Viewing Study NCT03743051

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Ignite Creation Date: 2025-12-24 @ 11:45 PM
Ignite Modification Date: 2026-01-19 @ 10:25 AM
Study NCT ID: NCT03743051
Status: COMPLETED
Last Update Posted: 2024-06-26
First Post: 2018-11-14
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D002100', 'term': 'Cachexia'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000593861', 'term': 'anamorelin'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'florin.muraru@helsinn.com', 'phone': '+41 91985 21 21', 'title': 'Florin Muraru', 'organization': 'Helsinn Healthcare SA'}, 'certainAgreement': {'otherDetails': 'The Sponsor has the sole right to first publication of the study data, which would be a multi-center publication. Investigators may publish the Study Data they obtained if they follow the conditions provided in the protocol. These include, but are not limited to: the multi-center publication has occurred; the Sponsor is given 60 days to review the document and possibly 60 more days to obtain Intellectual Property protections; and all Confidential Information is deleted, as requested by Sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected from the time of Informed Consent signature through Day 183 (+3) days post study drug administration on Day 1.', 'description': 'The "Serious Adverse Events" and "Other (Not Including Serious) Adverse Events" tables include only treatment-emergent AEs.', 'eventGroups': [{'id': 'EG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 82, 'seriousNumAtRisk': 159, 'deathsNumAffected': 27, 'seriousNumAffected': 43}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks', 'otherNumAtRisk': 159, 'deathsNumAtRisk': 159, 'otherNumAffected': 87, 'seriousNumAtRisk': 159, 'deathsNumAffected': 26, 'seriousNumAffected': 39}], 'otherEvents': [{'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 13, 'numAffected': 11}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 11, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 17, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 24, 'numAffected': 19}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 10, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Platelet Count Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Corona Virus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}], 'seriousEvents': [{'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Acute myocardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Cardiac tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Autoimmune colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Oesophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Small intestinal ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Large intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Osteonecrosis of jaw', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Urinary bladder haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Chemical peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 159, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 159, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 22.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Body Weight Over 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '1.938', 'spread': '0.285', 'groupId': 'OG000'}, {'value': '0.594', 'spread': '0.285', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.345', 'ciLowerLimit': '0.718', 'ciUpperLimit': '1.971', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.320', 'groupDescription': 'To declare anamorelin superior to placebo, both co-primary endpoints had to be significant.\n\nThe null hypothesis for mean change in body weight from baseline over 12 weeks (H0w) and the corresponding alternative hypothesis (H1w) were:\n\nH0w: MWa = MW; H1w: MWa ≠ MWp\n\nWhere MWa is the mean change in body weight from baseline over 12 weeks for the anamorelin arm and MWp is the mean change in body weight from baseline over 12 weeks for the placebo arm.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean change from baseline over 12 weeks.', 'description': 'This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.', 'unitOfMeasure': 'Change from baseline in body weight (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) Set included all randomized patients and was analyzed as per planned treatment.'}, {'type': 'PRIMARY', 'title': 'Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.816', 'spread': '0.383', 'groupId': 'OG000'}, {'value': '3.194', 'spread': '0.385', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1514', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.622', 'ciLowerLimit': '-0.228', 'ciUpperLimit': '1.472', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.434', 'groupDescription': 'To declare anamorelin superior to the placebo, both co-primary endpoints had to be significant.\n\nThe null hypothesis for mean change from baseline over 12 weeks in patient 5-IASS (H0A) and the corresponding alternative (H1A) were:\n\nH0A: MAa = MAp; H1A: MAa ≠ MAp\n\nWhere MAa is the mean change from baseline over 12 weeks in 5-IASS for the anamorelin arm and MAp is the mean change from baseline over 12 weeks in 5-IASS for the placebo arm.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The Multiple Imputation process (N=100) was performed leading to least squares mean (LSM) and standard error (SE) estimates using the ANOVA model (including treatment group and the 3 stratification factors at randomization as categorical covariates). The estimates were pooled using Rubin rule, with corresponding p-value for difference between treatment groups. The 95% confidence interval (CI) was calculated for each treatment group and for the pooled difference between the groups.