Viewing Study NCT02367820

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
Ignite Creation Date: 2025-12-25 @ 4:10 AM
Ignite Modification Date: 2026-02-24 @ 2:42 PM
Study NCT ID: NCT02367820
Status: COMPLETED
Last Update Posted: 2021-06-22
First Post: 2015-02-09
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'StudyInquiry@nektar.com', 'phone': '855-482-8676', 'title': 'Medical Affairs', 'organization': 'Nektar Therapeutics'}, 'certainAgreement': {'otherDetails': 'If a joint manuscript has not been submitted for publication within twelve (12) months of completion or termination of the study, the PI is free to publish separately, upon provision of any proposed publication or manuscript to the Sponsor at least sixty (60) days before it is submitted or otherwise disclosed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were reported starting immediately after the subject provided written informed consent through the end of study, which was approximately 57-weeks in length for each subject.', 'description': "Adverse events were collected after the subject provided written informed consent through the end of study. Adverse event data were obtained via spontaneous reports or per direct questioning or observation during protocol-mandated study assessments. All ongoing AEs were followed until resolution or for 14 days after the subject's last visit, whichever came first. All SAEs were followed until resolution, stabilization of condition, return to baseline, or until follow-up was no longer possible.", 'eventGroups': [{'id': 'EG000', 'title': 'Rollover NKTR-181', 'description': 'Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 136, 'seriousNumAtRisk': 214, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG001', 'title': 'Rollover PBO', 'description': 'Subjects administered placebo in preceding phase 3 efficacy/safety study', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 151, 'seriousNumAtRisk': 217, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'De Novo Opioid Experienced', 'description': 'Newly enrolled opioid experienced subjects', 'otherNumAtRisk': 134, 'deathsNumAtRisk': 134, 'otherNumAffected': 110, 'seriousNumAtRisk': 134, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': 'De Novo Naive', 'description': 'Newly enrolled opioid naïve subjects', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 62, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 28, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 41, 'numAffected': 41}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 56, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 41, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Drug withdrawal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 21, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Goitre', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Generalized Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Hisoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Follicular thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebral Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Renal Mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Uterine Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Decubitus Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 134, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Reporting Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '217', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rollover NKTR-181', 'description': 'Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study'}, {'id': 'OG001', 'title': 'Rollover PBO', 'description': 'Subjects administered placebo in preceding phase 3 efficacy/safety study'}, {'id': 'OG002', 'title': 'De Novo Opioid Experienced', 'description': 'Newly enrolled opioid experienced subjects'}, {'id': 'OG003', 'title': 'De Novo Naive', 'description': 'Newly enrolled opioid naïve subjects'}], 'classes': [{'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening baseline through end of study, an average of 57 weeks', 'description': 'Count of subjects reporting treatment emergent adverse events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rollover NKTR-181', 'description': 'Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study'}, {'id': 'OG001', 'title': 'Rollover PBO', 'description': 'Subjects administered placebo in preceding phase 3 efficacy/safety study'}, {'id': 'OG002', 'title': 'De Novo Opioid Experienced', 'description': 'Newly enrolled opioid experienced subjects'}, {'id': 'OG003', 'title': 'De Novo Naive', 'description': 'Newly enrolled opioid naïve subjects'}], 'classes': [{'title': 'Pain Intensity: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.57', 'spread': '1.968', 'groupId': 'OG000'}, {'value': '4.11', 'spread': '2.112', 'groupId': 'OG001'}, {'value': '5.91', 'spread': '1.749', 'groupId': 'OG002'}, {'value': '6.18', 'spread': '1.459', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.22', 'spread': '2.109', 'groupId': 'OG000'}, {'value': '-1.71', 'spread': '2.212', 'groupId': 'OG001'}, {'value': '-2.19', 'spread': '2.009', 'groupId': 'OG002'}, {'value': '-2.66', 'spread': '1.808', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.02', 'spread': '2.233', 'groupId': 'OG000'}, {'value': '-1.40', 'spread': '2.314', 'groupId': 'OG001'}, {'value': '-2.26', 'spread': '2.134', 'groupId': 'OG002'}, {'value': '-2.26', 'spread': '2.068', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '2.037', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '2.172', 'groupId': 'OG001'}, {'value': '-2.01', 'spread': '2.000', 'groupId': 'OG002'}, {'value': '-2.49', 'spread': '1.966', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '2.142', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '2.278', 