Viewing Study NCT00343460

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Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

Ignite Creation Date: 2025-12-25 @ 2:04 AM

Ignite Modification Date: 2025-12-26 @ 12:29 AM

Study NCT ID: NCT00343460

Status: COMPLETED

Last Update Posted: 2017-02-23

First Post: 2006-06-22

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017829', 'term': 'Granisetron'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D000077924', 'term': 'Palonosetron'}], 'ancestors': [{'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007191', 'term': 'Indazoles'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-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': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D007546', 'term': 'Isoquinolines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rgeller@herontx.com', 'phone': '650-366-2626', 'title': 'Robert Geller, M.D.', 'organization': 'Heron Therapeutics'}, 'certainAgreement': {'otherDetails': "A period of 60 working days for presentational material and abstracts and 90 days for manuscripts is permitted for the sponsor's review. The sponsor can request modifications of any manuscript or other materials to be published or presented. The sponsor can also request additional time to obtain additional patent protection or take such other measures to establish and preserve its intellectual property and proprietary rights before publishing information from this trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Cycle 1 APF530 5 mg', 'description': 'Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population', 'otherNumAtRisk': 464, 'otherNumAffected': 335, 'seriousNumAtRisk': 464, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Cycle 1 APF530 10 mg', 'description': 'Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population', 'otherNumAtRisk': 468, 'otherNumAffected': 349, 'seriousNumAtRisk': 468, 'seriousNumAffected': 36}, {'id': 'EG002', 'title': 'Cycle 1 Aloxi 0.25 mg', 'description': 'Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population', 'otherNumAtRisk': 472, 'otherNumAffected': 313, 'seriousNumAtRisk': 472, 'seriousNumAffected': 27}, {'id': 'EG003', 'title': 'Cycles 2-4 APF530 5 mg', 'description': 'Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population', 'otherNumAtRisk': 528, 'otherNumAffected': 422, 'seriousNumAtRisk': 528, 'seriousNumAffected': 61}, {'id': 'EG004', 'title': 'Cycle 2-4 APF530 10 mg', 'description': 'Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population', 'otherNumAtRisk': 515, 'otherNumAffected': 413, 'seriousNumAtRisk': 515, 'seriousNumAffected': 73}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 86}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 87}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 46}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 42}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 36}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 72}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 62}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 78}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 79}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 51}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 69}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 66}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 73}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 52}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 80}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 94}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 93}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 124}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 153}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 58}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 61}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site nodule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 57}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 90}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 34}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 32}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 29}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 29}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 21}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 21}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 29}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 47}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 38}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 44}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 27}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 23}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 31}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 34}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 35}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 19}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 82}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 69}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 3}, 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'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 515, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (9.0)'}, {'term': 'Septic phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 464, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 468, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 472, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 528, 'numAffected': 1}, {'groupId': 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'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cycle 1 - Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}, {'value': '240', 'groupId': 'OG004'}, {'value': '238', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 APF530 5 