Viewing Study NCT01857232

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Ignite Creation Date: 2025-12-24 @ 9:45 PM
Ignite Modification Date: 2025-12-31 @ 9:13 AM
Study NCT ID: NCT01857232
Status: COMPLETED
Last Update Posted: 2020-11-25
First Post: 2013-05-16
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy
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': 'D017294', 'term': 'Ondansetron'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C579707', 'term': 'fosaprepitant'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GabrielFox@acaciapharma.com', 'phone': '+44-(0)1223-875149', 'title': 'Dr Gabriel Fox', 'phoneExt': '149', 'organization': 'Acacia Pharma Ltd'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There were no limitations and caveats with this study'}}, 'adverseEventsModule': {'timeFrame': '7 Days', 'eventGroups': [{'id': 'EG000', 'title': 'Control', 'description': 'ACUTE (day 1): IV OND + FOS + DEX\n\n• DELAYED (days 2 to 4): Oral DEX', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 36, 'seriousNumAtRisk': 66, 'deathsNumAffected': 2, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Placebo', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 47, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'APD403 10MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 10 mg', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 34, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'APD403 20MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 20 mg', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 21, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'ADP403 40MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 40 mg', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 28, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Mucosal Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Electrocardiogram QT Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood Creatine Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nervousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Duodenal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Blood Prolactin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'General Physical Condition Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 65, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Delayed Phase Complete Response(CR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ACUTE (day 1): IV OND + FOS + DEX\n\n• DELAYED (days 2 to 4): Oral DEX'}, {'id': 'OG001', 'title': 'PLACEBO', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral Placebo'}, {'id': 'OG002', 'title': 'APD403 10MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 10 mg'}, {'id': 'OG003', 'title': 'ADP421 20MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 20 mg'}, {'id': 'OG004', 'title': 'APD421 40MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 40 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.004', 'groupIds': ['OG001', 'OG002'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0987', 'groupIds': ['OG001', 'OG003'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1041', 'groupIds': ['OG001', 'OG004'], 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-120 hours', 'description': 'Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy.\n\nThe primary endpoint was analysed separately in the strata of chemotherapy regimen and gender, and in the strata of country.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Number of Participants With CR in the Overall Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '68', 'groupId': 'OG003'}, {'value': '65', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Control', 'description': 'ACUTE (day 1): IV OND + FOS + DEX\n\n• DELAYED (days 2 to 4): Oral DEX'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo'}, {'id': 'OG002', 'title': 'APD403 10MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 10 mg'}, {'id': 'OG003', 'title': 'APD403 20MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 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'timeFrame': '0 to 120 hours after the initiation of chemotherapy', 'description': 'CR defined as no emesis and no use of rescue medication, in the overall phase (0 to 120 hours after the initiation of chemotherapy)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control', 'description': 'ACUTE (day 1): IV OND + FOS + DEX\n\n• DELAYED (days 2 to 4): Oral DEX'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo'}, {'id': 'FG002', 'title': 'APD403 10MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 10 mg'}, {'id': 'FG003', 'title': 'APD403 20MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 20 mg'}, {'id': 'FG004', 'title': 'ADP403 40MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 40 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '67'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '70'}, {'groupId': 'FG004', 'numSubjects': '69'}]}, {'type': 'Evaluable ITT', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '68'}, {'groupId': 'FG004', 'numSubjects': '65'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '63'}, {'groupId': 'FG003', 'numSubjects': '68'}, {'groupId': 'FG004', 'numSubjects': '63'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '65', 'groupId': 'BG004'}, {'value': '328', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Control ( Dexamethazon)', 'description': 'ACUTE (day 1): IV OND + FOS + DEX\n\n• DELAYED (days 2 to 4): Oral DEX'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg DELAYED (days 2 to 4): Oral Placebo'}, {'id': 'BG002', 'title': 'APD403 10MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 10 mg'}, {'id': 'BG003', 'title': 'APD403 20MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 20 mg'}, {'id': 'BG004', 'title': 'ADP403 40MG', 'description': 'ACUTE (day 1): IV OND + APD403 20 mg\n\n• DELAYED (days 2 to 4): Oral APD403 40 mg'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '10.38', 'groupId': 'BG000'}, {'value': '57.3', 'spread': '11.01', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '11.24', 'groupId': 'BG002'}, {'value': '56.6', 'spread': '10.53', 'groupId': 'BG003'}, {'value': '56.5', 'spread': '10.59', 'groupId': 'BG004'}, {'value': '57.1', 'spread': '10.70', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '51', 'groupId': 'BG004'}, {'value': '257', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '71', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}, {'value': '68', 'groupId': 'BG003'}, {'value': '64', 'groupId': 'BG004'}, {'value': '323', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Denmark', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '108', 'groupId': 'BG005'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '147', 'groupId': 'BG005'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'dispFirstSubmitDate': '2016-07-28', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-11', 'studyFirstSubmitDate': '2013-05-16', 'dispFirstSubmitQcDate': '2016-07-28', 'resultsFirstSubmitDate': '2018-11-27', 'studyFirstSubmitQcDate': '2013-05-17', 'dispFirstPostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-20', 'studyFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Delayed Phase Complete Response(CR)', 'timeFrame': '24-120 hours', 'description': 'Delayed phase complete response (CR), defined as an absence of emetic episodes and no rescue medication use in the period from 24 to 120 hours after the initiation of chemotherapy.