'groupId': 'OG001'}, {'value': '-2.06', 'spread': '1.932', 'groupId': 'OG002'}, {'value': '-2.38', 'spread': '2.115', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.24', 'spread': '2.269', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '2.267', 'groupId': 'OG001'}, {'value': '-2.04', 'spread': '1.933', 'groupId': 'OG002'}, {'value': '-2.58', 'spread': '1.874', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '2.116', 'groupId': 'OG000'}, {'value': '-1.54', 'spread': '2.319', 'groupId': 'OG001'}, {'value': '-2.09', 'spread': '2.016', 'groupId': 'OG002'}, {'value': '-2.44', 'spread': '2.323', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.37', 'spread': '2.103', 'groupId': 'OG000'}, {'value': '-1.49', 'spread': '2.425', 'groupId': 'OG001'}, {'value': '-1.87', 'spread': '2.053', 'groupId': 'OG002'}, {'value': '-2.80', 'spread': '2.173', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '2.131', 'groupId': 'OG000'}, {'value': '-1.58', 'spread': '2.220', 'groupId': 'OG001'}, {'value': '-2.06', 'spread': '1.944', 'groupId': 'OG002'}, {'value': '-3.01', 'spread': '2.258', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.15', 'spread': '1.837', 'groupId': 'OG000'}, {'value': '-1.82', 'spread': '2.190', 'groupId': 'OG001'}, {'value': '-2.21', 'spread': '1.908', 'groupId': 'OG002'}, {'value': '-2.84', 'spread': '2.289', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.45', 'spread': '2.154', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '2.366', 'groupId': 'OG001'}, {'value': '-1.83', 'spread': '1.915', 'groupId': 'OG002'}, {'value': '-2.65', 'spread': '1.933', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'spread': '2.149', 'groupId': 'OG000'}, {'value': '-1.48', 'spread': '2.303', 'groupId': 'OG001'}, {'value': '-2.08', 'spread': '2.144', 'groupId': 'OG002'}, {'value': '-2.31', 'spread': '2.043', 'groupId': 'OG003'}]}]}, {'title': 'Pain Intensity: Change from Baseline to Day 364', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.78', 'spread': '2.175', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '2.520', 'groupId': 'OG001'}, {'value': '-1.20', 'spread': '2.102', 'groupId': 'OG002'}, {'value': '-2.15', 'spread': '2.055', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, monthly change from baseline till the end of study', 'description': 'A self-reported scale measuring severity of pain on function. The mean of the 4 intensity items (3-6) is calculated and used as a measure of pain severity. If there were missing items when the pain severity score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain intensity and interference for each question is from 0 to 10. The range of possible scores is from 0 to 70. Higher score indicates relatively worse pain severity and greater interference that pain causes in day to day activities.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set is defined as all enrolled subjects who received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Rollover NKTR-181', 'description': 'Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study'}, {'id': 'OG001', 'title': 'Rollover PBO', 'description': 'Subjects administered placebo in preceding phase 3 efficacy/safety study'}, {'id': 'OG002', 'title': 'De Novo Opioid Experienced', 'description': 'Newly enrolled opioid experienced subjects'}, {'id': 'OG003', 'title': 'De Novo Naive', 'description': 'Newly enrolled opioid naïve subjects'}], 'classes': [{'title': 'Pain Interference: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '188', 'groupId': 'OG001'}, {'value': '129', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.91', 'spread': '2.205', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '2.281', 'groupId': 'OG001'}, {'value': '5.41', 'spread': '2.298', 'groupId': 'OG002'}, {'value': '5.44', 'spread': '1.957', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.23', 'spread': '2.301', 'groupId': 'OG000'}, {'value': '-1.52', 'spread': '2.163', 'groupId': 'OG001'}, {'value': '-2.34', 'spread': '2.175', 'groupId': 'OG002'}, {'value': '-2.71', 'spread': '2.169', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.07', 'spread': '2.070', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '2.340', 'groupId': 'OG001'}, {'value': '-2.51', 'spread': '2.583', 'groupId': 'OG002'}, {'value': '-2.17', 'spread': '2.679', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '161', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.17', 'spread': '2.070', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '2.104', 'groupId': 'OG001'}, {'value': '-2.18', 'spread': '2.350', 'groupId': 'OG002'}, {'value': '-2.38', 'spread': '2.277', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.24', 'spread': '2.344', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '2.222', 'groupId': 'OG001'}, {'value': '-2.15', 'spread': '2.447', 'groupId': 'OG002'}, {'value': '-2.11', 'spread': '2.179', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '2.389', 'groupId': 'OG000'}, {'value': '-1.36', 'spread': '2.309', 'groupId': 'OG001'}, {'value': '-2.33', 'spread': '2.299', 'groupId': 'OG002'}, {'value': '-2.48', 'spread': '2.173', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 150', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.12', 'spread': '2.329', 'groupId': 'OG000'}, {'value': '-1.22', 'spread': '2.500', 'groupId': 'OG001'}, {'value': '-2.26', 'spread': '2.372', 'groupId': 'OG002'}, {'value': '-2.16', 'spread': '2.290', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 180', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.31', 'spread': '2.247', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '2.507', 'groupId': 'OG001'}, {'value': '-2.09', 'spread': '2.551', 'groupId': 