Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-30 @ 3:11 PM
Study NCT ID:
NCT01387269
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2011-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013851', 'term': 'Thinness'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'richard.bourne@helsinn.com', 'phone': '732-603-2852', 'title': 'Richard K. Bourne, Ph.D.', 'organization': 'Helsinn Therapeutics (US), Inc.'}, 'certainAgreement': {'otherDetails': 'The Sponsor intends to publish the complete study results in a timely manner that is appropriate to the project. Separate publication of a portion of the study results by any PI is discouraged.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events that occurred during the clinical trial, commenced with the first dose of study drug through the 28 day post-treatment follow-up visit.', 'description': 'Adverse events that occurred following the signature of the informed consent, but prior to the first dose of study drug were not reported as adverse events in this trial. The adverse event reporting period also ended if the patient began an alternative therapy within 28 days of the last administration of study drug. The Safety Population, defined as all randomized patients who received any study drug, was used for all safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'Anamorelin HCl', 'description': 'Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.', 'otherNumAtRisk': 320, 'otherNumAffected': 182, 'seriousNumAtRisk': 320, 'seriousNumAffected': 82}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.', 'otherNumAtRisk': 161, 'otherNumAffected': 84, 'seriousNumAtRisk': 161, 'seriousNumAffected': 48}], 'otherEvents': [{'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 78, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 20, 'numAffected': 14}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 52, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 40, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 14, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 30, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 16, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 24, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 179, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 114, 'numAffected': 66}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 34, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 34, 'numAffected': 22}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 42, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 34, 'numAffected': 23}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 23, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 28, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 16, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 44, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 21, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 41, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Inferior vena caval occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 24, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ischaemic cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopulmonary hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colitis ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 320, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 161, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Lean Body Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anamorelin HCl', 'description': 'Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.61', 'upperLimit': '1.36'}, {'value': '-0.47', 'groupId': 'OG001', 'lowerLimit': '-1.00', 'upperLimit': '0.21'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Superiority analysis', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change in Lean Body Mass from Baseline Over 12 Weeks', 'description': 'Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.'}, {'type': 'PRIMARY', 'title': 'Change in Handgrip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '316', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anamorelin HCl', 'description': 'Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.10', 'groupId': 'OG000', 'lowerLimit': '-1.69', 'upperLimit': '-0.40'}, {'value': '-1.58', 'groupId': 'OG001', 'lowerLimit': '-2.99', 'upperLimit': '-1.14'}]}]}], 'analyses': [{'pValue': '0.1475', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Superiority analysis', 'statisticalMethod': 'Wilcoxon rank sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks', 'description': 'Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.', 'unitOfMeasure': 'kg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population. Some patients in the ITT population were excluded from the primary LBM/HGS analysis (i.e., multiple imputations/ranking method) if they survived to Week 12 but missed their baseline covariates including LBM, HGS, or ECOG OR had Week 6 and Week 12 outcomes that were outside the visit windows.'}, {'type': 'SECONDARY', 'title': 'Change in A/CS Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anamorelin HCl', 'description': 'Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.12', 'spread': '0.752', 'groupId': 'OG000'}, {'value': '1.92', 'spread': '0.805', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0004', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Superiority analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks', 'description': 'The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).\n\nThe 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Change in FACIT-F Fatigue Domain Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anamorelin HCl', 'description': 'Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.886', 'groupId': 'OG000'}, {'value': '-1.19', 'spread': '0.933', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0544', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Superiority analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks', 'description': 'The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).