Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT01336205
Status:
COMPLETED
Last Update Posted:
2014-10-20
First Post:
2011-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000079689', 'term': 'Opioid-Induced Constipation'}], 'ancestors': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000589308', 'term': 'naloxegol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aztrial_results_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'NKTR-118 25 mg', 'otherNumAtRisk': 534, 'otherNumAffected': 365, 'seriousNumAtRisk': 534, 'seriousNumAffected': 51}, {'id': 'EG001', 'title': 'Usual Care', 'otherNumAtRisk': 270, 'otherNumAffected': 152, 'seriousNumAtRisk': 270, 'seriousNumAffected': 30}], 'otherEvents': [{'term': 'ABDOMINAL DISCOMFORT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 98, 'numAffected': 98}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ABDOMINAL PAIN UPPER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 73, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'FLATULENCE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 39, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'GASTROOESOPHAGEAL REFLUX DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'NAUSEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 56, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CHILLS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'FATIGUE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'OEDEMA PERIPHERAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PYREXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'INFLUENZA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'NASOPHARYNGITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 33, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'UPPER RESPIRATORY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'URINARY TRACT INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 24, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPERCHOLESTEROLAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ARTHRALGIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 48, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MUSCLE SPASMS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DIZZINESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HEADACHE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 48, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ANXIETY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'INSOMNIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'COUGH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 27, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'NASAL CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPERHIDROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPERTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ATRIAL FIBRILLATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CARDIAC FAILURE CONGESTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MYOCARDIAL ISCHAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'THYROID MASS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'COLITIS ISCHAEMIC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PANCREATITIS ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RECTAL HAEMORRHAGE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SMALL INTESTINAL OBSTRUCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ASTHENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DEATH', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'NON-CARDIAC CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CHOLECYSTITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CHOLELITHIASIS OBSTRUCTIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DRUG HYPERSENSITIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CELLULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CELLULITIS GANGRENOUS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'EXTRADURAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'GASTROENTERITIS VIRAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LOBAR PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PYELONEPHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SEPSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'STAPHYLOCOCCAL INFECTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'VULVAL ABSCESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ANKLE FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CONTUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'FALL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'FIBULA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'INTENTIONAL OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LIMB INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'OVERDOSE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'POST PROCEDURAL COMPLICATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RADIUS FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RIB FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'THORACIC VERTEBRAL FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'TIBIA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ULNA FRACTURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BLOOD PRESSURE DECREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BLOOD PRESSURE INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'TRANSAMINASES INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'TROPONIN INCREASED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPERKALAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPOGLYCAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BACK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'FLANK PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LUMBAR SPINAL STENOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MUSCULOSKELETAL CHEST PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MUSCULOSKELETAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'OSTEOARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'OSTEONECROSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PAIN IN EXTREMITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RHABDOMYOLYSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RHEUMATOID ARTHRITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ROTATOR CUFF SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BREAST CANCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LUNG ADENOCARCINOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'LYMPHOMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SUPERFICIAL SPREADING MELANOMA STAGE II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'THYROID CANCER RECURRENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'AKATHISIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ALTERED STATE OF CONSCIOUSNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CEREBROVASCULAR ACCIDENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CERVICAL NEURITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CERVICOBRACHIAL SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'COMPLICATED MIGRAINE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPOGLYCAEMIC COMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'IDIOPATHIC GENERALISED EPILEPSY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ISCHAEMIC CEREBRAL INFARCTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RADICULITIS CERVICAL', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SYNCOPE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'BIPOLAR I DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HOMICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'MAJOR DEPRESSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PANIC ATTACK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PSYCHOTIC DISORDER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SCHIZOPHRENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SUICIDAL IDEATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SUICIDE ATTEMPT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RENAL FAILURE ACUTE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'RENAL INJURY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ENDOMETRIAL HYPERPLASIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'PULMONARY CONGESTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'SKIN DISCOLOURATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'HYPOVOLAEMIC SHOCK', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'ORTHOSTATIC HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 534, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 270, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Patients Experiencing at Least One Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-118 25 mg', 'description': 'NKTR-118 25 mg QD, oral treatment'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.'}], 'classes': [{'categories': [{'measurements': [{'value': '437', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) to end of the follow-up period', 'description': 'The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.'