'OG002'}, {'value': '-2.27', 'spread': '2.404', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 210', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.95', 'spread': '2.325', 'groupId': 'OG000'}, {'value': '-1.29', 'spread': '2.215', 'groupId': 'OG001'}, {'value': '-2.43', 'spread': '2.365', 'groupId': 'OG002'}, {'value': '-2.38', 'spread': '2.611', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 240', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '64', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.95', 'spread': '2.119', 'groupId': 'OG000'}, {'value': '-1.55', 'spread': '2.197', 'groupId': 'OG001'}, {'value': '-2.49', 'spread': '2.503', 'groupId': 'OG002'}, {'value': '-2.27', 'spread': '2.240', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 270', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.21', 'spread': '2.339', 'groupId': 'OG000'}, {'value': '-1.37', 'spread': '2.329', 'groupId': 'OG001'}, {'value': '-2.02', 'spread': '2.374', 'groupId': 'OG002'}, {'value': '-2.01', 'spread': '2.193', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 300', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.90', 'spread': '2.307', 'groupId': 'OG000'}, {'value': '-1.38', 'spread': '2.137', 'groupId': 'OG001'}, {'value': '-2.07', 'spread': '2.280', 'groupId': 'OG002'}, {'value': '-1.94', 'spread': '2.357', 'groupId': 'OG003'}]}]}, {'title': 'Pain Interference: Change from Baseline to Day 364', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.69', 'spread': '2.258', 'groupId': 'OG000'}, {'value': '-1.14', 'spread': '2.493', 'groupId': 'OG001'}, {'value': '-1.33', 'spread': '2.396', 'groupId': 'OG002'}, {'value': '-2.08', 'spread': '2.504', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, monthly change from baseline till the end of study', 'description': 'A self-reported scale measuring interference of pain on function. The mean of the 7 interference items was calculated and used as a measure of Pain interference. If there were missing items when the pain interference score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain interference is from 0 to 10. Higher score indicates relatively worse pain problem.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set is defined as all enrolled subjects who received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NKTR-181', 'description': 'NKTR-181 tablets at 100-600 mg orally twice daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '638'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '402'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '236'}]}]}], 'recruitmentDetails': 'First subject screened 14 April 2015. Last subject out: 24 January 2018. The study was conducted at 55 medical/research centers in the United States.', 'preAssignmentDetails': 'The titration phase of the study was designed to titrate patients to a dose of NKTR-181 that provided adequate analgesia and acceptable side effects.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '217', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '638', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Rollover NKTR-181', 'description': 'Subjects administered NKTR-181 in preceding phase 3 efficacy/safety study'}, {'id': 'BG001', 'title': 'Rollover PBO', 'description': 'Subjects administered placebo in preceding phase 3 efficacy/safety study'}, {'id': 'BG002', 'title': 'De Novo Naive', 'description': 'Newly enrolled opioid naïve subjects'}, {'id': 'BG003', 'title': 'De Novo Opioid Experienced', 'description': 'Newly enrolled opioid experienced subjects'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51.7', 'spread': '12.01', 'groupId': 'BG000'}, {'value': '51.4', 'spread': '12.31', 'groupId': 'BG001'}, {'value': '51.9', 'spread': '10.44', 'groupId': 'BG002'}, {'value': '55.6', 'spread': '11.12', 'groupId': 'BG003'}, {'value': '52.4', 'spread': '11.85', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '123', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '375', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '52', 'groupId': 'BG003'}, {'value': '263', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '184', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '136', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '431', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Analysis Set is defined as all enrolled subjects who received at least 1 dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-15', 'size': 404481, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-14T18:49', 'hasProtocol': True}, {'date': '2017-10-03', 'size': 1529873, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-14T18:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 638}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'dispFirstSubmitDate': '2018-03-02', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-15', 'studyFirstSubmitDate': '2015-02-09', 'dispFirstSubmitQcDate': '2018-03-02', 'resultsFirstSubmitDate': '2020-06-22', 'studyFirstSubmitQcDate': '2015-02-13', 'dispFirstPostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-14', 'studyFirstPostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Adverse Events', 'timeFrame': 'Screening baseline through end of study, an average of 57 weeks', 'description': 'Count of subjects reporting treatment emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Brief Pain Inventory (BPI) Pain Intensity Item to Week 52', 'timeFrame': 'Baseline, monthly change from baseline till the end of study', 'description': 'A self-reported scale measuring severity of pain on function. The mean of the 4 intensity items (3-6) is calculated and used as a measure of pain severity. If there were missing items when the pain severity score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain intensity and interference for each question is from 0 to 10. The range of possible scores is from 0 to 70. Higher score indicates relatively worse pain severity and greater interference that pain causes in day to day activities.'