Ignite Creation Date:
2025-12-24 @ 12:16 PM
Ignite Modification Date:
2026-02-02 @ 8:27 AM
Study NCT ID:
NCT00665561
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2008-04-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prospective Observational Epidemiologic Study of Maraviroc's Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Portugal']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 5 years following enrollment', 'description': 'Same event may appear as adverse event (AE) and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another or 1 participant may have experienced both serious and non-serious event during study. Four participants in the arm "MVC-unexposed group" were not counted under "death" reason of discontinuation, because these deaths were not recorded on participant summary page at the time of "reason of discontinuation" analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.', 'otherNumAtRisk': 1316, 'deathsNumAtRisk': 1316, 'otherNumAffected': 111, 'seriousNumAtRisk': 1316, 'deathsNumAffected': 75, 'seriousNumAffected': 435}, {'id': 'EG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.', 'otherNumAtRisk': 1130, 'deathsNumAtRisk': 1130, 'otherNumAffected': 34, 'seriousNumAtRisk': 1130, 'deathsNumAffected': 79, 'seriousNumAffected': 352}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Anaemia macrocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Anaemia of chronic disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Eosinophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Haemorrhagic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lymphocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Methaemoglobinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Arteriosclerosis coronary artery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 11}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiac valve disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiac ventricular thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiogenic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Congestive cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Left ventricular dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Myocarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Torsade de pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Fanconi syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Sickle cell disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Deafness bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Vertigo positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 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1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lumbar spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective 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v21.1'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Anal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Anal cancer stage 0', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Anal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Anaplastic large cell lymphoma T- and null-cell types', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Bladder neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Brain neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': "Burkitt's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cancer pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cervix carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1130, 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'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Diffuse large B-cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Endometrial cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Fibrous histiocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Gastrointestinal lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Haemangioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': "Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lipoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lymphoproliferative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Malignant melanoma in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Malignant melanoma stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Malignant neoplasm of unknown primary site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Metastases to liver', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Metastases to pleura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Neoplasm prostate', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Ocular neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Oesophageal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Ovarian adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Ovarian germ cell teratoma benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pancreatic carcinoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Papillary cystadenoma lymphomatosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Plasmablastic lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Prostatic adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Rectal adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Rectal neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Renal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Skin cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Small cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Small cell lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Squamous cell carcinoma of the oral cavity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Squamous cell carcinoma of the tongue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Tongue neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Vaginal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Vulval cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Alcoholic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Amputation stump pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Depressed level of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Diabetic hyperglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Diabetic neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Embolic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Encephalitis post varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiac resynchronisation therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cataract operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Colostomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Gastric banding reversal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Hysterectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Immune tolerance