Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT01767857
Status:
TERMINATED
Last Update Posted:
2021-06-29
First Post:
2013-01-08
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604877', 'term': 'bermekimab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Product Development Portfolio Leader', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 18 months', 'description': 'Safety analysis included the safety population, defined as enrolled participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months).', 'otherNumAtRisk': 411, 'deathsNumAtRisk': 411, 'otherNumAffected': 324, 'seriousNumAtRisk': 411, 'deathsNumAffected': 28, 'seriousNumAffected': 169}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).', 'otherNumAtRisk': 200, 'deathsNumAtRisk': 200, 'otherNumAffected': 167, 'seriousNumAtRisk': 200, 'deathsNumAffected': 13, 'seriousNumAffected': 84}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 20}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Sinus Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 109}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 13}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 51}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 11}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 27}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pericardial Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Anorectal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gastric Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gastrointestinal Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Large Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Large Intestine Perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Lower Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Malignant Bowel Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Oesophageal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Oesophageal Varices Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Rectal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Rectal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Small Intestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Small Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Subileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Upper Gastrointestinal Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Adverse Drug Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Disease Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'General Physical Health Deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Localised Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Performance Status Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Bile Duct Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Bile Duct Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Cholangitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Cholestasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hepatic Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Jaundice Cholestatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Liver Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Abdominal Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Catheter Site Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Catheter Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Kidney Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 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'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Skin Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Thrombophlebitis Septic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 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'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Spinal Compression Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Stoma Site Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Thoracic Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Toxicity to Various Agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Urinary Tract Stoma Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Urostomy Complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Blood Culture Positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Gamma-Glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Failure to Thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypernatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Bone Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Musculoskeletal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pain in Extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Spinal Pain', 'stats': 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'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Colorectal Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Colorectal Cancer Metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Malignant Neoplasm Progression', 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{'term': 'Neoplasm Progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pelvic Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Balance Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Brain Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Loss of Consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Spinal Cord Compression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Completed Suicide', 'stats': 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'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Urinary Incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Pain Management', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Ureteral Stent Removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Circulatory Collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 411, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 200, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '6.2'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '6.2'}]}]}], 'analyses': [{'pValue': '0.613', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 18 months', 'description': 'Overall survival time was defined as the duration from the date of randomization until death or last follow-up. OS was summarized by Kaplan-Meier method and compared between the treatment groups using un-adjusted log-rank test.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified intent-to-treat (mITT) population included all participants who were randomized and received at least one infusion of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 mg/kg Xilonix (MABp1) via IV injection once every 2 weeks until evidence of radiographic or clinical progression along with BSC (up to 18 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.51', 'spread': '0.158', 'groupId': 'OG000'}, {'value': '-0.21', 'spread': '0.231', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'Change from baseline in LBM as measured by Dexa scans was reported. DEXA is an X-ray imaging modality used to determine the mass of one material in the presence of another material, using the knowledge of their unique X-ray attenuation at different energies.', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The per protocol (PP) population was defined as participants that had baseline and follow up values for both the DEXA assessment and the European Organization for Research and Treatment of Cancer (EORTC) questionnaire.