}, {'measure': 'Change From Baseline in Brief Pain Inventory (BPI) Pain Interference Item to Week 52', 'timeFrame': 'Baseline, monthly change from baseline till the end of study', 'description': 'A self-reported scale measuring interference of pain on function. The mean of the 7 interference items was calculated and used as a measure of Pain interference. If there were missing items when the pain interference score was calculated, the mean of the completed items in one dimension (dimensions include pain severity and pain interference) were imputed to substitute the missing item, provided that more than 50% of the items in one dimension were completed (Halling, 1999). The range of pain interference is from 0 to 10. Higher score indicates relatively worse pain problem.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Low Back Pain', 'Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '31361019', 'type': 'BACKGROUND', 'citation': 'Gudin J, Rauck R, Argoff C, Agaiby E, Gimbel J, Katz N, Doberstein SK, Tagliaferri M, Tagliaferri M, Potts J, Wild J, Lu L, Siddhanti S, Hale M, Markman J. Long-term Safety and Tolerability of NKTR-181 in Patients with Moderate to Severe Chronic Low Back Pain or Chronic Noncancer Pain: A Phase 3 Multicenter, Open-Label, 52-Week Study (SUMMIT-08 LTS). Pain Med. 2020 Nov 7;21(7):1347-1356. doi: 10.1093/pm/pnz169.'}, {'pmid': '30957581', 'type': 'DERIVED', 'citation': 'Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this 52-week open label study is to determine the long-term safety of a new opioid molecule, NKTR-181, in patients with moderate to severe chronic low back pain or chronic non-cancer pain.', 'detailedDescription': 'This is an open-label safety and tolerability study in which approximately 600 subjects will receive NKTR-181 for up to 52 weeks. Subjects may include newly enrolled subjects and subjects who have recently completed SUMMIT-07 study.\n\nThis study will also investigate the pharmacokinetics of NKTR-181 in patients with chronic low back pain or chronic non-cancer pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or non-pregnant, non-nursing female aged 18 to 75 years old\n* Clinical diagnosis of moderate to severe, chronic low back or non-cancer pain for at least three months\n* Not experiencing adequate pain relief or have failed previous treatment with non-opioid analgesics\n* Opioid analgesia is necessary\n* Currently taking no less than 10 mg but no more than 60 mg of morphine sulfate equivalents (MSE) per day of opioid analgesics for at least 7 days prior to entry\n* Females of child bearing potential must be using a highly effective form of birth control. All subjects must agree to use double-barrier contraception during participation in this study and for at least 2 months after the last dose of the study drug.\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* History of hypersensitivity, intolerance, or allergy to opioids\n* Surgical procedures in the last 4 weeks or plans to undergo surgical procedures during the study period\n* Untreated moderate to severe sleep apnea\n* Chronic migraines as the primary pain condition\n* Cancer related pain'}, 'identificationModule': {'nctId': 'NCT02367820', 'acronym': 'SUMMIT-LTS', 'briefTitle': 'Long-Term Safety and Tolerability Study of NKTR-181 in Subjects With Chronic Low Back Pain or Chronic Non-Cancer Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nektar Therapeutics'}, 'officialTitle': 'A Phase 3 Multicenter, Open-Label, 52-Week Study To Evaluate the Long-Term Safety and Tolerability of NKTR-181 in Subjects With Moderate to Severe Chronic Low Back Pain or Chronic Non-Cancer Pain', 'orgStudyIdInfo': {'id': '14-181-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NKTR-181', 'description': 'NKTR-181 twice daily (BID) tablets', 'interventionNames': ['Drug: NKTR-181 BID tablets']}], 'interventions': [{'name': 'NKTR-181 BID tablets', 'type': 'DRUG', 'description': 'NKTR-181 tablets 100-600 mg twice daily (BID)', 'armGroupLabels': ['NKTR-181']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36571', 'city': 'Saraland', 'state': 'Alabama', 'country': 'United States', 'facility': 'Investigator Site - Saraland', 'geoPoint': {'lat': 30.82074, 'lon': -88.07056}}, {'zip': '85023', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site - Phoenix', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Investigator Site - Tempe', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Investigator Site - Little Rock', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Investigator Site - Stamford', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33765', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - Clearwater', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '33312', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - Fort Lauderdale', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - Fort Myers', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32257', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32174', 'city': 'Ormond Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - Ormond Beach', 'geoPoint': {'lat': 29.28581, 'lon': -81.05589}}, {'zip': '33324', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - Plantation', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '33603', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - Tampa', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Investigator Site - West Palm