\n\nThe 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best).', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Change in Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Anamorelin HCl', 'description': 'Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.20', 'spread': '0.326', 'groupId': 'OG000'}, {'value': '0.14', 'spread': '0.363', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Superiority analysis', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Change in Body Weight from Baseline Over 12 Weeks', 'description': 'Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anamorelin HCl', 'description': 'Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '323'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'ITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '323'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'MITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '284'}, {'groupId': 'FG001', 'numSubjects': '141'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '320'}, {'groupId': 'FG001', 'numSubjects': '161'}]}, {'type': 'COMPLETED', 'comment': 'A patient was considered to have completed the study if the patient completed Week 12/Day 85 Visit.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '231'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '92'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Unrelated AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by patient', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Study drug-related AE', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Approximately 477 patients with advanced NSCLC-C (defined as unresectable Stage III and Stage IV and a weight loss of ≥ 5% body weight within 6 months prior to screening or a screening body mass index \\[BMI\\] \\< 20 kg/m2) were to be randomized 2:1 to anamorelin HCl 100 mg or placebo.', 'preAssignmentDetails': 'Central randomization stratified patients by geographic region, by chemotherapy and/or radiation therapy status and by weight loss over prior 6 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '323', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '484', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Anamorelin HCl', 'description': 'Active drug; 100 mg tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before the first meal of the day.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '215', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '320', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '247', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '368', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '133', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}, {'title': 'Belarus', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}, {'title': 'Slovenia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Geographic region', 'classes': [{'categories': [{'title': 'North America', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'West Europe', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '184', 'groupId': 'BG002'}]}, {'title': 'East Europe + Russia', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '248', 'groupId': 'BG002'}]}, {'title': 'Australia', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The intent-to-treat (ITT) Population included all randomized patients.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 484}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'dispFirstSubmitDate': '2014-02-12', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-26', 'studyFirstSubmitDate': '2011-06-30', 'dispFirstSubmitQcDate': '2014-02-12', 'resultsFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2011-06-30', 'dispFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-09', 'studyFirstPostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Lean Body Mass', 'timeFrame': 'Change in Lean Body Mass from Baseline Over 12 Weeks', 'description': 'Change in Lean Body Mass (LBM) from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.'}, {'measure': 'Change in Handgrip Strength', 'timeFrame': 'Change in Handgrip Strength of the Non-Dominant Hand from Baseline Over 12 Weeks', 'description': 'Change in Handgrip Strength (HGS) of the non-dominant hand from baseline over 12 weeks for the ITT Population. Change from baseline over 12 weeks was defined as the average of the change from baseline at Week 6 and the change from baseline at Week 12.'}], 'secondaryOutcomes': [{'measure': 'Change in A/CS Domain Score', 'timeFrame': 'Change in FAACT A/CS Domain Score from Baseline Over 12 Weeks', 'description': 'The Functional Assessment of Anorexia/Cachexia Treatment (FAACT) Additional Concerns Subscale (A/CS domain) is a 12-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).\n\nThe 12-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the A/CS domain ranges from 0 (worst) to 48 (best).'}, {'measure': 'Change in FACIT-F Fatigue Domain Score', 'timeFrame': 'Change in FACIT-F Fatigue Domain Score from Baseline Over 12 Weeks', 'description': 'The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) fatigue domain is a 13-item scale that is part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System. Each item is answered on a 5-point Likert scale ranging from 0 (not at all) to 4 (very much).\n\nThe 13-items are summed together to obtain the domain score. Note that negatively phrased questions are reverse scored so that higher scores always represent improvement/less symptom burden. The total possible score for the FACIT-F fatigue domain ranges from 0 (worst) to 52 (best).'}, {'measure': 'Change in Body Weight', 'timeFrame': 'Change in Body Weight from Baseline Over 12 Weeks', 'description': 'Change in body weight (BW) from baseline overall (i.e., over 12 weeks) for the MITT Population.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cachexia', 'Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '39992021', 'type': 'DERIVED', 'citation': 'Laird BJA, Skipworth R, Bonomi PD, Fallon M, Kaasa S, Giorgino R, McMillan DC, Currow DC. Anamorelin Efficacy in Non-Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2. J Cachexia Sarcopenia Muscle. 2025 Feb;16(1):e13732. doi: 10.1002/jcsm.13732.'}, {'pmid': '28472437', 'type': 'DERIVED', 'citation': 'Currow D, Temel JS, Abernethy A, Milanowski J, Friend J, Fearon KC. ROMANA 3: a phase 3 safety extension study of anamorelin in advanced non-small-cell lung cancer (NSCLC) patients with cachexia. Ann Oncol. 