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 mg/kg Xilonix (MABp1) via IV injection once every 2 weeks until evidence of radiographic or clinical progression along with BSC (up to 18 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}], 'classes': [{'title': 'Global Health Status/Qol', 'categories': [{'measurements': [{'value': '-6.64', 'spread': '1.392', 'groupId': 'OG000'}, {'value': '-8.16', 'spread': '2.041', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '8.50', 'spread': '1.707', 'groupId': 'OG000'}, {'value': '10.27', 'spread': '2.503', 'groupId': 'OG001'}]}]}, {'title': 'Fatigue', 'categories': [{'measurements': [{'value': '7.42', 'spread': '1.516', 'groupId': 'OG000'}, {'value': '8.82', 'spread': '2.223', 'groupId': 'OG001'}]}]}, {'title': 'Appetite Loss', 'categories': [{'measurements': [{'value': '9.34', 'spread': '2.010', 'groupId': 'OG000'}, {'value': '11.84', 'spread': '2.947', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.541', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical Analysis for Global Health Status/Qol', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.560', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical Analysis for Pain', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.603', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical Analysis for Fatigue', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.485', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Statistical Analysis for Appetite Loss', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'The EORTC QLQ-C30 questionnaire incorporates nine multi-item scales: 5 functional scales (physical, cognitive, role, emotional, and social); 3 symptom scales (pain, fatigue, and appetite loss) and a Global Health Status/QoL scale. Each item, except Global Health Status, is answered on a four-point scale (1-4): 1-not at all, 2-a little, 3-quite a bit, 4-very much. Response to Global Health Status is measured on a 1 to 7 scale. "1" being very poor and "7" being excellent. Each scale (symptom scale \\[pain, fatigue, and appetite loss\\] and Global Health Status/Quality of Life \\[QoL\\] scale) was linearly transformed to be in range from 0-100 where a higher score represents good health status, while lower scores indicate poor health status. As planned, the data for symptom scales (pain, fatigue, appetite loss) and a Global Health Status/QoL scale was evaluated and reported.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as participants that had baseline and follow up values for both the DEXA assessment and the EORTC questionnaire.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Platelet Counts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 mg/kg Xilonix (MABp1) via IV injection once every 2 weeks until evidence of radiographic or clinical progression along with BSC (up to 18 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '5.50', 'spread': '4.721', 'groupId': 'OG000'}, {'value': '16.19', 'spread': '7.082', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.210', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 8', 'description': 'Change from baseline in platelet counts up to Week 8 was evaluated.', 'unitOfMeasure': '1000 cells/cubic millimeter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The PP population was defined as participants that had baseline and follow up values for both the DEXA assessment and the EORTC questionnaire.'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 mg/kg Xilonix (MABp1) via IV injection once every 2 weeks until evidence of radiographic or clinical progression along with BSC (up to 18 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '2.1'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.1'}]}]}], 'analyses': [{'pValue': '0.768', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 18 Months', 'description': 'PFS was defined as time from randomization to tumor progression or death. Progressive Disease defined as increase in tumor burden greater than or equals to (\\>=) 25 (%) percent relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented. Participants surviving without disease progression at end of study were censored. PFS was compared by Kaplan-Meier method using log-rank test.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intent-to-treat (ITT) population consisted of all randomized participants.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Objective Response (OR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'OG000'}, {'value': '200', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 mg/kg Xilonix (MABp1) via IV injection once every 2 weeks until evidence of radiographic or clinical progression along with BSC (up to 18 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'description': 'The percentage of OR was estimated by dividing the total number of confirmed complete response (CR) and partial response (PR) by the total number of participants randomized where CR was complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented and PR was decrease in tumor burden \\>= 50 % relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT population included all participants who were randomized and received at least one infusion of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Disease Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '296', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 mg/kg Xilonix (MABp1) via IV injection once every 2 weeks until evidence of radiographic or clinical progression along with BSC (up to 18 months).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 18 months', 'description': 'Percentage of participants who achieved disease control was estimated by dividing the total number of confirmed CRs, PRs and stable disease (SD) by the total number of participants randomized where CR was complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented, PR was decrease in tumor burden \\>= 50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation and SD defined as not meeting criteria for CR and PR, in absence of Progressive Disease (increase in tumor burden \\>= 25 % relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The participants with baseline and follow up radiographic assessments were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '430'}, {'groupId': 'FG001', 'numSubjects': '213'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '411'}, {'groupId': 'FG001', 'numSubjects': '200'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '430'}, {'groupId': 'FG001', 'numSubjects': '213'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '299'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Protocol Terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Randomized But Never Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}], 'preAssignmentDetails': 'Total 643 participants were screened and enrolled in the study. Out of them, only 611 participants have received the study drug and participated in the study while 32 participants never received any study drug.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '411', 'groupId': 'BG000'}, {'value': '200', 'groupId': 'BG001'}, {'value': '611', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Xilonix', 'description': 'Participants received 7.5 milligram per kilogram (mg/kg) Xilonix (MABp1) via intravenous (IV) injection once every 2 weeks until evidence of radiographic or clinical progression along with best supportive care (BSC) (up to 18 months).