of Time 0 to Time t in hours (labeled as AUC(Na)(0-t). The last available serum sodium level prior to dosing on Day 1 was used as baseline.\n\n"t"=48 Hours'}, {'measure': 'Change From Baseline in Effective Water Clearance (EWC) at Each Time Point Through the 48-hour Assessment', 'timeFrame': 'Baseline, Hour 12, Hour 24,Hour 36 and Hour 48', 'description': 'Effective water clearence (EWC) was calculated as EWC=V(1-(Una+Uk)/(Pna+Pk)), where V is urine volume, Una is the urine sodium concentration, Uk is the urine potassium concentration, Pna is the serum/plasma sodium concentration, an Pk is the serum /plasma potassium concentration.\n\nBaseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nHour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.\n\nChange is calculated as Actual Data for each time point - Baseline'}, {'measure': 'Change From Baseline in Free Water Clearance (FWC) at Each Time Point Through the 48-hour Assessment', 'timeFrame': 'Baseline, Hour 24 and Hour 48', 'description': 'Free water clearance (FWC) was calculated as FWC=V(1-Uosm/Posm), where V is urine volume, Uosm is the urine osmolality, Posm is the plasma sodium osmolality.\n\nBaseline is the average of the two most recent serum sodium levels prior to start of dosing on day 1.\n\nHour 48: Hour 48 or time that ended study participation prior to the hour 48 assessment.\n\nChange is calculated as Actual Data for each time point - Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hyponatremia', 'hypervolemic', 'euvolemic', 'edematous', 'conivaptan'], 'conditions': ['Hyponatremia']}, 'referencesModule': {'references': [{'pmid': '21515866', 'type': 'BACKGROUND', 'citation': 'Koren MJ, Hamad A, Klasen S, Abeyratne A, McNutt BE, Kalra S. Efficacy and safety of 30-minute infusions of conivaptan in euvolemic and hypervolemic hyponatremia. Am J Health Syst Pharm. 2011 May 1;68(9):818-27. doi: 10.2146/ajhp100260.'}], 'seeAlsoLinks': [{'url': 'http://www.astellas.us/docs/vaprisol.pdf', 'label': 'Link to Prescribing Information'}]}, 'descriptionModule': {'briefSummary': 'The study is designed to assess the efficacy and safety of multiple infusions of conivaptan in subjects with euvolemic or hypervolemic hyponatremia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Euvolemic or hypervolemic (edematous) based on clinical presentation\n* Serum sodium between 115 and 130mEq/L at baseline\n\nExclusion Criteria:\n\n* Clinical presentation of volume depletion or dehydration'}, 'identificationModule': {'nctId': 'NCT00478192', 'briefTitle': 'Study of Efficacy & Safety for 3 Infusion Regimens of IV Conivaptan in Subjects With Euvolemic or Hypervolemic Hyponatremia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cumberland Pharmaceuticals'}, 'officialTitle': 'A Phase IIIb, Randomized, Double-Blind, Parallel Group, Multi-Center, Study to Assess the Efficacy and Safety of Multiple 30 Minute Infusions of YM087 (Conivaptan) in Subjects With Euvolemic or Hypervolemic Hyponatremia', 'orgStudyIdInfo': {'id': '087-CL-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regimen 1 Conivaptan QD', 'description': '20 mg conivaptan once a day', 'interventionNames': ['Drug: Conivaptan']}, {'type': 'EXPERIMENTAL', 'label': 'Regimen 2 Conivaptan BID', 'description': '20 mg conivaptan two times a day', 'interventionNames': ['Drug: Conivaptan']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Regimen 3 Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Conivaptan', 'type': 'DRUG', 'otherNames': ['YM087', 'Vaprisol'], 'description': 'premix bag', 'armGroupLabels': ['Regimen 1 Conivaptan QD', 'Regimen 2 Conivaptan BID']}, {'name': 'Placebo', 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