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG001', 'title': 'Cycle 1 APF530 10 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG002', 'title': 'Cycle 1 Aloxi 0.25 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG003', 'title': 'Cycle 1 APF530 5 mg - Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}, {'id': 'OG004', 'title': 'Cycle 1 APF530 10 mg - Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}, {'id': 'OG005', 'title': 'Cycle 1 Aloxi 0.25 Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}], 'classes': [{'title': 'CC during acute Phase', 'categories': [{'measurements': [{'value': '154', 'groupId': 'OG000'}, {'value': '152', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}, {'value': '183', 'groupId': 'OG004'}, {'value': '184', 'groupId': 'OG005'}]}]}, {'title': 'CC during the delayed-onset phase', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '138', 'groupId': 'OG003'}, {'value': '150', 'groupId': 'OG004'}, {'value': '147', 'groupId': 'OG005'}]}]}, {'title': 'CC during the overall risk period', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '127', 'groupId': 'OG003'}, {'value': '138', 'groupId': 'OG004'}, {'value': '136', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-120 Hours', 'description': 'Complete control is defined as complete response with no more than mild nausea.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cycle 1 - Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}, {'value': '240', 'groupId': 'OG004'}, {'value': '238', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 APF530 5 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG001', 'title': 'Cycle 1 APF530 10 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG002', 'title': 'Cycle 1 Aloxi 0.25 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG003', 'title': 'Cycle 1 APF530 5 mg - Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}, {'id': 'OG004', 'title': 'Cycle 1 APF530 10 mg - Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}, {'id': 'OG005', 'title': 'Cycle 1 Aloxi 0.25 Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}], 'classes': [{'title': 'TR during acute phase', 'categories': [{'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}, {'value': '141', 'groupId': 'OG003'}, {'value': '146', 'groupId': 'OG004'}, {'value': '158', 'groupId': 'OG005'}]}]}, {'title': 'TR during the delayed-onset phase', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '115', 'groupId': 'OG003'}, {'value': '113', 'groupId': 'OG004'}, {'value': '122', 'groupId': 'OG005'}]}]}, {'title': 'TR during the overall risk period', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '103', 'groupId': 'OG003'}, {'value': '101', 'groupId': 'OG004'}, {'value': '117', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-120 Hours', 'description': 'TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1.\n\nTR during delayed-onset phase is defined as Complete Response with no nausea during \\>24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cycle 1 - Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Number of Emetic Episodes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '208', 'groupId': 'OG000'}, {'value': '208', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '217', 'groupId': 'OG003'}, {'value': '236', 'groupId': 'OG004'}, {'value': '222', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 APF530 5 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG001', 'title': 'Cycle 1 APF530 10 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG002', 'title': 'Cycle 1 Aloxi 0.25 mg - 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Modified Intent-to-Treat Population (All Languages Except Punjabi)'}, {'type': 'SECONDARY', 'title': "Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '208', 'groupId': 'OG002'}, {'value': '229', 'groupId': 'OG003'}, {'value': '240', 'groupId': 'OG004'}, {'value': '238', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cycle 1 APF530 5 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG001', 'title': 'Cycle 1 APF530 10 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG002', 'title': 'Cycle 1 Aloxi 0.25 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'OG003', 'title': 'Cycle 1 APF530 5 mg - 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Safety Population'}, {'id': 'FG001', 'title': 'APF530 10 mg', 'description': 'APF530 10 mg - Safety Population'}, {'id': 'FG002', 'title': 'Aloxi 0.25 mg', 'description': 'Aloxi 0.25 mg - Safety Population'}], 'periods': [{'title': 'Cycle 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '475'}, {'groupId': 'FG001', 'numSubjects': '481'}, {'groupId': 'FG002', 'numSubjects': '472'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '453'}, {'groupId': 'FG001', 'numSubjects': '459'}, {'groupId': 'FG002', 'numSubjects': '454'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '18'}]}]}, {'title': 'Cycle 2 - 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '584'}, {'groupId': 'FG001', 'numSubjects': '565'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '528'}, {'groupId': 'FG001', 'numSubjects': '515'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '50'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '208', 'groupId': 'BG002'}, {'value': '229', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}, {'value': '238', 'groupId': 'BG005'}, {'value': '1341', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cycle 1 APF530 5 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'BG001', 'title': 'Cycle 1 APF530 10 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'BG002', 'title': 'Cycle 1 Aloxi 0.25 mg - Moderately', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Moderately'}, {'id': 'BG003', 'title': 'Cycle 1 APF530 5 mg - Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}, {'id': 'BG004', 'title': 'Cycle 1 APF530 10 mg - Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}, {'id': 'BG005', 'title': 'Cycle 1 Aloxi 0.25 Highly', 'description': 'Cycle 1 - Modified Intent-to-Treat Population\n\nEmetogenic Status: Highly'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'spread': '12.80', 'groupId': 'BG000'}, {'value': '55.1', 'spread': '12.79', 'groupId': 'BG001'}, {'value': '57.3', 'spread': '12.36', 'groupId': 'BG002'}, {'value': '57.6', 'spread': '13.35', 'groupId': 'BG003'}, {'value': '56.8', 'spread': '13.20', 'groupId': 'BG004'}, {'value': '58.1', 'spread': '13.74', 'groupId': 'BG005'}, {'value': '56.62', 'spread': '13.04', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '177', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}, {'value': '153', 'groupId': 'BG003'}, {'value': '152', 'groupId': 'BG004'}, {'value': '158', 'groupId': 'BG005'}, {'value': '1006', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '88', 'groupId': 'BG004'}, {'value': '80', 'groupId': 'BG005'}, {'value': '335', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Modified Intent-to-Treat Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1428}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-10', 'studyFirstSubmitDate': '2006-06-22', 'resultsFirstSubmitDate': '2016-09-09', 'studyFirstSubmitQcDate': '2006-06-22', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-10-31', 'studyFirstPostDateStruct': {'date': '2006-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Patients With Complete Response (CR) During Acute Phase (0-24 Hours) After Administration of Chemotherapy Course 1', 'timeFrame': '0-24 Hours', 'description': 'Complete Response is defined as no emetic episodes and no use of rescue medications'}, {'measure': 'Proportion of Patients With CR During Delayed-onset Phase (24-120 Hours) After Administration of Chemotherapy Course 1', 'timeFrame': '24-120 Hours', 'description': 'Complete Response is defined as no emetic episodes and no use of rescue medications'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients With Complete Control During the Acute Phase (0-24 Hours), Delayed-onset Phase (24-120 Hours), and During Chemotherapy Course 1', 'timeFrame': '0-120 Hours', 'description': 'Complete control is defined as complete response with no more than mild nausea.'}, {'measure': 'Proportion of Patients With Total Response During the Acute Phase, Delayed-onset Phase, and During Chemotherapy Course 1', 'timeFrame': '0-120 Hours', 'description': 'TR during acute phase is defined as Complete Response with no nausea during 0 to 24 hours following the administration of chemotherapy in Cycle 1.\n\nTR during delayed-onset phase is defined as Complete Response with no nausea during \\>24 to 120 hours following the administration of chemotherapy in Cycle 1. TR during overall risk period is defined as Complete Response with no nausea during 0 to 120 hours following the administration of chemotherapy in Cycle 1.'}, {'measure': 'Number of Emetic Episodes', 'timeFrame': 'Days 1-5', 'description': 'Number of Emetic Episodes - days 1-5'}, {'measure': 'Time to First Treatment Failure', 'timeFrame': '0-120 Hours', 'description': 'Proportions of subjects event free at 24, 48, 72, 96, and 120 hours after chemotherapy administration'}, {'measure': 'First and Overall Use of Rescue Medication', 'timeFrame': '0-120 Hours'}, {'measure': 'Severity of Nausea Daily and During Chemotherapy Course 1 (0-120 Hours)', 'timeFrame': '0-120 Hours', 'description': 'Maximum severity of nausea, days 1-5'}, {'measure': 'Sustainability of Antiemetic Effect of APF530 Over Multiple Chemotherapy Courses', 'timeFrame': '0-120 Hours', 'description': 'Sustainability of Overall Complete Response (CR 0-120 hrs) Over Two, Three, and Four Cycles\n\nComplete Response is defined as no emetic episodes and no use of rescue medications'}, {'measure': 'Quality of Life and the Impact of Nausea and Vomiting on Day 5', 'timeFrame': '5 days', 'description': 'Functional Living Index'}, {'measure': "Patient's Global Satisfaction With Antiemetic Therapy During Acute Phase and Chemotherapy Course 1", 'timeFrame': '0- 24 Hours', 'description': 'Subject who were very satisfied on Day 1'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nausea and vomiting', 'unspecified adult solid tumor, protocol specific'], 'conditions': ['Nausea and Vomiting', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '26921245', 'type': 'DERIVED', 'citation': "Boccia R, O'Boyle E, Cooper W. Randomized phase III trial of APF530 versus palonosetron in the prevention of chemotherapy-induced nausea and vomiting in a subset of patients with breast cancer receiving moderately or highly emetogenic chemotherapy. BMC Cancer. 2016 Feb 26;16:166. doi: 10.1186/s12885-016-2186-4."}, {'pmid': '26289588', 'type': 'DERIVED', 'citation': "Raftopoulos H, Boccia R, Cooper W, O'Boyle E, Gralla RJ. Slow-release granisetron (APF530) versus palonosetron for chemotherapy-induced nausea/vomiting: analysis by American Society of Clinical Oncology emetogenicity criteria. Future Oncol. 2015 Sep;11(18):2541-51. doi: 10.2217/fon.15.185. Epub 2015 Aug 20."}]}, 'descriptionModule': {'briefSummary': 'This randomized phase III trial is studying APF530 and dexamethasone to see how well they work compared with palonosetron and dexamethasone in preventing nausea and vomiting in patients receiving chemotherapy for cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the overall activity and effects of APF530 versus palonosetron hydrochloride in combination with dexamethasone for prophylaxis of acute- or delayed-onset, chemotherapy-induced nausea and vomiting in patients undergoing moderately or highly emetogenic chemotherapy for cancer.\n\nSecondary\n\n* Evaluate the safety, tolerability, and efficacy of APF530, in terms of prevention of acute- and delayed-onset nausea and vomiting, in these patients.