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants received placebo via IV injection once every 2 weeks until evidence of radiographic or clinical progression plus BSC (up to 18 months).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '10.14', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '9.98', 'groupId': 'BG001'}, {'value': '62.3', 'spread': '10.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '159', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '253', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '252', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', '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': '15', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '355', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '541', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Australia', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'England', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'USA', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '199', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age (years)', 'classes': [{'title': '< 65 years', 'categories': [{'measurements': [{'value': '229', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}]}, {'title': 'Between 65 and 75 years', 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '205', 'groupId': 'BG002'}]}]}, {'title': '> 75 years', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline analysis population included all participants who were randomized and received at least one infusion of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-05', 'size': 2807804, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-04-22T16:20', 'hasProtocol': True}, {'date': '2017-08-18', 'size': 2288958, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-04-22T16:20', 'hasProtocol': False}]}}, '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': 643}}, 'statusModule': {'whyStopped': 'The study crossed the prospective futility boundary of primary endpoint', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-28', 'studyFirstSubmitDate': '2013-01-08', 'resultsFirstSubmitDate': '2021-04-22', 'studyFirstSubmitQcDate': '2013-01-10', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-06-28', 'studyFirstPostDateStruct': {'date': '2013-01-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 18 months', 'description': 'Overall survival time was defined as the duration from the date of randomization until death or last follow-up. OS was summarized by Kaplan-Meier method and compared between the treatment groups using un-adjusted log-rank test.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Lean Body Mass (LBM) Measured by Dual-energy X-ray Absorptiometry (DEXA) Scans', 'timeFrame': 'Baseline and Week 8', 'description': 'Change from baseline in LBM as measured by Dexa scans was reported. DEXA is an X-ray imaging modality used to determine the mass of one material in the presence of another material, using the knowledge of their unique X-ray attenuation at different energies.'}, {'measure': 'Change From Baseline in Symptom Scale and Global Health Status/Quality of Life (QoL) Assessed Through the Cancer-specific European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)', 'timeFrame': 'Baseline and Week 8', 'description': 'The EORTC QLQ-C30 questionnaire incorporates nine multi-item scales: 5 functional scales (physical, cognitive, role, emotional, and social); 3 symptom scales (pain, fatigue, and appetite loss) and a Global Health Status/QoL scale. Each item, except Global Health Status, is answered on a four-point scale (1-4): 1-not at all, 2-a little, 3-quite a bit, 4-very much. Response to Global Health Status is measured on a 1 to 7 scale. "1" being very poor and "7" being excellent. Each scale (symptom scale \\[pain, fatigue, and appetite loss\\] and Global Health Status/Quality of Life \\[QoL\\] scale) was linearly transformed to be in range from 0-100 where a higher score represents good health status, while lower scores indicate poor health status. As planned, the data for symptom scales (pain, fatigue, appetite loss) and a Global Health Status/QoL scale was evaluated and reported.'}, {'measure': 'Change From Baseline in Platelet Counts', 'timeFrame': 'Baseline and Week 8', 'description': 'Change from baseline in platelet counts up to Week 8 was evaluated.'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 18 Months', 'description': 'PFS was defined as time from randomization to tumor progression or death. Progressive Disease defined as increase in tumor burden greater than or equals to (\\>=) 25 (%) percent relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented. Participants surviving without disease progression at end of study were censored. PFS was compared by Kaplan-Meier method using log-rank test.'}, {'measure': 'Percentage of Participants With Objective Response (OR)', 'timeFrame': 'Up to 18 months', 'description': 'The percentage of OR was estimated by dividing the total number of confirmed complete response (CR) and partial response (PR) by the total number of participants randomized where CR was complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented and PR was decrease in tumor burden \\>= 50 % relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation.'}, {'measure': 'Percentage of Participants With Disease Control', 'timeFrame': 'Up to 18 months', 'description': 'Percentage of participants who achieved disease control was estimated by dividing the total number of confirmed CRs, PRs and stable disease (SD) by the total number of participants randomized where CR was complete disappearance of all lesions (whether measurable or not, and no new lesions); confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented, PR was decrease in tumor burden \\>= 50% relative to baseline confirmed by a consecutive assessment at least 4 weeks after first documentation and SD defined as not meeting criteria for CR and PR, in absence of Progressive Disease (increase in tumor burden \\>= 25 % relative to nadir (minimum recorded tumor burden) confirmation by a repeat, consecutive assessment no less than 4 weeks from the date first documented).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pivotal', 'Colorectal', 'Survival', 'Phase 3'], 'conditions': ['Metastatic Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '24746841', 'type': 'BACKGROUND', 'citation': 'Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. MABp1, a first-in-class true human antibody targeting interleukin-1alpha in refractory cancers: an open-label, phase 1 dose-escalation and expansion study. Lancet Oncol. 2014 May;15(6):656-66. doi: 10.1016/S1470-2045(14)70155-X. Epub 2014 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if the True Human Monoclonal antibody Xilonix (MABp1) can prolong the life of colorectal carcinoma patients that are refractory to standard therapy.', 'detailedDescription': 'In the setting of refractory, metastatic disease a complete resolution of tumor burden is not a reasonable expectation. Instead, the primary goal of anti-tumor therapy at this stage is to eliminate or reduce the symptomatic effects of the tumor, while trying to prolong survival for as long as possible. Due to treatment related morbidity however, few treatment modalities are ideal for this objective. Even with the most recent targeted agents (such as multi-kinase inhibitors), drug related toxicities frequently lead to relatively short treatment durations. With discontinuation of therapy, disease progression is uncontrolled and prognosis is poor.