Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT00098293
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2004-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}, {'id': 'D015215', 'term': 'Zidovudine'}, {'id': 'D019259', 'term': 'Lamivudine'}, {'id': 'C098320', 'term': 'efavirenz'}], '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'}, {'id': 'D013936', 'term': 'Thymidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D016047', 'term': 'Zalcitabine'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}]}}, '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}, 'limitationsAndCaveats': {'description': 'Following DSMB decision to discontinue maraviroc 300 mg once daily, inferential statistical analyses was performed between maraviroc 300 mg twice daily and efavirenz 600 mg once daily only. Data at Week 24 was not analyzed as planned in protocol.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.', 'otherNumAtRisk': 174, 'otherNumAffected': 151, 'seriousNumAtRisk': 174, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Maraviroc Twice Daily + CBV (DB and OL)', 'description': "Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.", 'otherNumAtRisk': 360, 'otherNumAffected': 319, 'seriousNumAtRisk': 360, 'seriousNumAffected': 77}, {'id': 'EG002', 'title': 'Efavirenz Once Daily + CBV (DB and OL)', 'description': "Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.", 'otherNumAtRisk': 361, 'otherNumAffected': 327, 'seriousNumAtRisk': 361, 'seriousNumAffected': 82}, {'id': 'EG003', 'title': 'Maraviroc Twice Daily + CBV (SP)', 'description': 'Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily until maraviroc was commercially or otherwise available.', 'otherNumAtRisk': 127, 'otherNumAffected': 0, 'seriousNumAtRisk': 127, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 53}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 90}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 111}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 38}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 138}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 132}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 61}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 60}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 64}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 49}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 56}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 78}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 36}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 44}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin papilloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 62}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 116}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 109}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 105}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 44}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 51}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 66}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lipodystrophy acquired', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 21}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 26}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 56}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myocardial infarciton', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bicuspid aortic valve', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haematotympanum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diabetic eye disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Uveitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mesenteric vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sudden cardiac death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Biliary colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatitis toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertransaminasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anal fistula infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anogenital warts', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Appendicitis perforated', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cryptosporidiosis infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Disseminated tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatitis A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatitis C', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Meningitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Meningitis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neurosyphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Parasitic gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pelvic inflamatory disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Penile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Peritoneal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumocystis jiroveci infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumocystis jiroveci pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary tuberculosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinobronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syphilis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Chest injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Concussion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Heart injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Human bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Jaw fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Multiple fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pubis fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rib fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Spinal compression fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Whiplash injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood lactate dehydrogenase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Gama-glutamytransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "Castleman's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Fibroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "Hoadgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "Kaposi's sarcoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Metastases to bone', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Metastatic neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Multiple myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nasopharyngeal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thyroid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vulval neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cranial nerve paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dysarthria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspraxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Monoparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Thoracic outlet syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vascular demetia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abortion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Completed suicide', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug dependence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Post-traumatic stress disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Calculus bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cervix haemorrhage uterine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epididymitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Uterine cervical laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug eruption', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Penile ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash erythematous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash pruritic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Drug abuser', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Pregnancy of partner', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Cholecystectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Finger amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Back injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 174, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 360, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 361, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Less than 400 copies/mL', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '70.6', 'groupId': 'OG001'}, {'value': '73.1', 'groupId': 'OG002'}]}]}, {'title': 'Less than 50 copies/mL', 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}, {'value': '65.3', 'groupId': 'OG001'}, {'value': '69.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-3.0', 'ciLowerLimit': '-9.5', 'groupDescription': 'Less than 400 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% confidence interval (CI) based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\\>) -10%.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-4.2', 'ciLowerLimit': '-10.9', 'groupDescription': 'Less than 50 copies/mL: Treatment difference in percentages stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG001', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Less than 400 copies/mL', 'categories': [{'measurements': [{'value': '75.00', 'groupId': 'OG000'}, {'value': '78.27', 'groupId': 'OG001'}]}]}, {'title': 'Less than 50 copies/mL', 'categories': [{'measurements': [{'value': '70.00', 'groupId': 'OG000'}, {'value': '74.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-4.1', 'ciLowerLimit': '-10.5', 'groupDescription': 'Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \\> -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-4.4', 'ciLowerLimit': '-11.2', 'groupDescription': 'Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata (screening viral load and geographic region) was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (PP) population included all randomized participants who had taken at least 1 dose of study medication, were treated for at least 14 days or discontinued before this time due to treatment failure, were \\>80% compliant with randomized treatment and had no violation of any inclusion or exclusion criteria, which affected efficacy. MD=F.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Less than 400 copies/mL', 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000'}, {'value': '70.6', 'groupId': 'OG001'}, {'value': '73.1', 'groupId': 'OG002'}]}]}, {'title': 'Less than 50 copies/mL', 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000'}, {'value': '65.3', 'groupId': 'OG001'}, {'value': '69.3', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.4485', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.64', 'ciUpperLimit': '1.22', 'groupDescription': 'Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), geographic region (Northern or Southern Hemisphere) as covariates was used. Odds ratio \\> 1 would favor maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.2724', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '0.61', 'ciUpperLimit': '1.15', 'groupDescription': 'Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \\> 1 would favor maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Less than 400 copies/mL', 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '61.4', 'groupId': 'OG001'}, {'value': '64.5', 'groupId': 'OG002'}]}]}, {'title': 'Less than 50 copies/mL', 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}, {'value': '62.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.3943', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.65', 'ciUpperLimit': '1.19', 'groupDescription': 'Less than 400 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \\> 1 would favor maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.1289', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.79', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1.07', 'groupDescription': 'Less than 50 copies/mL: Two-sided 95% CI was presented for the odds ratio between treatment groups. