Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-30 @ 11:27 AM
Study NCT ID:
NCT01339260
Status:
COMPLETED
Last Update Posted:
2014-11-26
First Post:
2011-04-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'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': 'C000595957', 'term': 'netupitant, palosentron drug combination'}, {'id': 'D000077924', 'term': 'Palonosetron'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'marco.palmas@helsinn.com', 'phone': '+41 91 9852121', 'title': 'Head of Clinical Development', 'organization': 'Helsinn Healthcare SA'}, 'certainAgreement': {'otherDetails': "Sponsor and investigator(s) agree that no publications discussing trials' results will occur until release of final report. Sponsor has no objections if the investigators publish study results, however the investigator is requested to contact the sponsor before publishing, to prevent premature disclosure of data and is not intended as a restrictive measure concerning results or opinions of investigators.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Period from time of informed consent signature until 21 days post study drugs (Day 1 of the last cycle). Upon Investigator's judgment, all non resolved, non serious Adverse Events (AEs) beyond this date could have been followed for an additional 14 days", 'description': 'AEs are presented separately for cycle 1 and for multi-cycle extension (i.e. without Cycle 1), consistent with Analysis Plan and Clinical Study Report', 'eventGroups': [{'id': 'EG000', 'title': 'Netupitant and Palonosetron+Dexamethasone-cycle 1', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle', 'otherNumAtRisk': 725, 'otherNumAffected': 551, 'seriousNumAtRisk': 725, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'Palonosetron+Dexamethasone-cycle 1', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle', 'otherNumAtRisk': 725, 'otherNumAffected': 507, 'seriousNumAtRisk': 725, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Netupitant and Palonosetron+Dexamethasone-multicycle Extension', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle', 'otherNumAtRisk': 635, 'otherNumAffected': 533, 'seriousNumAtRisk': 635, 'seriousNumAffected': 23}, {'id': 'EG003', 'title': 'Palonosetron+Dexamethasone-multicycle Extension', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle', 'otherNumAtRisk': 651, 'otherNumAffected': 527, 'seriousNumAtRisk': 651, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 96}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 138}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 141}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 173}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 182}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 226}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 238}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 59}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 70}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 69}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 49}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 57}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 253}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 253}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 152}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 151}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 47}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 41}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 42}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 45}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 43}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'seriousEvents': [{'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cytotoxic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Central venous catheterisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Device relatet infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Fibrin D dimer increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Venous recanalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Venous thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Endometrial hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Catheterisation venous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}, {'term': 'Anal fissure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 725, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 635, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (14.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}, {'value': '725', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Netupitant and Palonosetron Plus Dexamethasone', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle\n\nNetupitant and Palonosetron\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Palonosetron Plus Dexamethasone', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle\n\nPalonosetron\n\nDexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '76.9', 'groupId': 'OG000', 'lowerLimit': '73.7', 'upperLimit': '79.9'}, {'value': '69.5', 'groupId': 'OG001', 'lowerLimit': '66.1', 'upperLimit': '72.8'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.48', 'ciLowerLimit': '1.16', 'ciUpperLimit': '1.87', 'pValueComment': 'If superiority of netupitant/palonosetron was established for the CR delayed, CR acute and then CR overall at cycle 1 were to be tested according to a hierarchical procedure;no adjustment for multiplicity was needed.The a priori threshold was 0.050', 'estimateComment': 'Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.', 'groupDescription': 'The null hypothesis was rejected if the 2 sided p value from the Cochran Mantel Haenszel test was less than or equal to 0.050 and in the right direction i.e., the Odds Ratio (OR) was in favor of netupitant/palonosetron. Power was 90%.