\n* Gather the pharmacokinetics of APF530 in a subset of patients during chemotherapy course 1.\n* Gather ECG data (using 24-hour Holter monitoring) in a subset of patients during chemotherapy course 1.\n\nOUTLINE: This is a randomized, placebo-controlled, double-blind, parallel-group, multicenter study. Patients are stratified according to emetogenicity of scheduled chemotherapy (moderate-risk \\[level 3 or 4\\] vs high-risk \\[level 5\\]). Patients are randomized to 1 of 3 treatment arms (I, II, and III). Patients who are randomized to receive palonosetron hydrochloride during chemotherapy course 1 (arm I) are then re-randomized to 1 of 2 treatment arms (II and III) after chemotherapy course 1 to receive treatment during chemotherapy courses 2-4.\n\nPatients receive palonosetron hydrochloride or APF530 and/or placebo 30-60 minutes before the start of chemotherapy. Patients receive dexamethasone 30-90 minutes before the start of chemotherapy.\n\n* Arm I: Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses.\n* Arm II: Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.\n* Arm III: Patients receive APF530 SC at a higher dose, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher dose) and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.\n\nA subset of patients undergo blood collection periodically during study for analysis of plasma APF530 concentration.\n\nQuality of life is assessed on day 5 after completion of chemotherapy course 1.\n\nAfter completion of study treatment, patients are followed at approximately 30 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed malignant disease\n\n * No head and neck cancer or upper gastrointestinal cancer\n* Scheduled to receive a single day of moderately or highly emetogenic chemotherapy regimen (for ≤ 4 courses)\n\n * Chemotherapy administration ≤ 4 hours\n * Duration of each course ≤ 28 days\n * Causing nausea and vomiting in 30-100% of patients if untreated according to Hesketh algorithm\n* Must be able to receive standardized doses of dexamethasone for the prevention of emesis during study treatment\n* No greater than mild nausea or any vomiting within 24 hours before beginning study treatment\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No known allergy or hypersensitivity to other selective 5-HT3 receptor antagonists or local anesthetics\n* QTc interval ≤ 500 ms\n* No cardiac abnormality predisposing the patient to arrhythmia\n* No psychological problem that, in the opinion of the investigator, is severe enough to preclude study participation\n* No recent history (i.e., ≤ 1 year) of alcohol or drug abuse\n* No concurrent condition that, in the opinion of the investigator, could affect assessment of study medication or interfere with the nausea/vomiting response (e.g., severe renal or hepatic impairment)\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* No radiotherapy 7 days prior to, during, and 5 days after completion of study treatment\n* More than 7 days since prior chemotherapy\n* More than 7 days since prior and no concurrent prohibited medications (e.g., CYP3A4 inhibitors or other antiemetic medications)\n* More than 7 days since prior antinausea medications\n* More than 30 days since prior treatment on an investigational trial\n* No other concurrent corticosteroids or dexamethasone at a different dose than study treatment\n* No concurrent use of APF530, palonosetron hydrochloride, or aprepitant as rescue medications'}, 'identificationModule': {'nctId': 'NCT00343460', 'briefTitle': 'APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Heron Therapeutics'}, 'officialTitle': 'A Pivotal Phase 3 Observer-Blind, Randomized Clinical Trial of the Efficacy and Safety of APF530 Compared to Aloxi For The Prevention of Acute-Onset and Delayed-Onset Chemotherapy-Induced Nausea and Vomiting Following The Administration of Either Moderately or Highly Emetogenic Chemotherapy Regimens', 'orgStudyIdInfo': {'id': 'C2006-01'}, 'secondaryIdInfos': [{'id': 'APPA-C2006-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I', 'description': 'Patients receive palonosetron hydrochloride IV, placebo subcutaneously (SC), and dexamethasone IV on day 1 of chemotherapy course 1. Patients in the high-risk (level 5) stratum also receive oral dexamethasone on days 2-4 of all treatment courses.', 'interventionNames': ['Drug: dexamethasone', 'Drug: Palonosetron Hydrochloride', 'Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II', 'description': 'Patients receive APF530 SC, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.', 'interventionNames': ['Drug: APF530', 'Drug: dexamethasone', 'Other: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III', 'description': 'Patients receive APF530 SC at a higher dose, placebo IV, and dexamethasone IV on day 1 of chemotherapy course 1. Patients then receive APF530 SC (at the same higher dose) and dexamethasone IV on day 1 of chemotherapy courses 2-4. Patients in the high-risk (level 5) stratum also receive oral dexamethasone as in arm I.', 'interventionNames': ['Drug: APF530', 'Drug: dexamethasone', 'Other: placebo']}], 'interventions': [{'name': 'APF530', 'type': 'DRUG', 'description': 'Given subcutanously', 'armGroupLabels': ['Arm II', 'Arm III']}, {'name': 'dexamethasone', 'type': 'DRUG', 'description': 'Given IV and orally', 'armGroupLabels': ['Arm I', 'Arm II', 'Arm III']}, {'name': 'Palonosetron Hydrochloride', 'type': 'DRUG', 'description': 'Given IV', 'armGroupLabels': ['Arm I']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Given subcutanously or IV', 'armGroupLabels': ['Arm I', 'Arm II', 'Arm III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Anniston Oncology, PC', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '85304', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Palo Verde Hematology Oncology - 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