2017 Aug 1;28(8):1949-1956. doi: 10.1093/annonc/mdx192.'}, {'pmid': '26906526', 'type': 'DERIVED', 'citation': 'Temel JS, Abernethy AP, Currow DC, Friend J, Duus EM, Yan Y, Fearon KC. Anamorelin in patients with non-small-cell lung cancer and cachexia (ROMANA 1 and ROMANA 2): results from two randomised, double-blind, phase 3 trials. Lancet Oncol. 2016 Apr;17(4):519-531. doi: 10.1016/S1470-2045(15)00558-6. Epub 2016 Feb 20.'}]}, 'descriptionModule': {'briefSummary': 'The administration of Anamorelin in patients with Stage III-IV non-small cell lung cancer-cachexia (NSCLC-C) is expected to increase appetite, lean body mass, weight gain, and muscle strength.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and efficacy of Anamorelin in patients with non-small cell lung cancer-cachexia (NSCLC-C). The primary efficacy analysis will include the treatment difference in the change in lean body mass and physical function. Pharmacokinetic (PK) samples will also be collected at Day 43 visit for population PK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented diagnosis of unresectable Stage III or Stage IV NSCLC\n* Patients may be receiving maintenance chemotherapy\n* Patients planning to initiate a new chemotherapy and/or radiation therapy regimen may do so only within ± 14 days of randomization\n* Patients may have completed a chemotherapy and/or radiation therapy and/or have no plan to initiate a new regimen within 12 weeks from randomization; at least 14 days must elapse from the completion of the chemotherapy and/or radiation therapy prior to randomization\n* Involuntary weight loss of ≥5% body weight within 6 months prior to screening or a screening body mass index (BMI) \\<20 kg/m2\n* Body mass index ≤30 kg/m2\n* Life expectancy of \\>4 months at time of screening\n* ECOG performance status ≤2\n* Adequate hepatic function, defined as AST and ALT levels ≤5 x upper limit of normal\n* Adequate renal function, defined as creatinine ≤2 x upper limit of normal, or calculated creatinine clearance \\>30 ml/minute\n* Ability to understand and comply with the procedures for the HGS evaluation\n* If a woman of childbearing potential or a fertile man, he/she must agree to use an effective form of contraception during the study and for 30 days following the last dose of study drug (an effective form of contraception is abstinence, a hormonal contraceptive, or a double-barrier method)\n* Must be willing and able to give signed informed consent and, in the opinion of the Investigator, to comply with the protocol tests and procedures\n\nExclusion Criteria:\n\n* Other forms of lung cancer (e.g., small cell, mesothelioma)\n* Women who are pregnant or breast-feeding\n* Known HIV, hepatitis (B\\&C), or active tuberculosis\n* Had major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization; patients must be well recovered from acute effects of surgery prior to screening; patients should not have plans to undergo major surgical procedures during the treatment period\n* Currently taking prescription medications intended to increase appetite or treat weight loss; these include, but are not limited to, testosterone, androgenic compounds, megestrol acetate, methylphenidate, and dronabinol\n* Inability to readily swallow oral tablets; patients with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption, or obstructive symptoms) or intractable or frequent vomiting are excluded\n* Has an active, uncontrolled infection\n* Has uncontrolled diabetes mellitus\n* Has untreated clinically relevant hypothyroidism\n* Has known or symptomatic brain metastases\n* Receiving strong CYP3A4 inhibitors within 14 days of randomization\n* Receiving tube feedings or parenteral nutrition (either total or partial); patients must have discontinued these treatments for at least 6 weeks prior to Day 1, and throughout the study duration\n* Other clinical diagnosis, ongoing or intercurrent illness that in the Investigator's opinion would prevent the patient's participation\n* Has had previous exposure to Anamorelin HCl\n* Patients actively receiving a concurrent investigational agent"}, 'identificationModule': {'nctId': 'NCT01387269', 'briefTitle': 'Safety and Efficacy of Anamorelin HCl in Patients With Non-Small Cell Lung Cancer-Cachexia (ROMANA 1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Helsinn Therapeutics (U.S.), Inc'}, 'officialTitle': 'Anamorelin HCl in the Treatment of Non-Small Cell Lung Cancer-Cachexia (NSCLC-C): A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of Anamorelin HCl in Patients With NSCLC-C', 'orgStudyIdInfo': {'id': 'HT-ANAM-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '100 mg QD', 'description': 'Anamorelin HCL 100 mg will be administered daily', 'interventionNames': ['Drug: Anamorelin HCl']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Anamorelin HCl', 'type': 'DRUG', 'description': 'Anamorelin HCl will be orally administered daily at least one hour before meal', 'armGroupLabels': ['100 mg QD']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'city': 'Glendale', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'city': 'Riverside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'city': 'Quincy', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 39.9356, 'lon': -91.40987}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Northport', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.90093, 'lon': -73.34317}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Brest', 'country': 'Belarus', 'geoPoint': {'lat': 52.10894, 'lon': 23.71749}}, {'city': 'Lesnoy', 'country': 'Belarus', 'geoPoint': {'lat': 51.8625, 'lon': 26.7547}}, {'city': 'Minsk', 'country': 'Belarus', 'geoPoint': {'lat': 53.90019, 'lon': 27.56653}}, {'city': 'Antwerp', 'country': 'Belgium', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Brussels', 'country': 'Belgium', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Genk', 'country': 'Belgium', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Liège', 'country': 'Belgium', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'city': 'Sault Ste. 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