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), geographic region (Northern or Southern Hemisphere) as covariates were used. Odds ratio \\> 1 would favor maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.899', 'spread': '0.6273', 'groupId': 'OG000'}, {'value': '4.851', 'spread': '0.6511', 'groupId': 'OG001'}, {'value': '4.857', 'spread': '0.6156', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 48', 'categories': [{'measurements': [{'value': '-2.665', 'spread': '0.9454', 'groupId': 'OG000'}, {'value': '-2.240', 'spread': '1.484', 'groupId': 'OG001'}, {'value': '-2.347', 'spread': '1.455', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 96', 'categories': [{'measurements': [{'value': '-2.565', 'spread': '0.9731', 'groupId': 'OG000'}, {'value': '-1.961', 'spread': '1.575', 'groupId': 'OG001'}, {'value': '-2.053', 'spread': '1.564', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.2741', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.118', 'ciLowerLimit': '-0.094', 'ciUpperLimit': '0.329', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1077', 'groupDescription': 'Change at week 48: P-value was calculated using Analysis of Covariance (ANCOVA) with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment least squares means (LS means) adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.3899', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.100', 'ciLowerLimit': '-0.128', 'ciUpperLimit': '0.328', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1162', 'groupDescription': 'Change at week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population. Missing values for viral load at week 48 and 96 were imputed as baseline value for participants who discontinued and as last observation carried forward (LOCF) for participants who did not discontinue for maraviroc twice daily and efavirenz once daily arm and as LOCF for participants randomized to maraviroc once daily arm.'}, {'type': 'SECONDARY', 'title': 'Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG001', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': '-2.152', 'spread': '0.0713', 'groupId': 'OG000'}, {'value': '-2.262', 'spread': '0.0714', 'groupId': 'OG001'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': '-1.945', 'spread': '0.0798', 'groupId': 'OG000'}, {'value': '-2.034', 'spread': '0.0800', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2693', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.111', 'ciLowerLimit': '-0.086', 'ciUpperLimit': '0.307', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1002', 'groupDescription': 'Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4270', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.089', 'ciLowerLimit': '-0.131', 'ciUpperLimit': '0.309', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1121', 'groupDescription': 'Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Negative value would favor maraviroc.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline up to Week 48 and Week 96', 'description': 'TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all the randomized participants who had taken at least 1 dose of the study medication. TAD imputed as 0 for participants who discontinued. TAD calculated using the last non-missing value prior to the analysis time point for participants with a missing value at the analysis time point but who had not discontinued.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '360', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '274.1', 'spread': '175.45', 'groupId': 'OG000'}, {'value': '264.70', 'spread': '153.508', 'groupId': 'OG001'}, {'value': '271.87', 'spread': '133.491', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 48', 'categories': [{'measurements': [{'value': '172.50', 'spread': '205.561', 'groupId': 'OG000'}, {'value': '169.53', 'spread': '134.409', 'groupId': 'OG001'}, {'value': '143.52', 'spread': '124.931', 'groupId': 'OG002'}]}]}, {'title': 'Change at Week 96', 'categories': [{'measurements': [{'value': '183.75', 'spread': '166.454', 'groupId': 'OG000'}, {'value': '206.31', 'spread': '152.682', 'groupId': 'OG001'}, {'value': '171.50', 'spread': '149.163', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0075', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.34', 'ciLowerLimit': '7.04', 'ciUpperLimit': '45.63', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '9.827', 'groupDescription': 'Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.0020', 'groupIds': ['OG001', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.44', 'ciLowerLimit': '13.02', 'ciUpperLimit': '57.86', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.419', 'groupDescription': 'Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD4 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.', 'unitOfMeasure': 'cells per microliter (cells/µL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG001', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '938.80', 'spread': '503.392', 'groupId': 'OG000'}, {'value': '935.78', 'spread': '476.607', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 48', 'categories': [{'measurements': [{'value': '38.34', 'spread': '397.503', 'groupId': 'OG000'}, {'value': '-126.83', 'spread': '374.494', 'groupId': 'OG001'}]}]}, {'title': 'Change at Week 96', 'categories': [{'measurements': [{'value': '20.74', 'spread': '412.081', 'groupId': 'OG000'}, {'value': '-150.27', 'spread': '389.996', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '166.29', 'ciLowerLimit': '117.13', 'ciUpperLimit': '215.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '25.040', 'groupDescription': 'Change at Week 48: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '172.22', 'ciLowerLimit': '122.21', 'ciUpperLimit': '222.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '25.471', 'groupDescription': 'Change at Week 96: P-value was calculated using ANCOVA with the model including treatment arm and, as covariates, baseline CD8 count and the randomization strata (screening viral load and geographic region). The difference between the treatment LS means adjusted for the covariates was presented in addition to 2-sided 95% CI. Positive value would favor maraviroc.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure. Missing values were imputed using LOCF."