Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-19 @ 4:47 PM
Study NCT ID:
NCT04503668
Status:
TERMINATED
Last Update Posted:
2025-06-18
First Post:
2020-08-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D064729', 'term': 'Neurokinin-1 Receptor Antagonists'}, {'id': 'C579707', 'term': 'fosaprepitant'}, {'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D011346', 'term': 'Prochlorperazine'}], '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'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D010640', 'term': 'Phenothiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsgov_CCAdmin@umich.edu', 'phone': '734-936-9499', 'title': 'University of Michigan Rogel Cancer Center ClinicalTrials.gov Admin', 'organization': 'University of Michigan Rogel Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse event data (serious and non-serious) collected from the time of the initial study treatment administration through 30 days after the last dose of study treatment. Up to 2 years. Adverse Events will be evaluated with secondary endpoints', 'description': 'Adverse Events and All-Cause Mortality will be evaluated with secondary endpoints', 'eventGroups': [{'id': 'EG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 24, 'seriousNumAtRisk': 27, 'deathsNumAffected': 4, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 23, 'seriousNumAtRisk': 24, 'deathsNumAffected': 6, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'abdominal cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'abdominal distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 18, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'bloating', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'cognitive disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'facial flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 27, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 19, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 9, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'white blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}, {'term': 'debulking surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE version 5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 hours post initiating chemotherapy during cycle 1', 'description': 'Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours post initiating chemotherapy during cycle 1', 'description': 'Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24-120 hours post initiating chemotherapy during cycle 1', 'description': 'Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours post initiating chemotherapy during cycle 1', 'description': 'Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 hours post initiating chemotherapy during cycle 1', 'description': 'Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '120 hours post initiating chemotherapy during cycle 1', 'description': 'Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Somnolence Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '0.81', 'groupId': 'OG000', 'lowerLimit': '0.13', 'upperLimit': '1.49'}, {'value': '1.15', 'groupId': 'OG001', 'lowerLimit': '0.39', 'upperLimit': '1.93'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessed daily, and reported at day 6 post final study treatment', 'description': 'Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Increased-appetite Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'OG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'groupId': 'OG000', 'lowerLimit': '0.06', 'upperLimit': '0.85'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.56'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'assessed daily, and reported at day 6 post final study treatment', 'description': 'Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'FG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Incomplete data', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nNeurokinin-1 Receptor Antagonist (NK1-RA): 150 mg IV on day 1 pre-chemotherapy\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'BG001', 'title': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.\n\nOndansetron: 8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy\n\nDexamethasone: 20 mg IV on day 1 pre-chemotherapy\n\nOlanzapine: 5 mg by mouth on days 1-4 of chemotherapy (taken at night)\n\nCompazine: 5-10 mg by mouth, available as needed, every 6 hours, days 1-5'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000', 'lowerLimit': '64', 'upperLimit': '73'}, {'value': '72', 'groupId': 'BG001', 'lowerLimit': '61', 'upperLimit': '74'}, {'value': '69', 'groupId': 'BG002', 'lowerLimit': '61', 'upperLimit': '74'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-04', 'size': 599373, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-04-02T16:34', 'hasProtocol': True}, {'date': '2023-05-18', 'size': 762781, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-02T16:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'whyStopped': 'Lack of Patient Population', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'dispFirstSubmitDate': '2024-12-28', 'completionDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2020-08-03', 'resultsFirstSubmitDate': '2025-04-03', 'studyFirstSubmitQcDate': '2020-08-03', 'dispFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-04', 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Complete Response in the Overall Time Period (0 - 120 Hours Post-chemotherapy)', 'timeFrame': '120 hours post initiating chemotherapy during cycle 1', 'description': 'Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.'}], 'secondaryOutcomes': [{'measure': 'Rate of Complete Response in the Acute Time Period (0 - 24 Hours Post-chemotherapy)', 'timeFrame': '24 hours post initiating chemotherapy during cycle 1', 'description': 'Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.'