induction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Inguinal hernia repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Knee arthroplasty', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Medical device removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Renal transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Valvuloplasty cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Aortic arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Bleeding varicose vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Iliac artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lymphoedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Peripheral artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Peripheral artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Peripheral vascular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Subclavian artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Vascular stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Vasospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Infected neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1316, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1130, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.28', 'groupId': 'OG000', 'lowerLimit': '18.57', 'upperLimit': '26.73'}, {'value': '41.77', 'groupId': 'OG001', 'lowerLimit': '36.09', 'upperLimit': '48.34'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.53', 'ciLowerLimit': '0.42', 'ciUpperLimit': '0.67', 'groupDescription': 'Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude risk ratio (RR) and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.38', 'groupId': 'OG000', 'lowerLimit': '0.10', 'upperLimit': '1.54'}, {'value': '0.46', 'groupId': 'OG001', 'lowerLimit': '0.12', 'upperLimit': '1.86'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.12', 'ciUpperLimit': '5.88', 'groupDescription': 'Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'title': 'All Malignancies', 'categories': [{'measurements': [{'value': '12.87', 'groupId': 'OG000', 'lowerLimit': '10.13', 'upperLimit': '16.35'}, {'value': '13.69', 'groupId': 'OG001', 'lowerLimit': '10.61', 'upperLimit': '17.67'}]}]}, {'title': 'AIDS defining Malignancies', 'categories': [{'measurements': [{'value': '2.31', 'groupId': 'OG000', 'lowerLimit': '1.31', 'upperLimit': '4.06'}, {'value': '3.71', 'groupId': 'OG001', 'lowerLimit': '2.27', 'upperLimit': '6.06'}]}]}, {'title': 'Non-AIDS defining Malignancies', 'categories': [{'measurements': [{'value': '10.56', 'groupId': 'OG000', 'lowerLimit': '8.11', 'upperLimit': '13.76'}, {'value': '9.98', 'groupId': 'OG001', 'lowerLimit': '7.40', 'upperLimit': '13.45'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.33', 'groupDescription': 'All Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.29', 'ciUpperLimit': '1.31', 'groupDescription': 'AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.58', 'groupDescription': 'Non-AIDS defining Malignancies: Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': "Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.", 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Density Rate Per 1000 Participant-Years for Incidence of Liver Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '1.45', 'upperLimit': '4.30'}, {'value': '2.55', 'groupId': 'OG001', 'lowerLimit': '1.41', 'upperLimit': '4.61'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.44', 'ciUpperLimit': '2.18', 'groupDescription': 'Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': "Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.80', 'groupId': 'OG000', 'lowerLimit': '3.24', 'upperLimit': '7.11'}, {'value': '5.34', 'groupId': 'OG001', 'lowerLimit': '3.55', 'upperLimit': '8.03'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.51', 'ciUpperLimit': '1.59', 'groupDescription': 'Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': "Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.26', 'groupId': 'OG000', 'lowerLimit': '6.13', 'upperLimit': '11.14'}, {'value': '7.43', 'groupId': 'OG001', 'lowerLimit': '5.25', 'upperLimit': '10.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.11', 'ciLowerLimit': '0.70', 'ciUpperLimit': '1.76', 'groupDescription': 'Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '2.05'}, {'value': '0.70', 'groupId': 'OG001', 'lowerLimit': '0.22', 'upperLimit': '2.16'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.25', 'ciUpperLimit': '4.93', 'groupDescription': 'Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.77', 'groupId': 'OG000', 'lowerLimit': '0.29', 'upperLimit': '2.05'}, {'value': '1.16', 'groupId': 'OG001', 'lowerLimit': '0.48', 'upperLimit': '2.79'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '0.18', 'ciUpperLimit': '2.47', 'groupDescription': 'Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.41', 'groupId': 'OG000', 'lowerLimit': '11.49', 'upperLimit': '18.07'}, {'value': '18.33', 'groupId': 'OG001', 'lowerLimit': '14.70', 'upperLimit': '22.86'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.57', 'ciUpperLimit': '1.08', 'groupDescription': 'Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.36', 'groupId': 'OG000', 'lowerLimit': '18.56', 'upperLimit': '26.94'}, {'value': '28.70', 'groupId': 'OG001', 'lowerLimit': '23.98', 'upperLimit': '34.34'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.61', 'ciUpperLimit': '0.99', 'groupDescription': 'Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'title': 'All Malignancies', 'categories': [{'measurements': [{'value': '12.49', 'groupId': 'OG000', 'lowerLimit': '9.72', 'upperLimit': '16.05'}, {'value': '13.54', 'groupId': 'OG001', 'lowerLimit': '10.44', 'upperLimit': '17.56'}]}]}, {'title': 'AIDS defining Malignancies', 'categories': [{'measurements': [{'value': '2.31', 'groupId': 'OG000', 'lowerLimit': '1.29', 'upperLimit': '4.13'}, {'value': '3.31', 'groupId': 'OG001', 'lowerLimit': '1.95', 'upperLimit': '5.62'}]}]}, {'title': 'Non-AIDS defining Malignancies', 'categories': [{'measurements': [{'value': '9.87', 'groupId': 'OG000', 'lowerLimit': '7.44', 'upperLimit': '13.09'}, {'value': '9.86', 'groupId': 'OG001', 'lowerLimit': '7.27', 'upperLimit': '13.37'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.33', 'groupDescription': 'All malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.70', 'ciLowerLimit': '0.32', 'ciUpperLimit': '1.52', 'groupDescription': 'AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.52', 'groupDescription': 'Non-AIDS defining malignancies: Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': "Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.", 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': "Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'groupId': 'OG000', 'lowerLimit': '1.21', 'upperLimit': '3.56'}, {'value': '3.37', 'groupId': 'OG001', 'lowerLimit': '2.06', 'upperLimit': '5.52'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.62', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.10', 'groupDescription': 'Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': "Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.65', 'groupId': 'OG000', 'lowerLimit': '3.97', 'upperLimit': '8.05'}, {'value': '5.99', 'groupId': 'OG001', 'lowerLimit': '4.13', 'upperLimit': '8.68'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.52', 'groupDescription': 'Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.39', 'groupId': 'OG000', 'lowerLimit': '11.41', 'upperLimit': '18.16'}, {'value': '15.64', 'groupId': 'OG001', 'lowerLimit': '12.30', 'upperLimit': '19.89'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.28', 'groupDescription': 'Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted RR and CI.