}, {'type': 'SECONDARY', 'title': 'Time to Virologic Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG001', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Week 48', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not estimable because less than 50% of the participants experienced virological failure; upper confidence limit not estimable because the empirical distribution of the data rendered the algorithmic formula non-calculable.', 'groupId': 'OG000', 'lowerLimit': '354', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not estimable because less than 50% of the participants experienced virological failure; upper confidence limit not estimable because the empirical distribution of the data rendered the algorithmic formula non-calculable.', 'groupId': 'OG001', 'lowerLimit': '364', 'upperLimit': 'NA'}]}]}, {'title': 'Week 96', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median was not estimable because less than 50% of the participants experienced virological failure; confidence limits not estimable because the empirical distribution of the data rendered the algorithmic formula non-calculable.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median was not estimable because less than 50% of the participants experienced virological failure; upper confidence limit not estimable because the empirical distribution of the data rendered the algorithmic formula non-calculable.', 'groupId': 'OG001', 'lowerLimit': '691', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '0.5874', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.45', 'groupDescription': 'Week 48: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \\< 1 would favor maraviroc.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.4811', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.10', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.40', 'groupDescription': 'Week 96: P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio was calculated by fitting a Cox proportional hazards model including treatment group and the two randomization strata, HIV-1 RNA at screening and geographic region. Hazard ratio \\< 1 would favor maraviroc.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 48, Week 96', 'description': 'Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up \\[LTFU\\];new anti-retroviral drug added \\[except background drug change to drug of same class\\];or on open label for early non-response or rebound). Failure:at Time 0 if level not \\<400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level \\<400 copies/mL(2 consecutive visits);failure if level \\>=400 copies/mL(2 consecutive visits) or 1 visit \\>=400 copies/mL followed by permanent discontinuation of drug or LTFU.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population; Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Baseline: R5; Treatment failure: R5', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: X4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: DM', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: R5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: X4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: DM', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, time of failure through Week 48', 'description': 'Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} \\[R5\\], C-X-C chemokine receptor type 4 {CXCR4} \\[X4\\], Dual/mixed \\[DM\\], or Non-reportable/Non-phenotypable \\[NR/NP\\]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load \\<500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline."}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Baseline: R5; Treatment failure: R5', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: X4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: DM', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: R5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: X4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: DM', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: NR/NP; Treatment failure: R5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: NR/NP; Treatment failure: X4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: NR/NP; Treatment failure: DM', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: NR/NP; Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, time of failure through Week 96', 'description': 'Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load \\<500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response and had tropism assessment at baseline."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Resistance to Zidovudine: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Resistance to Lamivudine: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Resistance to Efavirenz: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Resistance to Maraviroc: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not summarized since treatment arm was stopped at Week 16 as it failed to meet pre-specified criteria.', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data not summarized as maraviroc resistance was not relevant to efavirenz activity.', 'groupId': 'OG002'}]}]}, {'title': 'Resistance to Zidovudine: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Resistance to Lamivudine: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Resistance to Efavirenz: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Resistance to Maraviroc: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data not summarized since treatment arm was stopped at Week 16 as it failed to meet pre-specified criteria.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data not summarized since Week 96 analysis included participants who experienced TLOVR defined virologic failure in addition to those with treatment failure.', 'groupId': 'OG001'}, {'value': 'NA', 'comment': 'Data not summarized as maraviroc resistance was not relevant to efavirenz activity.', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, time of failure through Week 48, Week 96', 'description': 'Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load \\>500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'n' is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Any Zid/Lam Mutation: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Any TAM Mutation: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'K65R Mutation: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'M184V/I Mutation: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Other NRTI Mutation: Week 48 (n= 20, 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Zid/Lam Mutation: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Any TAM Mutation: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'K65R Mutation: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'M184V/I Mutation: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Other NRTI Mutation: Week 96 (n= 27, 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, time of failure through Week 48, Week 96', 'description': 'Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all the randomized participants who had taken at least 1 dose of the study medication. 