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Mean change from baseline over 12 weeks.', 'description': 'This co-primary efficacy endpoint was mean change from baseline in 5-IASS (points) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.\n\nFAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients\' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Set included all randomized patients and was analyzed as per planned treatment.'}, {'type': 'SECONDARY', 'title': 'Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '9.871', 'spread': '0.476', 'groupId': 'OG000'}, {'value': '7.462', 'spread': '0.475', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.410', 'ciLowerLimit': '1.367', 'ciUpperLimit': '3.453', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.532', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Duration of treatment benefit from baseline over 12 weeks.', 'description': 'The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥0 kg.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Set included all randomized patients and was analyzed as per planned treatment.'}, {'type': 'SECONDARY', 'title': 'Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.967', 'spread': '0.434', 'groupId': 'OG000'}, {'value': '3.631', 'spread': '0.429', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0057', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.336', 'ciLowerLimit': '0.388', 'ciUpperLimit': '2.284', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.484', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Duration of treatment benefit from baseline over 12 weeks.', 'description': 'The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥1.5 kg.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Set included all randomized patients and was analyzed as per planned treatment.'}, {'type': 'SECONDARY', 'title': 'Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '10.523', 'spread': '0.362', 'groupId': 'OG000'}, {'value': '9.496', 'spread': '0.359', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0108', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.027', 'ciLowerLimit': '0.238', 'ciUpperLimit': '1.816', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.403', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Duration of treatment benefit from baseline over 12 weeks.', 'description': 'The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5-IASS of ≥0 points.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Set included all randomized patients and was analyzed as per planned treatment.'}, {'type': 'SECONDARY', 'title': 'Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}, {'value': '159', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '6.185', 'spread': '0.423', 'groupId': 'OG000'}, {'value': '5.650', 'spread': '0.426', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2605', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.535', 'ciLowerLimit': '-0.397', 'ciUpperLimit': '1.466', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.475', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'All secondary endpoints were analyzed using the same statistical model and multiple imputation approach as for the co-primary efficacy endpoints.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Duration of treatment benefit from baseline over 12 weeks.', 'description': 'The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5-IASS of ≥3 points.', 'unitOfMeasure': 'Weeks', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT Set included all randomized patients and was analyzed as per planned treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomized patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'Treated Patients', 'achievements': [{'groupId': 'FG000', 'numSubjects': '159'}, {'groupId': 'FG001', 'numSubjects': '159'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '76'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '83'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '15'}]}, {'type': 'Reported as "Other" in Clinical Study Report', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'Patients were enrolled at a total of 46 study sites in Bulgaria (4 sites), Hungary (5 sites), Italy (5 sites), Romania (6 sites), Russia (10 sites), Serbia (5 sites), and USA (11 sites). First Patient Enrollment (date of randomization) was on 05MAR2019.', 'preAssignmentDetails': "The protocol had pre-defined criteria regarding health and medication requirements to begin study drug administration, and if the patient's status for these requirements changed between screening and Study Day 1, treatment could not be initiated."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'BG000'}, {'value': '159', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '100 mg Anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.5', 'spread': '9.20', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '10.55', 'groupId': 'BG001'}, {'value': '63.4', 'spread': '9.95', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '148', 'groupId': 'BG001'}, {'value': '295', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '152', 'groupId': 'BG001'}, {'value': '306', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Romania', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '93', 'groupId': 'BG002'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.47', 'spread': '10.438', 'groupId': 'BG000'}, {'value': '172.09', 'spread': '9.910', 'groupId': 'BG001'}, {'value': '171.28', 