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.', 'unitOfMeasure': 'events per 1000 participant-years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With All-Cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'OG000'}, {'value': '1130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'OG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000'}, {'value': '7.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6225', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.66', 'ciUpperLimit': '1.28', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'All-cause death was defined as the death due to any cause during the course of study.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who were enrolled in the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'FG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1316'}, {'groupId': 'FG001', 'numSubjects': '1130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '814'}, {'groupId': 'FG001', 'numSubjects': '596'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '502'}, {'groupId': 'FG001', 'numSubjects': '534'}]}], 'dropWithdraws': [{'type': 'Death recorded on subject summary pages', 'reasons': [{'groupId': 'FG000', 'numSubjects': '75'}, {'groupId': 'FG001', 'numSubjects': '75'}]}, {'type': 'Does not meet entrance criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '264'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '123'}, {'groupId': 'FG001', 'numSubjects': '108'}]}, {'type': 'Site closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawn due to pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Study was conducted at multiple sites between 31 March 2008 and 14 February 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1316', 'groupId': 'BG000'}, {'value': '1130', 'groupId': 'BG001'}, {'value': '2446', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Maraviroc Exposed', 'description': 'Human immunodeficiency virus- 1( HIV-1) infected, treatment-experienced adult participants, who were prescribed with maraviroc along with an optimized background antiretroviral therapy (OBT) regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'BG001', 'title': 'Maraviroc Unexposed', 'description': 'HIV-1 infected, treatment-experienced adult participants, who were not prescribed with maraviroc but with OBT regimen (in usual clinical practice following the approved local label of maraviroc), were included in this study and were observed in this study for an observation period of up to 5 years following enrollment.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '44.3', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '45.6', 'spread': '9.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '275', 'groupId': 'BG000'}, {'value': '265', 'groupId': 'BG001'}, {'value': '540', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1041', 'groupId': 'BG000'}, {'value': '865', 'groupId': 'BG001'}, {'value': '1906', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '983', 'groupId': 'BG000'}, {'value': '684', 'groupId': 'BG001'}, {'value': '1667', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '271', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '661', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': 'Unspecified', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set: All participants who were enrolled in the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2010-11-29', 'size': 599434, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-02-12T15:20', 'hasProtocol': True}, {'date': '2011-03-21', 'size': 1720914, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-02-12T15:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-12', 'studyFirstSubmitDate': '2008-04-23', 'resultsFirstSubmitDate': '2020-02-12', 'studyFirstSubmitQcDate': '2008-04-23', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-24', 'studyFirstPostDateStruct': {'date': '2008-04-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C AIDS -Defining Opportunistic Infections', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of centers for disease control and prevention category C acquired immunodeficiency syndrome (AIDS) -defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and confidence interval (CI).'}, {'measure': 'Density Rate Per 1000 Participant-Years for Incidence of Viral Encephalitis', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of viral encephalitis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.'}, {'measure': 'Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)', 'timeFrame': 'Up to 5 years following enrollment', 'description': "Density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as: AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-aids defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI."}, {'measure': 'Density Rate Per 1000 Participant-Years for Incidence of Liver Failure', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of liver failure was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.'}, {'measure': "Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'", 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.'}, {'measure': "Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'", 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI. In this outcome measure, density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.'}, {'measure': 'Density Rate Per 1000 Participant-Years for Incidence of Rhabdomyolysis', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of rhabdomyolysis was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.'}, {'measure': 'Density Rate Per 1000 Participant-Years for Incidence of Death From Liver-Related Cause', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of death from liver-related cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.'