'n' is signifying those participants who experienced treatment failure, defined as discontinuation due to insufficient response at specified time points for each arm group respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '361', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG001', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'L100I Mutation: Week 48 (n= 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'K103N Mutation: Week 48 (n= 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'V106M Mutation: Week 48 (n= 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'V108I Mutation: Week 48 (n= 43, 15)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Y181C/I Mutation: Week 48 (n= 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Y188L Mutation: Week 48 (n= 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'G190S/A Mutation: Week 48 (n= 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'P225H Mutation: Week 48 (n= 43, 15)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'L100I Mutation: Week 96 (n= 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'K103N Mutation: Week 96 (n= 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'V106M Mutation: Week 96 (n= 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'V108I Mutation: Week 96 (n= 55, 23)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Y181C/I Mutation: Week 96 (n= 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Y188L Mutation: Week 96 (n= 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'G190S/A Mutation: Week 96 (n= 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'P225H Mutation: Week 96 (n= 55, 23)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening, time of failure through Week 48, Week 96', 'description': 'Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load \\>500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population; n=participants with treatment failure at specified time points for each arm group respectively. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination focus shifted from efficacy, safety to only safety as reflected in abbreviated set of efficacy noted in amended planned analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, \\>3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed because of insufficient diversity amongst participants with respect to baseline resistance due to the study entry criteria regarding baseline resistance.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'OG000'}, {'value': '360', 'groupId': 'OG001'}, {'value': '361', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)', 'description': 'Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily for the remainder of the study.'}, {'id': 'OG001', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG002', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Less than 400 copies/mL', 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000'}, {'value': '61.4', 'groupId': 'OG001'}, {'value': '64.5', 'groupId': 'OG002'}]}]}, {'title': 'Less than 50 copies/mL', 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000'}, {'value': '56.9', 'groupId': 'OG001'}, {'value': '62.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-3.2', 'ciLowerLimit': '-10.2', 'groupDescription': 'Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was greater than (\\>) -10%.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-5.8', 'ciLowerLimit': '-12.8', 'groupDescription': 'Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Step down procedure used to control for multiple comparisons.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was to be concluded if the lower bound of the 1-sided 97.5% CI was \\> -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all the randomized participants who had taken at least 1 dose of the study medication. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F).'}, {'type': 'POST_HOC', 'title': 'Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG001', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Less than 400 copies/mL', 'categories': [{'measurements': [{'value': '73.3', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}]}]}, {'title': 'Less than 50 copies/mL', 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000'}, {'value': '68.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.6', 'ciLowerLimit': '-6.4', 'groupDescription': 'Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.2', 'ciLowerLimit': '-7.4', 'groupDescription': 'Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F)."}, {'type': 'POST_HOC', 'title': 'Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 for Enhanced Sensitivity Trofile Assay (ESTA) R5 Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '311', 'groupId': 'OG000'}, {'value': '303', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc Twice Daily + CBV (DB)', 'description': 'Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}, {'id': 'OG001', 'title': 'Efavirenz Once Daily + CBV (DB)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase.'}], 'classes': [{'title': 'Less than 400 copies/mL', 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000'}, {'value': '64.4', 'groupId': 'OG001'}]}]}, {'title': 'Less than 50 copies/mL', 'categories': [{'measurements': [{'value': '58.8', 'groupId': 'OG000'}, {'value': '62.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.4', 'ciLowerLimit': '-7.9', 'groupDescription': 'Less than 400 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Percentage', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '-3.9', 'ciLowerLimit': '-11.5', 'groupDescription': 'Less than 50 copies/mL: Treatment difference in percentage stratified by randomization strata was presented along with the lower bound of the 1-sided 97.5% CI based on the normal approximation to the binomial distribution. Positive value would favor maraviroc. Due to its post-hoc nature, this analysis was considered descriptive only rather than inferential.