'spread': '10.194', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '53.71', 'spread': '8.049', 'groupId': 'BG000'}, {'value': '54.49', 'spread': '8.627', 'groupId': 'BG001'}, {'value': '54.10', 'spread': '8.339', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '18.35', 'spread': '1.386', 'groupId': 'BG000'}, {'value': '18.24', 'spread': '1.578', 'groupId': 'BG001'}, {'value': '18.30', 'spread': '1.484', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Chemotherapy Line', 'classes': [{'title': 'First line', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '113', 'groupId': 'BG001'}, {'value': '225', 'groupId': 'BG002'}]}]}, {'title': 'Second line', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Third line', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anti-cancer Treatment', 'classes': [{'title': 'Immunotherapy', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': 'Non-immunotherapy', 'categories': [{'measurements': [{'value': '112', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '223', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '5-IASS Score', 'classes': [{'title': '≤10', 'categories': [{'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}]}]}, {'title': '>10', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Measure Description: FAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients\' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.', 'unitOfMeasure': 'Participants'}, {'title': 'NSCLC stage at study entry', 'classes': [{'categories': [{'title': 'Stage IIIA', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Stage IIIB', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}, {'title': 'Stage IV', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '249', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'American Joint Committee on Cancer (AJCC) staging for non-small cell lung cancer (NSCLC): The earliest stage of NSCLC is stage 0 (also called carcinoma in situ, or CIS). Other stages range from I through IV. As a rule, the lower the number, the less the cancer has spread. A higher number, such as stage IV, means cancer has spread more. And within a stage, an earlier letter (or number) means a lower stage.', 'unitOfMeasure': 'Participants'}, {'title': 'Body weight change within 6 months prior to screening', 'classes': [{'categories': [{'measurements': [{'value': '-12.04', 'spread': '7.160', 'groupId': 'BG000'}, {'value': '-11.05', 'spread': '6.489', 'groupId': 'BG001'}, {'value': '-11.54', 'spread': '6.840', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent change', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-13', 'size': 4036294, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-17T17:09', 'hasProtocol': True}, {'date': '2023-05-12', 'size': 936464, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-17T17:11', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'This was a double-blind study. The blinding of the study drugs was guaranteed by the use of anamorelin HCl film-coated tablets and matching placebo tablets. Patients were randomized using the Interactive Web Response System (IWRS). Any unblinding of the study treatment was performed using the IWRS.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Double-Blind, Placebo-Controlled, Multicenter Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'dispFirstSubmitDate': '2023-04-03', 'completionDateStruct': {'date': '2023-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-05', 'studyFirstSubmitDate': '2018-11-14', 'resultsFirstSubmitDate': '2024-04-18', 'studyFirstSubmitQcDate': '2018-11-14', 'dispFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-05', 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Body Weight Over 12 Weeks', 'timeFrame': 'Mean change from baseline over 12 weeks.', 'description': 'This co-primary efficacy endpoint was mean change from baseline in body weight (kg) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.'}, {'measure': 'Mean Change From Baseline in 5-item Anorexia Symptom Subscale (5-IASS) Over 12 Weeks', 'timeFrame': 'Mean change from baseline over 12 weeks.', 'description': 'This co-primary efficacy endpoint was mean change from baseline in 5-IASS (points) over 12 weeks in the anamorelin HCl group versus placebo group. Mean change was computed as sum of the changes from baseline over 12 weeks by the time of the last assessment (either week 12 or before in case of death), and then divided by the number of assessments (observed or imputed) from baseline up to the time of the last assessment.\n\nFAACT-A/CS (Functional Assessment Anorexia Cachexia Therapy) is a 12-item measure of patients\' perceptions of anorexia/cachexia symptoms and concerns. From this questionnaire, the 5-item section referring to anorexia symptoms (i.e., "good appetite," "interest in food drops," "food tastes unpleasant," "get full quickly," and "difficulty eating rich/heavy foods") was used to assess 5-IASS. The range of possible scores is 0-20. Higher scores indicate lower levels of symptom burden.'}], 'secondaryOutcomes': [{'measure': 'Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥0 kg)', 'timeFrame': 'Duration of treatment benefit from baseline over 12 weeks.', 'description': 'The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥0 kg.'}, {'measure': 'Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in Body Weight (≥1.5 kg)', 'timeFrame': 'Duration of treatment benefit from baseline over 12 weeks.', 'description': 'The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in body weight of ≥1.5 kg.'