Viewing Study NCT00619359

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Ignite Creation Date: 2025-12-24 @ 2:48 PM
Ignite Modification Date: 2026-02-02 @ 5:46 AM
Study NCT ID: NCT00619359
Status: COMPLETED
Last Update Posted: 2017-03-21
First Post: 2008-01-28
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Canada', 'Chile', 'Colombia', 'Denmark', 'Germany', 'Guatemala', 'Hong Kong', 'Hungary', 'India', 'Italy', 'Lithuania', 'Mexico', 'Netherlands', 'New Zealand', 'Panama', 'Peru', 'Poland', 'Portugal', 'Romania', 'Russia', 'South Africa', 'South Korea', 'Spain', 'Sweden', 'United States', 'Venezuela']}, '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': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'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': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "AEs were collected starting from the Pre-Study Visit (Day -30 to Day -1) up to 14 days after the patient's last dose of study drug.", 'description': 'Severe infusion site pain, severe infusion site erythema and/or severe infusion site induration, as well as any episode of infusion site thrombophlebitis were designated Events of Clinical Interest (ECI) and evaluated using a predefined severity assessment scale.', 'eventGroups': [{'id': 'EG000', 'title': 'Fosaprepitant', 'description': 'Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.\n\n4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.', 'otherNumAtRisk': 1143, 'otherNumAffected': 636, 'seriousNumAtRisk': 1143, 'seriousNumAffected': 148}, {'id': 'EG001', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.\n\n6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables.', 'otherNumAtRisk': 1169, 'otherNumAffected': 679, 'seriousNumAtRisk': 1169, 'seriousNumAffected': 157}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 16}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 25}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 10}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 35}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 111}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 86}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 95}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 38}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 58}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 129}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 56}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 32}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 13}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 17}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 12}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 74}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 101}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 32}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 17}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 34}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 48}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 19}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 15}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 74}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 16}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 27}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 13}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Diplopia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Duodenal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Faecaloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Gastric ulcer perforation', 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'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Cognitive disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Spinal cord compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Choking', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hydropneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pulmonary thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Arterial thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1143, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1169, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1106', 'groupId': 'OG000'}, {'value': '1134', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosaprepitant', 'description': 'Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.'}, {'id': 'OG001', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '795', 'groupId': 'OG000'}, {'value': '820', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '3.3', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.7', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'If the CI for the difference in response rates (Fosaprepitant minus Aprepitant), calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the overall phase. Study had 90% power to detect non-inferiority for this outcome measure.'}], 'paramType': 'NUMBER', 'timeFrame': 'Overall (in the 120 hours following initiation of cisplatin chemotherapy).', 'description': 'The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment.'}, {'type': 'SECONDARY', 'title': 'A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1106', 'groupId': 'OG000'}, {'value': '1133', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosaprepitant', 'description': 'Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.'}, {'id': 'OG001', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '822', 'groupId': 'OG000'}, {'value': '841', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '3.7', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.6', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥7.3 percentage points, fosaprepitant was considered at least as effective as aprepitant for Complete Response in the delayed phase.'}], 'paramType': 'NUMBER', 'timeFrame': 'Delayed phase (25 to 120 hours following initiation of cisplatin).', 'description': 'The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 1 patient (aprepitant group) had no delayed phase data, and was not included in this analysis.'}, {'type': 'SECONDARY', 'title': 'No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1106', 'groupId': 'OG000'}, {'value': '1132', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosaprepitant', 'description': 'Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.'}, {'id': 'OG001', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.'}], 'classes': [{'categories': [{'measurements': [{'value': '806', 'groupId': 'OG000'}, {'value': '844', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '2.0', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.6', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'If the CI for the difference in response rates, calculated using the methodology of Miettinen and Nurminen, had a lower limit ≥8.2 percentage points, fosaprepitant was considered at least as effective as aprepitant for No Vomiting in the overall phase.'