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '25-120 hours', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}, {'value': '725', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Netupitant and Palonosetron Plus Dexamethasone', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle\n\nNetupitant and Palonosetron\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Palonosetron Plus Dexamethasone', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle\n\nPalonosetron\n\nDexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '85.9', 'upperLimit': '90.5'}, {'value': '85.0', 'groupId': 'OG001', 'lowerLimit': '82.2', 'upperLimit': '87.4'}]}]}], 'analyses': [{'pValue': '0.047', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.37', 'ciLowerLimit': '1.0', 'ciUpperLimit': '1.87', 'pValueComment': 'If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.', 'groupDescription': 'CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '0-24 hours', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}, {'value': '725', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Netupitant and Palonosetron Plus Dexamethasone', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle\n\nNetupitant and Palonosetron\n\nDexamethasone'}, {'id': 'OG001', 'title': 'Palonosetron Plus Dexamethasone', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle\n\nPalonosetron\n\nDexamethasone'}], 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '77.4'}, {'value': '66.6', 'groupId': 'OG001', 'lowerLimit': '63.1', 'upperLimit': '70.0'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.47', 'ciLowerLimit': '1.17', 'ciUpperLimit': '1.85', 'pValueComment': 'If the null hypothesis for CR acute was rejected, analysis of the 2nd key secondary endpoint CR overall was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.', 'groupDescription': 'CR in the overall phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the overall phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '0-120 hours', 'unitOfMeasure': 'percentage of responders', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Netupitant and Palonosetron Plus Dexamethasone', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle\n\nNetupitant and Palonosetron\n\nDexamethasone'}, {'id': 'FG001', 'title': 'Palonosetron Plus Dexamethasone', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle\n\nPalonosetron\n\nDexamethasone'}], 'periods': [{'title': 'Cycle 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Intent-To-Treat: randomized patients', 'groupId': 'FG000', 'numSubjects': '726'}, {'comment': 'Intent-To-Treat: randomized patients', 'groupId': 'FG001', 'numSubjects': '729'}]}, {'type': 'Safety Population', 'achievements': [{'comment': 'Patients receiving netupitant/palonosetron combination', 'groupId': 'FG000', 'numSubjects': '725'}, {'comment': 'Patients receiving palonosetron', 'groupId': 'FG001', 'numSubjects': '725'}]}, {'type': 'Full Analysis Set', 'achievements': [{'comment': 'Patients receiving chemotherapy and randomized to netupitant/palonosetron combination', 'groupId': 'FG000', 'numSubjects': '724'}, {'comment': 'Patients receiving chemotherapy and randomized to palonosetron', 'groupId': 'FG001', 'numSubjects': '725'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '719'}, {'groupId': 'FG001', 'numSubjects': '719'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}]}, {'title': 'Multi-cycle Extension', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Patients scheduled to netupitant/palonosetron combination', 'groupId': 'FG000', 'numSubjects': '635'}, {'comment': 'Patients scheduled to palonosetron', 'groupId': 'FG001', 'numSubjects': '651'}]}, {'type': 'Safety Population', 'achievements': [{'comment': 'Patients receiving netupitant/palonosetron combination', 'groupId': 'FG000', 'numSubjects': '635'}, {'comment': 'Patients receiving palonosetron', 'groupId': 'FG001', 'numSubjects': '651'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Patients completing at least number of cycles they were scheduled to', 'groupId': 'FG000', 'numSubjects': '449'}, {'comment': 'Patients completing at least number of cycles they were scheduled to', 'groupId': 'FG001', 'numSubjects': '458'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '186'}, {'groupId': 'FG001', 'numSubjects': '193'}]}]}], 'preAssignmentDetails': '1455 patients randomized (ITT population), 1450 received study drug i.e. netupitant/palonosetron combination or palonosetron, both with dexamethasone, in cycle 1 (safety population-cycle 1), 1449 received chemotherapy and study drug (FAS), 1286 received study drug in multi-cycle extension (safety population-multi-cycle extension)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '725', 'groupId': 'BG000'}, {'value': '725', 'groupId': 'BG001'}, {'value': '1450', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Netupitant and Palonosetron Plus