Beach', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '30338', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator Site - Atlanta', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30513', 'city': 'Blue Ridge', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator Site - Blue Ridge', 'geoPoint': {'lat': 34.86397, 'lon': -84.32409}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator Site - Marietta', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '30092', 'city': 'Norcross', 'state': 'Georgia', 'country': 'United States', 'facility': 'Investigator Site - Norcross', 'geoPoint': {'lat': 33.94121, 'lon': -84.21353}}, {'zip': '60031', 'city': 'Gurnee', 'state': 'Illinois', 'country': 'United States', 'facility': 'Investigator Site - Gurnee', 'geoPoint': {'lat': 42.3703, 'lon': -87.90202}}, {'zip': '50265', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Investigator Site - West Des Moines', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '67207', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Investigator Site - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '40213', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Investigator Site - Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71111', 'city': 'Bossier City', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigator Site - Bossier', 'geoPoint': {'lat': 32.51599, 'lon': -93.73212}}, {'zip': '70115', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigator Site - New Orleans', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Investigator Site - Shreveport', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48706', 'city': 'Bay City', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigator Site - Bay City', 'geoPoint': {'lat': 43.59447, 'lon': -83.88886}}, {'zip': '48706', 'city': 'Pinconning', 'state': 'Michigan', 'country': 'United States', 'facility': 'Investigator Site - Pinconning', 'geoPoint': {'lat': 43.85363, 'lon': -83.96499}}, {'zip': '39531', 'city': 'Biloxi', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Investigator Site - Biloxi', 'geoPoint': {'lat': 30.39603, 'lon': -88.88531}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigator Site - Saint Louis 1', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Investigator Site - Saint Louis 2', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68134', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Investigator Site - Omaha', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89102', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigator Site - Las Vegas 2', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Investigator Site - Las Vegas 1', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site - Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '14221', 'city': 'Williamsville', 'state': 'New York', 'country': 'United States', 'facility': 'Investigator Site - Williamsville', 'geoPoint': {'lat': 42.96395, 'lon': -78.73781}}, {'zip': '27410', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site - Greensboro', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Investigator Site - Winston Salem', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Investigator Site - Fargo', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}, {'zip': '45432', 'city': 'Beavercreek', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site - Beavercreek', 'geoPoint': {'lat': 39.70923, 'lon': -84.06327}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site - Cincinnati 1', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45246', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site - Cincinnati 2', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43235', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Investigator Site - Columbus', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '16635', 'city': 'Duncansville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigator Site - Duncansville', 'geoPoint': {'lat': 40.42341, 'lon': -78.4339}}, {'zip': '19046', 'city': 'Jenkintown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Investigator Site - Jenkintown', 'geoPoint': {'lat': 40.09594, 'lon': -75.12517}}, {'zip': '57047', 'city': 'Dakota Dunes', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Investigator Site - Dakota Dunes', 'geoPoint': {'lat': 42.48749, 'lon': -96.48642}}, {'zip': '57702', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Investigator Site - Rapid City', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Investigator Site - Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site - Arlington', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '78731', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site - Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '76543', 'city': 'Killeen', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site - Killeen', 'geoPoint': {'lat': 31.11712, 'lon': -97.7278}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Investigator Site - San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigator Site - Salt Lake City', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'facility': 'Investigator Site - West Jordan', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '23114', 'city': 'Midlothian', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigator Site - Midlothian', 'geoPoint': {'lat': 37.50598, 'lon': -77.64916}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Investigator Site - Norfolk', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '53142', 'city': 'Kenosha', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Investigator Site - Kenosha', 'geoPoint': {'lat': 42.58474, 'lon': -87.82119}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nektar Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}