\n\nNew agents that control disease progression-while improving tumor-related symptoms, rather than causing significant therapy related morbidity-are vitally needed to treat patients with advanced cancer, including those with colorectal cancer. An approach has been taken to develop such an agent using a monoclonal antibody to block the chronic inflammation involved in both malignant disease progression and constitutional symptoms.\n\nXilonix™ is expected to inhibit tumor growth and metastasis by interrupting crucial signals that drive angiogenesis and invasiveness. The antibody therapy may also block tumor microenvironment infiltration by leukocytes (such as myeloid suppressor cells) that suppress antitumor immunity, enabling better host immune control of the disease. In addition to local effects on the tumor, Xilonix™ is expected to work systemically to correct the metabolic dysregulation, fatigue and anxiety mediated by chronic inflammatory signaling to the central nervous system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with standard approved regimens including, oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype.\n2. Subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.\n4. At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics.\n5. Age ≥ 18 years, male or female subjects.\n6. Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal.\n7. Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN.\n8. Adequate hepatic function\n9. Adequate bone marrow function\n10. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.\n11. Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.\n12. Patients enrolled must, in the Investigator's judgment, be healthy enough to stay on the clinical trial for three months.\n\nExclusion Criteria:\n\n1. Mechanical obstruction that would prevent adequate oral nutritional intake.\n2. Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.\n3. Uncontrolled or significant cardiovascular disease, including:\n4. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.\n5. Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1; excluding alopecia and grade 2 neuropathy.\n6. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).\n7. Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of hepatitis C RNA.\n8. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).\n9. Receipt of a live (attenuated) vaccine within 1 month prior to Screening\n10. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition of XILONIX™.\n11. Women who are pregnant or breastfeeding.\n12. WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication.\n13. Weight loss \\>20% in the previous 6 months."}, 'identificationModule': {'nctId': 'NCT01767857', 'acronym': 'XCITE', 'briefTitle': 'A Phase III Study of Xilonix in Patients With Advanced Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': '2012-PT023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Xilonix', 'description': 'MABp1 administered IV every two weeks, plus best supportive care', 'interventionNames': ['Drug: Xilonix']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered IV every two weeks, plus best supportive care', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Xilonix', 'type': 'DRUG', 'otherNames': ['MABp1, CA-18C3'], 'description': 'Xilonix is a True Human Monoclonal Antibody targeting Interleukin 1 alpha, and is administered intravenously every 2 weeks with best supportive care until clinical or radiographic progression.', 'armGroupLabels': ['Xilonix']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Oncology, Bruno Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Southern Cancer Center, PC', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35661', 'city': 'Muscle Shoals', 'state': 'Alabama', 'country': 'United States', 'facility': 'Northwest Alabama Cancer Center, PC', 'geoPoint': {'lat': 34.74481, 'lon': -87.66753}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Oncology Associates', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Cancer Medical Center, Inc.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Associates for Research and Excellence, Inc. (cCARE)', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Medical Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC Norris Comprehensive Cancer Center and LAC USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '93030', 'city': 'Oxnard', 'state': 'California', 'country': 'United States', 'facility': 'Ventura County Hematology-Oncology Specialists', 'geoPoint': {'lat': 34.1975, 'lon': -119.17705}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Institute', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '90603', 'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'American Institute of Research', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Medical Specialists', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '31792', 'city': 'Thomasville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Lewis Hall Singletary Oncology Center', 'geoPoint': {'lat': 30.83658, 'lon': -83.97878}}, {'zip': '60625', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Swedish Covenant Hospital via Clintell, Inc.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60426', 'city': 'Harvey', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ingalls Memorial Hospital', 'geoPoint': {'lat': 41.61003, 'lon': -87.64671}}, {'zip': '60141', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Hines VA Hospital', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Oncology Specialists, SC', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Franciscan St. Francis Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '67502', 'city': 'Hutchinson', 'state': 'Kansas', 'country': 'United States', 'facility': 'Hutchinson Clinic, P.A.', 'geoPoint': {'lat': 38.06084, 'lon': -97.92977}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'James Graham Brown Cancer Center', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Cancer and Blood Disorders, a Division of Regional Cancer Care Associates LLC.', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55416', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Park Nicollet', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11733', 'city': 'East Setauket', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Hematology Oncology Associates, PC', 'geoPoint': {'lat': 40.94149, 'lon': -73.10594}}, {'zip': '10549', 'city': 'Mount Kisco', 'state': 'New York', 'country': 'United States', 'facility': 'Northern Westchester Hospital', 'geoPoint': {'lat': 41.20426, 'lon': -73.72708}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook Cancer Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '27889', 'city': 'Washington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina Health - Beaufort, Inc. 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