}, {'measure': 'Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with only treatment in the model to obtain the crude rate and CI.'}, {'measure': 'Adjusted Density Rate Per 1000 Participant-Years for Incidence of Centers for Disease Control and Prevention Category C Aids-Defining Opportunistic Infections', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Adjusted density rate per 1000 participant-years for incidence of centers for disease control and prevention category c aids-defining opportunistic infections was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, propensity score (PS) quartile and imputed Framingham score (FS) as covariates in the model to obtain the adjusted rate and CI.'}, {'measure': 'Adjusted Density Rate Per 1000 Participant-Years for Incidence of All Malignancies (AIDS Defining Malignancies and Non-AIDS Defining Malignancies)', 'timeFrame': 'Up to 5 years following enrollment', 'description': "Adjusted density rate per 1000 participant-years for incidence of all malignancies as well as its types (categorized as AIDS defining malignancies and non-AIDS defining malignancies) were reported. AIDS defining malignancies included malignancies due to any of these: cervical cancer, Kaposi's sarcoma or lymphoma; whereas all other malignancies (except AIDS-defining) were non-AIDS defining malignancies. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI."}, {'measure': "Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible'", 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible; where definite= an event had definitely occurred; possible =an event had possibly occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events) was reported.'}, {'measure': "Adjusted Density Rate Per 1000 Participant-Years for Incidence of Myocardial Infarction or Ischemia: Events Adjudicated as 'Definite' or 'Possible' or 'Insufficient Data'", 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (definite + possible + insufficient data) was reported. Events of myocardial infarction or ischemia were adjudicated as definite or possible or insufficient data; where definite= an event had definitely occurred; possible =an event had possibly occurred; insufficient =insufficient data to determine whether an event had occurred. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI. In this outcome measure, adjusted density rate per 1000 participant-years for incidence of myocardial infarction or ischemia (which included sum of definite + possible events + insufficient data) was reported.'}, {'measure': 'Adjusted Density Rate Per 1000 Participant-Years for Incidence of Death Due to Any Cause', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'Adjusted density rate per 1000 participant-years for incidence of death due to any cause was reported. Density rate was calculated as the number of events (n) per 1000 participant-years at risk. Poisson regressions were fit to the categorical events with treatment as the main effect, PS quartile and imputed FS as covariates in the model to obtain the adjusted rate and CI.'}, {'measure': 'Percentage of Participants With All-Cause Mortality', 'timeFrame': 'Up to 5 years following enrollment', 'description': 'All-cause death was defined as the death due to any cause during the course of study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Maraviroc', 'HIV-1', 'Safety', 'Non-interventional'], 'conditions': ['Human Immunodeficiency Virus']}, 'descriptionModule': {'briefSummary': 'The study will assess if use of maraviroc along with an optimized background regimen of antiretroviral drugs in usual clinical practice is as safe as using only an optimized regimen of antiretroviral drugs.', 'detailedDescription': 'All patients meeting the study eligibility criteria at participating sites will be invited to participate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Treatment experienced, HIV-1 infected patients in routine clinical practice.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment experienced, HIV-1 infected patients\n* 18 years or older\n* Receive an approved assay for determination of HIV-1 tropism\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* Using CCR5 inhibitor other than maraviroc'}, 'identificationModule': {'nctId': 'NCT00665561', 'acronym': 'POEM', 'briefTitle': "Prospective Observational Epidemiologic Study of Maraviroc's Safety", 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'AN INTERNATIONAL, MULTICENTER, PROSPECTIVE OBSERVATIONAL STUDY OF THE SAFETY OF MARAVIROC USED WITH OPTIMIZED BACKGROUND THERAPY IN TREATMENT-EXPERIENCED HIV-1 INFECTED PATIENTS', 'orgStudyIdInfo': {'id': 'A4001067'}, 'secondaryIdInfos': [{'id': '2007-006148-24', 'type': 'EUDRACT_NUMBER'}, {'id': 'POEM', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Maraviroc exposed', 'interventionNames': ['Drug: Maraviroc along with an optimized background antiretroviral drug regimen']}, {'label': 'Maraviroc unexposed', 'interventionNames': ['Drug: Optimized background antiretroviral drug regimen without maraviroc']}], 'interventions': [{'name': 'Maraviroc along with an optimized background antiretroviral drug regimen', 'type': 'DRUG', 'otherNames': ['Selzentry, Celsentri'], 'description': 'Maraviroc prescribed per approved local label.', 'armGroupLabels': ['Maraviroc exposed']}, {'name': 'Optimized background antiretroviral drug regimen without maraviroc', 'type': 'DRUG', 'description': 'Optimized background antiretroviral therapy prescribed per approved local label and treatment guidelines.', 'armGroupLabels': ['Maraviroc unexposed']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36201', 'city': 'Hobson City', 'state': 'Alabama', 'country': 'United States', 'facility': 'Health Services Center', 'geoPoint': {'lat': 33.62149, 'lon': -85.84413}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'AAC/Davis Clinic', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Infectious Diseases Center', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '93301', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Office of Franco Antonio Felizarta MD', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '91505', 'city': 'Burbank', 'state': 'California', 'country': 'United States', 'facility': 'Providence Clinical Research', 'geoPoint': {'lat': 34.18084, 'lon': -118.30897}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Lalla-Reddy Medical Corporation', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'Bickerstaff Pediatric Family HIV Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '90028', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LA Gay and Lesbian Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Office of Peter J. 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