}, {'measure': 'Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥0 Points)', 'timeFrame': 'Duration of treatment benefit from baseline over 12 weeks.', 'description': 'The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5-IASS of ≥0 points.'}, {'measure': 'Duration of Treatment Benefit (Weeks) From Baseline Over 12 Weeks in 5-IASS (≥3 Points)', 'timeFrame': 'Duration of treatment benefit from baseline over 12 weeks.', 'description': 'The duration of treatment benefit over 12 weeks was measured as the period, or the sum of the periods, over 12 weeks (or less in case of death), in which the patient observed a change from baseline in 5-IASS of ≥3 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cachexia; Cancer', 'Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial was to compare the efficacy and safety of anamorelin HCl (the investigational drug) to that of placebo (tablet with no drug) in patients with advanced non-small cell lung cancer and cachexia (cancer-related weight loss). The main question it aimed to answer was as follows: Do patients who receive anamorelin HCl gain more body weight and show more improvement in anorexia symptoms than those who receive placebo.\n\nApproximately 316 patients were to be enrolled in the study. Of these patients, an equal number were to be assigned to each treatment group (anamorelin HCl or placebo). Participants were to take their assigned study drug by mouth once daily for a total of 24 weeks. During this treatment period, the patients were to visit the clinical study site every 3 weeks for health and other study-related assessments. Two weeks after the last treatment, patients were to receive a follow-up phone call.', 'detailedDescription': 'The study was a multicenter, randomized, double-blind, parallel-group, placebo controlled study to evaluate the efficacy and safety of anamorelin HCl. It was planned that approximately 316 patients with advanced NSCLC with cachexia were to be randomized 1:1 to anamorelin HCl 100 mg or placebo (158 patients per treatment group). The study treatment was to be taken orally once daily for a total of 24 weeks. Patients were instructed to take the study drug at least 1 hour before their first meal of the day.\n\nCentral randomization was stratified by line of systemic anti-cancer treatment (first line vs second line vs third line or higher), by type of anti-cancer therapy (immunotherapy vs non-immunotherapy), and by baseline score of the 5-item Anorexia Symptom Subscale (5-IASS) (≤10 vs \\>10).\n\nPatients who had never received anti-cancer treatment prior to entering the study but who met all eligibility criteria were eligible to enter the study and were assigned to receive first line treatment in the Interactive Web Response System (IWRS).\n\nPatients were to visit the site every 3 weeks for the study Treatment Period of 24 weeks. A follow-up telephone visit was to be scheduled at Week 26. Thus, patients were enrolled in the study for a maximum duration of 27 weeks (including a 1-week Screening Period, a 24-week Treatment Period, and a 2-week Follow-up Period). Each patient was scheduled to have a total of 10 planned visits plus 1 telephone contact for the Follow-up Visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Signed written informed consent\n2. Female or male ≥18 years of age\n3. Documented histologic or cytologic diagnosis of American Joint Committee on Cancer (AJCC) Stage III or IV NSCLC. Stage III patient must have unresectable disease\n4. Body mass index \\< 20 kg/m2 with involuntary weight loss of \\>2% within 6 months prior to screening\n5. Ongoing problems with appetite/eating associated with the underlying cancer, as determined by having score of ≤ 17 points on the 5-item Anorexia Symptom Scale and ≤ 37 points on the 12-item FAACT A/CS\n6. Patient receiving or not receiving systemic anti-cancer treatment at the time of screening are eligible to participate. Systemic anti-cancer treatment includes first, second, third treatment line with chemotherapy/radiation therapy, immunotherapy or targeted therapy.\n\n Patient not receiving systemic anti-cancer treatment is eligible if:\n 1. Not planning to receive anti-cancer treatment and/or at least 14 days must be elapsed from the completion of prior treatment at the day of screening, in case underwent previous cycle OR\n 2. Planning to receive anti-cancer treatment within 14 days from randomization and/or at least 14 days must be elapsed from the completion of prior treatment at the day of screening, in case underwent previous cycle OR\n 3. Patient on palliative care treatment\n7. ECOG performance status 0,1 or 2 at screening\n8. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN or if hepatic metastases are present ≤ 5 x ULN\n9. Adequate renal function, defined as creatinine ≤2 ULN, or calculated creatinine clearance \\>30 ml/minute\n10. Female patient shall be: a) of non-childbearing potential or b) of childbearing potential using reliable contraceptive measures and having a negative urine pregnancy test within 24 hours prior to first dose of investigational product.\n\n Notes:\n 1. Female patient of non-childbearing potential are defined as being in post-menopausal state since at least 1 year; or having documented surgical sterilization or hysterectomy at least 3 months before study participation.\n 2. Reliable contraceptive measures include implants, injectables, combined oral contraceptives, intrauterine devices, vasectomized partner or complete (long term) sexual abstinence.\n11. The patient must be willing and able to comply with the protocol tests and procedures.\n\nAll inclusion criteria were to be checked at screening visit (Visit 1). Inclusion criterion #10 was to be re-checked and verified at Day 1 (Visit 2).