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96', 'description': 'Percentage of participants with HIV-1 RNA levels of less than 400 copies/mL and less than 50 copies/mL were not analyzed for maraviroc once daily, then twice daily arm in order to avoid misinterpretation due to possible bias due to the fact that only a non-random sample of participants in the terminated arm were re-assayed with ESTA.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population; 'N' number of participants analyzed included ESTA R5 participants who had R5 tropic virus by ESTA at screening. Missing data (MD) imputed as failure (F); that is, participants with missing data classified as not achieving the viral load criterion (MD=F)."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maraviroc Once Daily + CBV (DB)', 'description': "Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant's Week 96 visit."}, {'id': 'FG001', 'title': 'Maraviroc Twice Daily + CBV (DB and OL)', 'description': "Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase."}, {'id': 'FG002', 'title': 'Efavirenz Once Daily + CBV (DB and OL)', 'description': "Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase."}, {'id': 'FG003', 'title': 'Maraviroc Twice Daily + CBV (OL)', 'description': 'Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase.'}, {'id': 'FG004', 'title': 'Maraviroc Twice Daily + CBV (SP)', 'description': 'Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily until maraviroc was commercially or otherwise available.'}], 'periods': [{'title': 'Double-blind (DB) Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '368'}, {'groupId': 'FG002', 'numSubjects': '372'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '360'}, {'groupId': 'FG002', 'numSubjects': '361'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '202'}, {'groupId': 'FG002', 'numSubjects': '202'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '177'}, {'groupId': 'FG001', 'numSubjects': '166'}, {'groupId': 'FG002', 'numSubjects': '170'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participant Defaulted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '64'}, {'groupId': 'FG002', 'numSubjects': '30'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Randomized, Not Treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Between DB and OL Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '202'}, {'groupId': 'FG002', 'numSubjects': '202'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '202'}, {'groupId': 'FG002', 'numSubjects': '199'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Did Not Enter Open-label Phase', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Open-label (OL) Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '202'}, {'groupId': 'FG002', 'numSubjects': '199'}, {'groupId': 'FG003', 'numSubjects': '130'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '177'}, {'groupId': 'FG002', 'numSubjects': '158'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '65'}, {'groupId': 'FG004', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Participant Defaulted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '20'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}, {'title': 'Supplemental Phase (SP)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '94'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '8'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '22'}]}]}], 'preAssignmentDetails': 'Data Safety Monitoring Board (DSMB) recommended termination of maraviroc once daily treatment after interim analysis at nominal week 16, 130 participants of 177 randomized were switched to open-label (OL) maraviroc twice daily.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '174', 'groupId': 'BG000'}, {'value': '360', 'groupId': 'BG001'}, {'value': '361', 'groupId': 'BG002'}, {'value': '895', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Maraviroc Once Daily + CBV (DB)', 'description': "Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant's Week 96 visit."}, {'id': 'BG001', 'title': 'Maraviroc Twice Daily + CBV (DB and OL)', 'description': "Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant's Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase."}, {'id': 'BG002', 'title': 'Efavirenz Once Daily + CBV (DB and OL)', 'description': 'Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir \\[CBV\\]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '18 to 24 years', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}]}]}, {'title': '25 to 34 years', 'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}, {'value': '314', 'groupId': 'BG003'}]}]}, {'title': '35 to 44 years', 'categories': [{'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '141', 'groupId': 'BG002'}, {'value': '331', 'groupId': 'BG003'}]}]}, {'title': '45 to 54 years', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '140', 'groupId': 'BG003'}]}]}, {'title': '55 to 64 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}]}, {'title': 'Greater than or equal to 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}, {'value': '250', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '130', 'groupId': 'BG000'}, {'value': '256', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}, {'value': '645', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 916}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-07', 'studyFirstSubmitDate': '2004-12-06', 'resultsFirstSubmitDate': '2012-07-09', 'studyFirstSubmitQcDate': '2004-12-06', 'lastUpdatePostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-05', 'studyFirstPostDateStruct': {'date': '2004-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 96', 'timeFrame': 'Week 96'}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Viral Load of Less Than 400 Copies/Milliliter [Copies/mL] and Less Than 50 Copies/mL of Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) at Week 48 for Full Analysis Set (FAS) Population', 'timeFrame': 'Week 48'}, {'measure': 'Percentage of Participants With Viral Load of Less Than 400 Copies/mL and Less Than 50 Copies/mL of HIV-1 RNA at Week 48 for Per Protocol (PP) Population', 'timeFrame': 'Week 48', 'description': 'Percentage of participants with viral load of less than 400 copies/mL and less than 50 copies/mL of HIV-1 RNA were not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 48 Analyzed Using Logistic Regression', 'timeFrame': 'Week 48'}, {'measure': 'Percentage of Participants With HIV-1 RNA Levels of Less Than 400 Copies/mL and Less Than 50 Copies/mL at Week 96 Analyzed Using Logistic Regression', 'timeFrame': 'Week 96'}, {'measure': 'Change From Baseline in Log 10-transformed Plasma Viral Load (HIV-1 RNA) Levels at Week 48 and 96', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Change from baseline in log 10-transformed plasma viral load (HIV-1 RNA) levels (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.'