}, {'type': 'PRIMARY', 'title': 'Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-118 25 mg', 'description': 'NKTR-118 25 mg QD, oral treatment'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Patients in the Usual Care group were not taking any IP and thus could not be categorized for this parameter.', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) to end of the follow-up period', 'description': 'The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.'}, {'type': 'PRIMARY', 'title': 'Incidence of Patients Experiencing Severe Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NKTR-118 25 mg', 'description': 'NKTR-118 25 mg QD, oral treatment'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.'}], 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Week 0) to end of the follow-up period', 'description': 'The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety analysis set included all randomized patients who received at least 1 dose of IP and patients who received Usual Care, with the exception of patients who were randomized multiple times within the program at different centers or patients who were randomized at sites where data integrity issues were identified.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NKTR-118 25 mg', 'description': 'NKTR-118 25 mg QD, oral treatment'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '563'}, {'groupId': 'FG001', 'numSubjects': '281'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '330'}, {'groupId': 'FG001', 'numSubjects': '192'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}, {'groupId': 'FG001', 'numSubjects': '89'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'Study-Specific Withdrawal Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Severe noncompliance with protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '56'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Eligibility Criteria Not Fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '72'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'Did not receive treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This multicenter study was conducted in the United States between 18 April 2011 and 03 December 2012.', 'preAssignmentDetails': "The study duration was 54 to 58 weeks. New patients underwent an initial screening period lasting up to 2 weeks and a 2-week OIC confirmation period. New patients and patients enrolling from another study (also referred to as 'roll over patients') entered the 52-week treatment period, followed by a 2 week follow-up period."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'BG000'}, {'value': '270', 'groupId': 'BG001'}, {'value': '804', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NKTR-118 25 mg', 'description': 'NKTR-118 25 mg QD, oral treatment'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'spread': '10.09', 'groupId': 'BG000'}, {'value': '52.7', 'spread': '10.24', 'groupId': 'BG001'}, {'value': '52.7', 'spread': '10.13', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '353', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '532', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '181', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '272', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '423', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '627', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 36 patients (11 patients in the Usual Care group and 25 new patients in the NKTR-118 25 mg group) had either: a) previously or concurrently participated in the NKTR-118 program at another study center; or b) were randomized at sites where data integrity issues were identified. These patients were excluded from the Safety analysis set.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 844}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-13', 'studyFirstSubmitDate': '2011-04-14', 'resultsFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2011-04-14', 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-10-13', 'studyFirstPostDateStruct': {'date': '2011-04-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Patients Experiencing at Least One Adverse Event (AE)', 'timeFrame': 'Baseline (Week 0) to end of the follow-up period', 'description': 'The incidence of patients experiencing at least one AE during the randomized treatment and follow-up periods was calculated.'}, {'measure': 'Incidence of Patients Experiencing AEs That Resulted in Discontinuation of Investigational Product (IP)', 'timeFrame': 'Baseline (Week 0) to end of the follow-up period', 'description': 'The incidence of patients experiencing AEs that resulted in discontinuation of IP during the randomized treatment or follow-up periods was calculated.'}, {'measure': 'Incidence of Patients Experiencing Severe Adverse Events (SAEs)', 'timeFrame': 'Baseline (Week 0) to end of the follow-up period', 'description': 'The incidence of patients experiencing SAEs during the randomized treatment and follow-up periods was calculated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-Cancer-Related Pain', 'Opioid-Induced Constipation'], 'conditions': ['Opioid-Induced Constipation (OIC)']}, 'referencesModule': {'references': [{'pmid': '25112584', 'type': 'DERIVED', 'citation': 'Webster L, Chey WD, Tack J, Lappalainen J, Diva U, Sostek M. Randomised clinical trial: the long-term safety and tolerability of naloxegol in patients with pain and opioid-induced constipation. Aliment Pharmacol Ther. 2014 Oct;40(7):771-9. doi: 10.1111/apt.12899. Epub 2014 Aug 12.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1390&filename=Clinical_Study_Report_Synopsis_D3820C00008.pdf', 'label': 'Clinical\\_Study\\_Report\\_Synopsis\\_D3820C00008'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118 treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of written informed consent prior to any study-specific procedures.\n* NEW PATIENTS ONLY: Self-reported active symptoms of OIC at screening (\\<3 SBMs/week and experiencing \\>1 reported symptom of hard/lumpy stools, straining, or sensation of incomplete evacuation/anorectal obstruction in at least 25% of the BMs over the previous 4 weeks); and Documented confirmed OIC (\\<3 SBMs/week on average over the 2-week OIC confirmation period.\n* PATIENTS ENROLLING FROM OTHER NKTR-118 STUDIES: Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30 mg to 1000 mg or oral morphine, or equianalgesic amount(s) of 1 or more opioid therapies.\n* FOR PATIENTS RANDOMIZED TO RECEIVE NKTR-118: Willingness to stop all laxatives and other bowel regimens including prune juice and herbal products throughout the 52-week treatment period, and to use only bisacodyl as rescue medication if BM has not occurred within at least 72 hours of the last recorded BM.\n\nExclusion Criteria:\n\n* Patients receiving Opioid regimen for treatment of pain related to cancer.\n* History of cancer within 5 years from first study visit with the exception of basal cell cancer and squamous cell skin cancer.\n* Medical conditions and treatments associated with diarrhea, intermittent loose stools, or constipation.\n* Other issues related to the gastrointestinal tract that could impose a risk to the patient.\n* Pregnancy or lactation.'}, 'identificationModule': {'nctId': 'NCT01336205', 'briefTitle': 'Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-Label 52-week Study to Assess the Long-Term Safety of NKTR-118 in Opioid-Induced Constipation (OIC) in Patients With Non-Cancer-Related Pain', 'orgStudyIdInfo': {'id': 'D3820C00008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Oral Treatment', 'interventionNames': ['Drug: NKTR-118']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Oral treatment', 'interventionNames': ['Drug: Usual care']}], 'interventions': [{'name': 'NKTR-118', 'type': 'DRUG', 'description': '25 mg oral tablet once daily', 'armGroupLabels': ['1']}, {'name': 'Usual care', 'type': 'DRUG', 'description': 'As prescribed by the investigator', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.80243, 'lon': -86.97219}}, {'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'city': 'Pell City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.58621, 'lon': -86.28609}}, {'city': 'Garden Grove', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.43532, 'lon': -112.35821}}, {'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'Tuscon', 'state': 'Arizona', 'country': 'United States', 'facility': 'Research Site'}, {'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'city': 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'Research Site', 'geoPoint': {'lat': 33.74557, 'lon': -117.86783}}, {'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Whittier', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.97918, 'lon': -118.03284}}, {'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'city': 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