\n\nExclusion Criteria:\n\n1. Patient with other forms of lung cancer (e.g., small cell, neuroendocrine tumors)\n2. Woman who is pregnant or breast-feeding\n3. Reversible causes of reduced food intake, as determined by the Investigator. These causes may include but are not limited to:\n\n 1. NCI CTCAE Grade 3 or 4 oral mucositis,\n 2. NCI CTCAE Grade 3 or 4 GI disorders \\[nausea, vomiting, diarrhea, and constipation\\],\n 3. mechanical obstructions making patient unable to eat, or\n 4. severe depression\n4. Patient undergoing major surgery (central venous access placement and tumor biopsies are not considered major surgery) within 4 weeks prior to randomization. Patient must be well recovered from acute effects of surgery prior to screening. Patient should not have plans to undergo major surgical procedures during the treatment period.\n5. Patient currently taking androgenic compounds including but not limited to testosterone, testosterone-like agents, oxandrolone; megestrol acetate; corticosteroids; olanzapine, mirtazapine (however, long-term use of mirtazapine for depression for at least four weeks prior to screening is allowed); dronabinol; marijuana (cannabis); or any other prescription medication or off-label products intended to increase appetite or treat unintentional weight loss\n6. Patient with pleural effusion requiring thoracentesis, pericardial effusion requiring drainage, edema or evidence of ascites\n7. Patient with uncontrolled or significant cardiovascular disease, including:\n\n 1. History of myocardial infarction within the past 3 months\n 2. A-V block of second or third degree (may be eligible if currently have a pacemaker)\n 3. Unstable angina\n 4. Congestive heart failure within the past 3 months, if defined as NYHA class III-IV\n 5. Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes)\n 6. Uncontrolled hypertension (blood pressure \\>150 mm Hg systolic and \\>95 mm Hg diastolic)\n 7. Heart rate \\< 50 beats per minute on pre-entry electrocardiogram and patient is symptomatic\n8. Patient on drugs that may prolong the PR or QRS interval durations, such as any of the antiarrhythmic medications Class I (Fast sodium (Na) channel blockers)\n9. Patient unable to readily swallow oral tablets\n10. Patient with severe gastrointestinal disease (including esophagitis, gastritis, malabsorption)\n11. Patient with history of gastrectomy\n12. Patient with uncontrolled diabetes mellitus or unmonitored diabetes mellitus\n13. Patient with cachexia caused by other reasons, as determined by the investigator such as:\n\n 1. Severe COPD requiring use of home O2,\n 2. New York Heart Association (NYHA) class III-IV heart failure\n 3. AIDS\n 4. Uncontrolled thyroid disease\n14. Patient receiving strong CYP3A4 inhibitors within 14 days of randomization\n15. Patient currently receiving tube feedings or parenteral nutrition (either total or partial).\n16. Current excessive alcohol or illicit drug use\n17. Any condition, including the presence of laboratory abnormalities, which in the Investigator's opinion, places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study\n18. Enrollment in a previous study with anamorelin HCl\n19. Patient actively receiving a concurrent investigational agent, or having received an investigational agent within 28 days of Day 1\n\nAll exclusion criteria were to be checked at screening visit (Visit 1). Exclusion Criteria #3, 5, 6, 7g, and 9 were to be re-checked and verified before study drug administration (Visit 2)."}, 'identificationModule': {'nctId': 'NCT03743051', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Helsinn Healthcare SA'}, 'officialTitle': 'A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Anamorelin HCl for the Treatment of Malignancy Associated Weight Loss and Anorexia in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)', 'orgStudyIdInfo': {'id': 'ANAM-17-20'}, 'secondaryIdInfos': [{'id': '2018-002926-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '100 mg anamorelin HCl', 'description': '100 mg anamorelin HCl (administered as film-coated tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks', 'interventionNames': ['Drug: Anamorelin Hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo (administered as matching placebo tablets in fasted condition) was to be taken orally once daily for a total of 24 weeks', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Anamorelin Hydrochloride', 'type': 'DRUG', 'description': '100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)', 'armGroupLabels': ['100 mg anamorelin HCl']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Placebo (administered as matching placebo tablets in the fasted condition)', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85745', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Chen', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'CARTI Cancer Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'The Oncology Insitute of Hope and Innovation', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '06062', 'city': 'Plainville', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford HealthCare Cancer Institute at the Hospital of Central Connecticut', 'geoPoint': {'lat': 41.67454, 'lon': -72.85816}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': '21st Century Oncology', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32763', 'city': 'Orange City', 'state': 'Florida', 'country': 'United States', 'facility': 'Mid Florida Hematology and Oncology Center', 'geoPoint': {'lat': 28.94888, 'lon': -81.29867}}, {'zip': 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