}, {'measure': 'Time-Averaged Difference (TAD) in log10-transformed HIV-1 RNA Levels', 'timeFrame': 'Baseline up to Week 48 and Week 96', 'description': 'TAD from baseline was calculated as area under the curve (AUC) of HIV-1 RNA load (log10 copies/mL) divided by time period minus baseline HIV-1 RNA load (log10 copies/mL). Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose. Data not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.'}, {'measure': 'Change From Baseline in Lymphocyte Cluster of Differentiation 4 (CD4) Count at Week 48 and 96', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.'}, {'measure': 'Change From Baseline in Lymphocyte Cluster of Differentiation 8 (CD8) Count at Week 48 and 96', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose. Change from baseline in lymphocyte CD8 count at Week 48 and 96 was not analyzed for participants originally randomized to maraviroc once daily arm since after termination, focus was shifted from efficacy and safety to only safety as reflected in the abbreviated set of efficacy measures noted in the amended planned analysis.'}, {'measure': 'Time to Virologic Failure', 'timeFrame': 'Week 48, Week 96', 'description': 'Time to virologic failure based on observed HIV-1 RNA levels and failure events (death;permanent discontinuation of drug;lost to follow-up \\[LTFU\\];new anti-retroviral drug added \\[except background drug change to drug of same class\\];or on open label for early non-response or rebound). Failure:at Time 0 if level not \\<400 copies/mL(2 consecutive visits) before events or last available visit;at time of earliest event if level \\<400 copies/mL(2 consecutive visits);failure if level \\>=400 copies/mL(2 consecutive visits) or 1 visit \\>=400 copies/mL followed by permanent discontinuation of drug or LTFU.'}, {'measure': 'Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48', 'timeFrame': 'Baseline, time of failure through Week 48', 'description': 'Number of participants per tropism status (C-X-C chemokine receptor 5 {CCR5} \\[R5\\], C-X-C chemokine receptor type 4 {CXCR4} \\[X4\\], Dual/mixed \\[DM\\], or Non-reportable/Non-phenotypable \\[NR/NP\\]) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure: discontinuation due to insufficient clinical response. Tropism result was censored for participants with viral load \\<500 copies/mL at time of treatment failure categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as last on treatment assessment.'}, {'measure': 'Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 96', 'timeFrame': 'Baseline, time of failure through Week 96', 'description': 'Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 96 visit. Treatment failure defined as insufficient clinical response. Tropism result was censored for participants with viral load \\<500 copies/mL at time of treatment failure categorized as BLQ. The assessment for time of treatment failure was defined as last on treatment assessment.'}, {'measure': 'Number of Participants With Phenotypic Resistance at Time of Treatment Failure Through Week 48 and 96', 'timeFrame': 'Screening, time of failure through Week 48, Week 96', 'description': 'Phenotypic resistance to nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) assessed at screening by Monogram Bioscience PhenoSense genotype (MBPSGT) assay, repeated if viral load \\>500 copies/mL at treatment failure through week 48, 96. Phenotypic resistance to maraviroc was assumed in maraviroc treatment failures with X4-using virus and in R5 maraviroc treatment failures using Monogram Bioscience PhenoSense Entry Assay. Phenotypic resistance to zidovudine, lamivudine, efavirenz and maraviroc at time of failure was summarized.'}, {'measure': 'Number of Participants With NRTI Associated Mutations at Time of Treatment Failure Through Week 48 and 96', 'timeFrame': 'Screening, time of failure through Week 48, Week 96', 'description': 'Genotypic resistance to NRTIs was assessed by identification of relevant mutations at screening using MBPSGT assay and repeated for all participants with HIV-1 viral load more than 500 copies/mL at treatment failure through week 48 and week 96. Following mutations associated with NRTIs were summarized at time of failure: Any zidovudine/lamivudine (Zid/Lam), Any thymidine analogue-associated mutation (TAM), methionine (M) to valine/isoleucine (V/I) substitution at residue (r) 184 (M184V/I), lysine (K) to arginine (R) substitution at residue 65 (K65R) and any other NRTI mutations.'}, {'measure': 'Number of Participants With Efavirenz Associated Mutations at Time of Treatment Failure Through Week 48 and 96', 'timeFrame': 'Screening, time of failure through Week 48, Week 96', 'description': 'Genotypic resistance: mutations at screening by MBPSGT assay, repeated if viral load \\>500 copies/mL at treatment failure through week 48, 96. Efavirenz mutation:lysine to aspargine at r103(K103N);tyrosine to cysteine/isoleucine at r181(Y181C/I);tyrosine to cysteine/leucine/histidine at r188(Y188C/L/H);glycine to alanine/serine at r190(G190A/S);valine to alanine to r106(V106A);leucine to isoleucine at r100(L100I);alanine to glycine at r98(A98G);lysine to glutamic acid at r101(K101E);valine to isoleucine at r108(V108I);proline to histidine at r225(P225H);methionine to leucine at r230(M230L).'