}, {'measure': 'Rate of Complete Response in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)', 'timeFrame': '24-120 hours post initiating chemotherapy during cycle 1', 'description': 'Complete response (CR) is defined as no episodes of vomiting and no use of rescue antiemetic medications. Patient reported diaries will be used to measure this outcome.'}, {'measure': 'Rate of no Nausea in the Acute Time Period (0 - 24 Hours Post-chemotherapy)', 'timeFrame': '24 hours post initiating chemotherapy during cycle 1', 'description': 'Patients will record daily levels of nausea after chemotherapy using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).'}, {'measure': 'Rate of no Nausea in the Delayed Time Period (24 - 120 Hours Post-chemotherapy)', 'timeFrame': '120 hours post initiating chemotherapy during cycle 1', 'description': 'Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).'}, {'measure': 'Rate of no Nausea in the Overall Time Period (0 - 120 Hours Post-chemotherapy)', 'timeFrame': '120 hours post initiating chemotherapy during cycle 1', 'description': 'Patients will record daily levels of nausea using a Likert scale ranging from 0-10 (0 indicating no nausea; 10 indicating maximum level of nausea).'}, {'measure': 'Mean Somnolence Score', 'timeFrame': 'assessed daily, and reported at day 6 post final study treatment', 'description': 'Patients will record daily levels of undesired sedation using a Likert scale ranging from 0 to 10 (0 indicating no undesired sedation; 10 indicating maximum level of undesired sedation).'}, {'measure': 'Mean Increased-appetite Score', 'timeFrame': 'assessed daily, and reported at day 6 post final study treatment', 'description': 'Patients will record daily levels of undesired increase in appetite using a Likert scale ranging from 0 to 10 (0 indicating no undesired increase in appetite; 10 indicating maximum level of undesired increase in appetite).'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Cancer']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the efficacy of olanzapine as compared to neurokinin-1 receptor antagonists (NK1-RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients with gynecologic malignancies receiving single day outpatient chemotherapy (carboplatin and paclitaxel) every 3 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of gynecologic malignancy\n* No chemotherapy in the last 12 months\n* Scheduled to receive Carboplatin (AUC\\>=4) and Paclitaxel every three weeks\n* ECOG performance status 0 or 1\n* English speaking\n* Willing and able to provide informed consent\n* Laboratory values within protocol-defined parameters\n* No vomiting in the 24 hours prior to initiating chemotherapy\n* If childbearing potential exists, negative pregnancy test within 7 days prior to registration\n\nExclusion Criteria:\n\n* Significant cognitive compromise\n* History of CNS disease (e.g. brain metastases, seizure disorder, dementia)\n* Current or recent (within 30 days) treatment with another antipsychotic agent (antidepressant medications are OK)\n* Concurrent radiotherapy treatment\n* Known hypersensitivity to olanzapine\n* Known cardiac arrhythmia, uncontrolled congestive heart failure or acute myocardial infarction within the last six months\n* History of diabetes mellitus on medication (insulin or oral glycemic agent)\n* Alcohol abuse / chronic alcoholism\n* History of closed angle glaucoma\n* Current enrollment in other clinical trials'}, 'identificationModule': {'nctId': 'NCT04503668', 'briefTitle': 'Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Gynecologic Oncology Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan Rogel Cancer Center'}, 'officialTitle': 'Phase III Randomized Control Trial Investigating Olanzapine for the Prevention of Chemotherapy Induced Nausea and Vomiting in Patients With Gynecologic Malignancies Receiving Every 3-week Carboplatin and Paclitaxel Chemotherapy', 'orgStudyIdInfo': {'id': 'UMCC 2019.173'}, 'secondaryIdInfos': [{'id': 'HUM00175458', 'type': 'OTHER', 'domain': 'University of Michigan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nk1-RA', 'description': 'Nk1-RA will be given on day 1 of each 3-week chemotherapy cycle, for up to 6 cycles.', 'interventionNames': ['Drug: Ondansetron', 'Drug: Dexamethasone', 'Drug: Neurokinin-1 Receptor Antagonist (NK1-RA)', 'Drug: Compazine']}, {'type': 'EXPERIMENTAL', 'label': 'Olanzapine', 'description': 'Olanzapine will be given on days 1-4 of each 3-week chemotherapy cycle, for up to 6 cycles.', 'interventionNames': ['Drug: Ondansetron', 'Drug: Dexamethasone', 'Drug: Olanzapine', 'Drug: Compazine']}], 'interventions': [{'name': 'Ondansetron', 'type': 'DRUG', 'description': '8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy', 'armGroupLabels': ['Nk1-RA', 'Olanzapine']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': '20 mg IV on day 1 pre-chemotherapy', 'armGroupLabels': ['Nk1-RA', 'Olanzapine']}, {'name': 'Neurokinin-1 Receptor Antagonist (NK1-RA)', 'type': 'DRUG', 'otherNames': ['Fosaprepitant'], 'description': '150 mg IV on day 1 pre-chemotherapy', 'armGroupLabels': ['Nk1-RA']}, {'name': 'Olanzapine', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': '5 mg by mouth on days 1-4 of chemotherapy (taken at night)', 'armGroupLabels': ['Olanzapine']}, {'name': 'Compazine', 'type': 'DRUG', 'description': '5-10 mg by mouth, available as needed, every 6 hours, days 1-5', 'armGroupLabels': ['Nk1-RA', 'Olanzapine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Rogel Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Aimee Rolston', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan Rogel Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan Rogel Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}