}], 'paramType': 'NUMBER', 'timeFrame': 'Overall (the 120 hours following initiation of cisplatin chemotherapy)', 'description': 'The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS (Full Analysis Set) patient population was used for all efficacy evaluations and included patients who: 1) received at least one dose of study therapy, 2) received cisplatin chemotherapy, and 3) had at least one post-treatment efficacy assessment. 2 patients (aprepitant group) had no vomiting data, and were excluded from this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fosaprepitant', 'description': 'Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.'}, {'id': 'FG001', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1147'}, {'groupId': 'FG001', 'numSubjects': '1175'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1080'}, {'groupId': 'FG001', 'numSubjects': '1094'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '81'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Patients were recruited from 149 medical centers worldwide. The recruitment period was from 12 Feb 08 through 8 Jun 09.', 'preAssignmentDetails': 'Cisplatin-naïve patients scheduled to receive cisplatin chemotherapy at a dose of 70 mg/m2 or higher for a documented solid malignancy were screened up to 30 days prior to initiation of chemotherapy. Screening included a complete medical history and physical exam. Informed consent was obtained for patients who agreed to participate in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1147', 'groupId': 'BG000'}, {'value': '1175', 'groupId': 'BG001'}, {'value': '2322', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fosaprepitant', 'description': 'Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.'}, {'id': 'BG001', 'title': 'Aprepitant', 'description': 'Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.2', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '86'}, {'value': '55.9', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '82'}, {'value': '55.6', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '425', 'groupId': 'BG000'}, {'value': '427', 'groupId': 'BG001'}, {'value': '852', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '722', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '1470', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '306', 'groupId': 'BG001'}, {'value': '602', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': 'Multi-Racial', 'categories': [{'measurements': [{'value': '149', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '648', 'groupId': 'BG000'}, {'value': '655', 'groupId': 'BG001'}, {'value': '1303', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of Motion Sickness', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '1143', 'groupId': 'BG000'}, {'value': '1166', 'groupId': 'BG001'}, {'value': '2309', 'groupId': 'BG002'}]}]}, {'title': 'No Data - Assessment Not Completed', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Includes treated patients only.', 'unitOfMeasure': 'Participants'}, {'title': 'History of Vomiting with Pregnancy', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '420', 'groupId': 'BG000'}, {'value': '421', 'groupId': 'BG001'}, {'value': '841', 'groupId': 'BG002'}]}]}, {'title': 'Female Patients with No Data - No Assessment', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Not Applicable - Male Patients', 'categories': [{'measurements': [{'value': '722', 'groupId': 'BG000'}, {'value': '748', 'groupId': 'BG001'}, {'value': '1470', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Measure is specific to female treated patients only.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2008-01-28', 'resultsFirstSubmitDate': '2010-01-19', 'studyFirstSubmitQcDate': '2008-02-11', 'lastUpdatePostDateStruct': {'date': '2017-03-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-01-19', 'studyFirstPostDateStruct': {'date': '2008-02-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).', 'timeFrame': 'Overall (in the 120 hours following initiation of cisplatin chemotherapy).', 'description': 'The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.'}], 'secondaryOutcomes': [{'measure': 'A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).', 'timeFrame': 'Delayed phase (25 to 120 hours following initiation of cisplatin).', 'description': 'The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy.'}, {'measure': 'No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)', 'timeFrame': 'Overall (the 120 hours following initiation of cisplatin chemotherapy)', 'description': 'The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy.'}]}, 'conditionsModule': {'conditions': ['Chemotherapy-Induced Nausea and Vomiting (CINV)']}, 'referencesModule': {'references': [{'pmid': '21383291', 'type': 'RESULT', 'citation': 'Grunberg S, Chua D, Maru A, Dinis J, DeVandry S, Boice JA, Hardwick JS, Beckford E, Taylor A, Carides A, Roila F, Herrstedt J. Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with cisplatin therapy: randomized, double-blind study protocol--EASE. J Clin Oncol. 2011 Apr 10;29(11):1495-501. doi: 10.1200/JCO.2010.31.7859. Epub 2011 Mar 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater\n* Patient is post menopausal or, if premenopausal, must use double-barrier contraception\n\nExclusion Criteria:\n\n* Patient has symptomatic primary or metastatic CNS malignancy\n* Patient has received or will receive Radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 though Day 6\n* Patient has vomited in the 24 hours prior to treatment Day 1\n* Patient has an active infection; Patient uses illicit drugs or has current evidence of alcohol abuse\n* Patient is pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT00619359', 'acronym': 'EASE', 'briefTitle': 'Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy', 'orgStudyIdInfo': {'id': '0517-017'}, 'secondaryIdInfos': [{'id': 'MK0517-017'}, {'id': '2007_594'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Arm 1: study medication', 'interventionNames': ['Drug: Comparator: fosaprepitant dimeglumine', 'Drug: Dexamethasone', 'Drug: Ondansetron']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Arm 2: Active comparator', 'interventionNames': ['Drug: Comparator: Aprepitant', 'Drug: Dexamethasone', 'Drug: Ondansetron']}], 'interventions': [{'name': 'Comparator: fosaprepitant dimeglumine', 'type': 'DRUG', 'description': 'single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1.', 'armGroupLabels': ['1']}, {'name': 'Comparator: Aprepitant', 'type': 'DRUG', 'description': 'Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3).', 'armGroupLabels': ['2']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Oral dose of 12 mg of dexamethasone on Day 1, 8 mg on Day 2, and 8 mg twice a day on Days 3-4.', 'armGroupLabels': ['1']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'description': 'Oral dose of 12 mg of dexamethasone on Day 1, and 8 mg on Days 2-4.', 'armGroupLabels': ['2']}, {'name': 'Ondansetron', 'type': 'DRUG', 'description': 'single IV dose of 32 mg of ondansetron on Day 1.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}