\n\nThe primary endpoint was analysed separately in the strata of chemotherapy regimen and gender, and in the strata of country.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With CR in the Overall Phase.', 'timeFrame': '0 to 120 hours after the initiation of chemotherapy', 'description': 'CR defined as no emesis and no use of rescue medication, in the overall phase (0 to 120 hours after the initiation of chemotherapy)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['CINV']}, 'referencesModule': {'references': [{'pmid': '30488222', 'type': 'DERIVED', 'citation': 'Herrstedt J, Summers Y, Jordan K, von Pawel J, Jakobsen AH, Ewertz M, Chan S, Naik JD, Karthaus M, Dubey S, Davis R, Fox GM. Amisulpride prevents nausea and vomiting associated with highly emetogenic chemotherapy: a randomised, double-blind, placebo-controlled, dose-ranging trial. Support Care Cancer. 2019 Jul;27(7):2699-2705. doi: 10.1007/s00520-018-4564-8. Epub 2018 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of efficacy of APD403 at preventing delayed sickness in patients who have received cancer chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria\n\n* Male or female patients ≥ 18 years of age\n* Ability and willingness to give written informed consent\n* Patients scheduled to receive, on day 1 of their chemotherapy, either: (i) a first cisplatin chemotherapy infusion at a dose of ≥70 mg/m2 (males and females); or (ii) a first infusion of cyclophosphamide at a dose of 500-1500 mg/m2 in combination with either epirubicin at a dose of 60-100 mg/m2 or doxorubicin at a dose of 40-60 mg/m2 (females only)\n* Karnofsky performance score ≥ 60%\n* Adequate cardiac, hepatic and renal function\n\n * QTc interval \\< 500 ms\n * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\< 5 x upper limit normal (ULN)\n * Bilirubin \\< 5 x ULN\n * Creatinine \\< 3 x ULN\n* Adequate haematological function\n\n * Haemoglobin ≥ 8 g/dL\n * White blood count ≥ 3.0 x 109/L\n * Platelet count ≥ 100 x 109/L\n* For females of child-bearing potential: ability and willingness to use a highly effective form of contraception (e.g., abstinence from sexual intercourse, surgical sterilisation (of subject or partner) or a double-barrier method of contraception such as either an intra-uterine device (IUD) or an occlusive cap with spermicide, in conjunction with partner's use of a condom) during the study and for a period of at least 48 hours afterwards\n\nExclusion Criteria\n\n* Patients scheduled to receive, prior to or in the 120 hours after cisplatin or AC, any other chemotherapeutic agent with a high or moderate emetic risk\n* Patients who have previously received anti-neoplastic chemotherapy\n* Patients scheduled to receive paclitaxel or docetaxel during the first cycle of their chemotherapy\n* Patients undergoing abdominal or pelvic irradiation within 48 hours prior to screening or scheduled to receive abdominal or pelvic irradiation between screening and 24 hours after cisplatin or AC administration\n* Patients with a known prolactin-dependent tumour (e.g. pituitary gland prolactinoma or confirmed prolactin-dependent breast cancer) or phaeochromocytoma\n* Patients with a pre-existing vestibular disorder\n* Patients being treated with regular anti-emetic therapy including corticosteroids\n* Patients receiving inhaled corticosteroids, unless started more than one month prior to the expected date of study entry"}, 'identificationModule': {'nctId': 'NCT01857232', 'briefTitle': 'Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Acacia Pharma Ltd'}, 'officialTitle': 'Randomised, Double-blind, Dose-finding Phase II Study to Assess the Efficacy of APD403 in the Prevention of Nausea and Vomiting Caused by Cisplatin- or Anthracycline/Cyclophosphamide (AC)-Based Chemotherapy', 'orgStudyIdInfo': {'id': 'DN10016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'OND + DEX + FOS followed by oral DEX', 'interventionNames': ['Drug: Ondansetron', 'Drug: Dexamethasone', 'Drug: Fosaprepitant']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'OND + APD403 followed by oral PLACEBO', 'interventionNames': ['Drug: Ondansetron', 'Drug: Placebo', 'Drug: APD403 IV']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose APD403', 'description': 'OND + APD403 followed by oral APD403 low dose', 'interventionNames': ['Drug: Ondansetron', 'Drug: APD403 IV', 'Drug: APD403 oral']}, {'type': 'EXPERIMENTAL', 'label': 'Mid dose APD403', 'description': 'OND + APD403 followed by oral APD403 mid dose', 'interventionNames': ['Drug: Ondansetron', 'Drug: APD403 IV', 'Drug: APD403 oral']}, {'type': 'EXPERIMENTAL', 'label': 'High dose APD403', 'description': 'OND + APD403 followed by oral APD403 high dose', 'interventionNames': ['Drug: Ondansetron', 'Drug: APD403 IV', 'Drug: APD403 oral']}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'description': '5HT3-antagonist', 'armGroupLabels': ['Control', 'High dose APD403', 'Low dose APD403', 'Mid dose APD403', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Comparator', 'armGroupLabels': ['Placebo']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Corticosteroid', 'armGroupLabels': ['Control']}, {'name': 'Fosaprepitant', 'type': 'DRUG', 'description': 'NK1 antagonist', 'armGroupLabels': ['Control']}, {'name': 'APD403 IV', 'type': 'DRUG', 'description': 'Amisulpride IV 20 mg', 'armGroupLabels': ['High dose APD403', 'Low dose APD403', 'Mid dose APD403', 'Placebo']}, {'name': 'APD403 oral', 'type': 'DRUG', 'description': 'Amisulpride oral 10, 20 or 40 mg', 'armGroupLabels': ['High dose APD403', 'Low dose APD403', 'Mid dose APD403']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Odense', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Jørn Herrstedt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acacia Pharma Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}