Dexamethasone', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle\n\nNetupitant and Palonosetron\n\nDexamethasone'}, {'id': 'BG001', 'title': 'Palonosetron Plus Dexamethasone', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle\n\nPalonosetron\n\nDexamethasone'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '10.66', 'groupId': 'BG000'}, {'value': '54.1', 'spread': '10.65', 'groupId': 'BG001'}, {'value': '53.9', 'spread': '10.65', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '711', 'groupId': 'BG000'}, {'value': '711', 'groupId': 'BG001'}, {'value': '1422', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '574', 'groupId': 'BG000'}, {'value': '579', 'groupId': 'BG001'}, {'value': '1153', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population ie patients receiving either netupitant/palonosetron combination or palonosetron, both plus dexamethasone'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1455}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'dispFirstSubmitDate': '2013-01-16', 'lastUpdateSubmitDate': '2014-11-19', 'studyFirstSubmitDate': '2011-04-19', 'dispFirstSubmitQcDate': '2013-01-16', 'resultsFirstSubmitDate': '2014-11-06', 'studyFirstSubmitQcDate': '2011-04-19', 'dispFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-19', 'studyFirstPostDateStruct': {'date': '2011-04-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1', 'timeFrame': '25-120 hours'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1', 'timeFrame': '0-24 hours'}, {'measure': 'Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication, at Cycle 1', 'timeFrame': '0-120 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chemotherapy-Induced Nausea and Vomiting']}, 'referencesModule': {'references': [{'pmid': '30968588', 'type': 'DERIVED', 'citation': 'Schwartzberg L, Karthaus M, Rossi G, Rizzi G, Borroni ME, Rugo HS, Jordan K, Hansen V. Fixed combination of oral NEPA (netupitant-palonosetron) for the prevention of acute and delayed chemotherapy-induced nausea and vomiting in patients receiving multiple cycles of chemotherapy: Efficacy data from 2 randomized, double-blind phase III studies. Cancer Med. 2019 May;8(5):2064-2073. doi: 10.1002/cam4.2091. Epub 2019 Apr 9.'}, {'pmid': '28285236', 'type': 'DERIVED', 'citation': 'Rugo HS, Rossi G, Rizzi G, Aapro M. Efficacy of NEPA (netupitant/palonosetron) across multiple cycles of chemotherapy in breast cancer patients: A subanalysis from two phase III trials. Breast. 2017 Jun;33:76-82. doi: 10.1016/j.breast.2017.02.017. Epub 2017 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. The objective of the study is to demonstrate that netupitant and palonosetron are more effective than palonosetron alone, to prevent nausea and vomiting induced by moderately emetogenic cancer chemotherapy after administration of repeated cycles of chemotherapy.', 'detailedDescription': 'NETU-08-18 is a two-arm clinical study assessing efficacy and safety of a single oral dose of netupitant and palonosetron, two antiemetic drugs, versus oral palonosetron, both given with oral dexamethasone. Study is organised in two phases: cycle-1 and a multi-cycle extension. Safety assessment is performed separately in cycle 1 (arm 1 and arm 2) and in multi-cycle extension (arm 3 and arm 4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Naïve to cytotoxic chemotherapy. Previous biological or hormonal therapy will be permitted.\n* Scheduled to receive first course of an anthracycline and cyclophosphamide containing moderately emetogenic chemotherapy (MEC) regimen for the treatment of a solid malignant tumor: cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. doxorubicin (more or equal to 40 mg/m2) or cyclophosphamide I.V. (500 to 1500 mg/m2) and I.V. epirubicin (more or equal to 60 mg/m2).\n* If scheduled to receive chemotherapy agents of minimal to low emetogenic potential they could be given on any day.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2.\n* Female patients of either non-childbearing potential or child-bearing potential with a commitment to use contraceptive methods throughout the clinical trial\n* Hematologic and metabolic status adequate for receiving a moderately emetogenic regimen based on laboratory criteria (Total Neutrophils,Platelets, Bilirubin, Liver enzymes, Serum Creatinine or Creatinine Clearance)\n\nThe following inclusion criteria must be checked prior inclusion at each cycle of the Multiple-Cycle Extension:\n\n* Participation in the study during the next cycle of chemotherapy is considered appropriate by the investigator Satisfactory study compliance in the preceding cycle of chemotherapy and related study procedures.\n* Scheduled to receive the same chemotherapy regimen as cycle 1\n* Adequate hematologic and metabolic status as defined for cycle 1\n\nExclusion Criteria:\n\n* If female, pregnant or lactating.\n* Current use of illicit drugs or current evidence of alcohol abuse.\n* Scheduled to receive any highly emetogenic chemotherapy (HEC) from Day 1 to Day 5 or moderately emetogenic chemotherapy (MEC) from Day 2 to Day 5 following the allowed MEC regimen.\n* Received or is scheduled to receive radiation therapy to the abdomen or the pelvis within 1 week prior to Day 1 or between Days 1 to 5 in cycle 1.\n* Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.\n* Symptomatic primary or metastatic central nervous system (CNS) malignancy.\n* Active peptic ulcer disease, gastrointestinal obstruction, increased intracranial pressure, hypercalcemia, an active infection or any uncontrolled medical condition (other than malignancy) that, in the opinion of the investigator, may confound the results of the study, represent another potential etiology for emesis and nausea (other than chemotherapy-induced nausea and vomiting, CINV) or pose unwarranted risks in administering the study drugs to the patient.\n* Known hypersensitivity or contraindication to 5-HT3 receptor antagonists or dexamethasone.\n* Previously received a neurokin-1 (NK1) receptor antagonist\n* Participation in a clinical trial involving oral netupitant administered in combination with palonosetron.\n* Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study.\n* Systemic corticosteroid therapy at any dose within 72 hours prior to Day 1 of cycle 1.\n* Scheduled to receive bone marrow transplantation and/or stem cell rescue therapy.\n* Any medication with known or potential antiemetic activity within 24 hours prior to Day 1 of cycle 1\n* Scheduled to receive any strong or moderate inhibitor of cytocrome P450 3A4 (CYP3A4) or its intake within 1 week prior to Day 1.\n* Scheduled to receive any of the following CYP3A4 substrates: terfenadine, cisapride, astemizole, pimozide.\n* Scheduled to receive any CYP3A4 inducer or its intake within 4 weeks prior to Day 1.\n* History or predisposition to cardiac conduction abnormalities, except for incomplete right bundle branch block.\n* History of risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome).\n* Severe cardiovascular diseases, including myocardial infarction within 3 months prior to Day 1, unstable angina pectoris, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic Congestive Heart Failure (CHF) New York Heart Association (NYHA) class III-IV, and severe uncontrolled arterial hypertension.\n* Any illness or condition that, in the opinion of the investigator, may confound the results of the study or pose unwarranted risks in administering the investigational product to the patient.\n* Concurrent medical condition that would preclude administration of dexamethasone such as systemic fungal infection or uncontrolled diabetes.\n\nThe following exclusion criteria must be checked prior inclusion at each cycle of the Multiple-Cycle Extension:\n\n* If female, pregnant or lactating\n* Active infection or uncontrolled disease except for malignancy.\n* Started any of the restricted medications.\n* Any vomiting, retching, or mild nausea within 24 hours prior to Day 1.'}, 'identificationModule': {'nctId': 'NCT01339260', 'briefTitle': 'An Efficacy and Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting', 'organization': {'class': 'INDUSTRY', 'fullName': 'Helsinn Healthcare SA'}, 'officialTitle': 'A Phase III Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of the Efficacy and Safety of Oral Netupitant Administered in Combination With Palonosetron and Dexamethasone Compared to Oral Palonosetron and Dexamethasone for the Prevention of Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy', 'orgStudyIdInfo': {'id': 'NETU-08-18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Netupitant and Palonosetron+dexamethasone-cycle 1', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle', 'interventionNames': ['Drug: Netupitant and Palonosetron', 'Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Palonosetron+dexamethasone-cycle 1', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle', 'interventionNames': ['Drug: Palonosetron', 'Drug: Dexamethasone']}, {'type': 'EXPERIMENTAL', 'label': 'Netupitant and Palonosetron+dexamethasone-multicycle extension', 'description': 'Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle', 'interventionNames': ['Drug: Netupitant and Palonosetron', 'Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Palonosetron+dexamethasone-multicycle extension', 'description': 'Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle', 'interventionNames': ['Drug: Palonosetron', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Netupitant and Palonosetron', 'type': 'DRUG', 'armGroupLabels': ['Netupitant and Palonosetron+dexamethasone-cycle 1', 'Netupitant and Palonosetron+dexamethasone-multicycle extension']}, {'name': 'Palonosetron', 'type': 'DRUG', 'armGroupLabels': ['Palonosetron+dexamethasone-cycle 1', 'Palonosetron+dexamethasone-multicycle extension']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'armGroupLabels': ['Netupitant and Palonosetron+dexamethasone-cycle 1', 'Netupitant and Palonosetron+dexamethasone-multicycle extension', 'Palonosetron+dexamethasone-cycle 1', 'Palonosetron+dexamethasone-multicycle extension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Anniston Oncology/Regional Medical Center', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Northwest Alabama Cancer Center', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'zip': '71913', 'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Genesis Cancer Centre', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'zip': '92879', 'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Cancer Care Medical Group Inc', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'zip': '92708', 'city': 'Fountain Valley', 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