}, {'measure': 'Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL at Week 48 and Week 96 by Overall Susceptibility Score (OSS) at Screening', 'timeFrame': 'Baseline, Week 48, Week 96', 'description': 'Association between baseline resistance and virological response was assessed as percentage of participants with HIV-1RNA levels less than 50 copies/mL by OSS at screening. OSS categorized as 0, 1, 2, \\>3 (maximum value of 6) and calculated as the sum of the net assessment of in-vitro phenotypic and genotypic susceptibility using a binary scoring system (0= resistant, 1= sensitive or susceptible) for each antiretroviral agent in OBT. Higher scores indicate greater susceptibility.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aids', 'HIV'], 'conditions': ['HIV-1']}, 'referencesModule': {'references': [{'pmid': '30192390', 'type': 'DERIVED', 'citation': 'Vourvahis M, McFadyen L, Nepal S, Valluri SR, Fang A, Fate GD, Wood LS, Marshall JC, Chan PLS, Nedderman A, Haynes J, Savage ME, Clark A, Smith KY, Heera J. No Clinical Impact of CYP3A5 Gene Polymorphisms on the Pharmacokinetics and/or Efficacy of Maraviroc in Healthy Volunteers and HIV-1-Infected Subjects. J Clin Pharmacol. 2019 Jan;59(1):139-152. doi: 10.1002/jcph.1306. Epub 2018 Sep 7.'}, {'pmid': '21388938', 'type': 'DERIVED', 'citation': 'MacInnes A, Lazzarin A, Di Perri G, Sierra-Madero JG, Aberg J, Heera J, Rajicic N, Goodrich J, Mayer H, Valdez H. Maraviroc can improve lipid profiles in dyslipidemic patients with HIV: results from the MERIT trial. HIV Clin Trials. 2011 Jan-Feb;12(1):24-36. doi: 10.1310/hct1201-24.'}, {'pmid': '20949133', 'type': 'DERIVED', 'citation': 'Funderburg N, Kalinowska M, Eason J, Goodrich J, Heera J, Mayer H, Rajicic N, Valdez H, Lederman MM. Effects of maraviroc and efavirenz on markers of immune activation and inflammation and associations with CD4+ cell rises in HIV-infected patients. PLoS One. 2010 Oct 6;5(10):e13188. doi: 10.1371/journal.pone.0013188.'}, {'pmid': '20151839', 'type': 'DERIVED', 'citation': 'Cooper DA, Heera J, Goodrich J, Tawadrous M, Saag M, Dejesus E, Clumeck N, Walmsley S, Ting N, Coakley E, Reeves JD, Reyes-Teran G, Westby M, Van Der Ryst E, Ive P, Mohapi L, Mingrone H, Horban A, Hackman F, Sullivan J, Mayer H. Maraviroc versus efavirenz, both in combination with zidovudine-lamivudine, for the treatment of antiretroviral-naive subjects with CCR5-tropic HIV-1 infection. J Infect Dis. 2010 Mar 15;201(6):803-13. doi: 10.1086/650697.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001026&StudyName=Trial%20of%20Maraviroc%20%28UK-427%2C857%29%20in%20Combination%20with%20Zidovudine/Lamivudine%20versus%20Efavirenz%20in%20Combination%20with%20Zidovudine/Lamivudine', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Maraviroc (UK-427,857), a selective and reversible CCR5 coreceptor antagonist, has been shown to be active in vitro against a wide range of clinical isolates (including those resistant to existing classes). In HIV-1 infected patients, maraviroc (UK-427,857) given as monotherapy for 10 days reduced HIV-1 viral load by up to 1.6 log, consistent with currently available agents. Safety and toleration have been studied in over 400 subjects for up to 28 days at 300 mg twice daily. No significant effects were seen on the QTc interval. The goal of this study is to compare the safety and efficacy of maraviroc (UK-427,857) versus efavirenz, when each are combined with two other antiretroviral agents, in patients who are previously naive to antiretroviral therapy. This study will involve approximately 200 centers from around the world to achieve a total randomized subject population of 1071 subjects. Patients will be randomly assigned to one of three groups: maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily), Maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily) or efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily). The study will enroll over approximately an 18 month period (5 months Phase 2b run-in, 13 months Phase 3) with 96 weeks of treatment. This may be extended for an additional 3 years depending on the results at 96 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, 60, 72, 84 and 96. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 48 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24, 48 and 96. A computerized tomography (CT) scan will also be performed, at selected centers, at study entry and week 96. Patients will be asked to complete a symptom distress questionnaire at study entry, weeks 12, 24, 48 and 96.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men or women at least 16 years of age (or minimum age as determined by local regulatory authorities)\n* HIV-1 RNA viral load of greater than or equal to 2, 000 copies/mL\n* A negative urine pregnancy test at the baseline visit for Women of Child Bearing Potential (WOCBP)\n* Effective barrier contraception for WOCBP and males\n\nExclusion Criteria:\n\n* Suspected or documented active, untreated HIV-1 related opportunistic infection (OI) or other condition requiring acute therapy\n* Treatment for an active opportunistic infection, or unexplained temperature \\>38.5 degrees Celsius for 7 consecutive days\n* Prior treatment with efavirenz, zidovudine or lamivudine or with any other antiretroviral therapy for more than 14 days at any time\n* Active alcohol or substance abuse sufficient, in the Investigator's judgment, to prevent adherence to study medication and/or follow up\n* Lactating women, or planned pregnancy during the trial period\n* Suspected primary (acute) HIV-1 infection\n* Previous therapy with a potentially myelosuppressive, neurotoxic, hepatotoxic and/or cytotoxic agent within 30 days prior to randomization or the expected need for such therapy during the study period\n* Documented or suspected acute hepatitis or pancreatitis within 30 days prior to randomization\n* Significantly elevated liver enzymes or cirrhosis\n* Significant neutropenia, anemia or thrombocytopenia\n* Malabsorption or an inability to tolerate oral medications\n* Symptomatic postural hypotension or severe cardiovascular or cerebrovascular disease\n* Certain medications\n* Genotypic or phenotypic resistance to efavirenz, zidovudine or lamivudine\n* X4- or dual/mixed-tropic virus or repeated assay failure\n* Any other clinical condition that, in the Investigator's judgement, would potentially compromise study compliance or the ability to evaluate safety/efficacy"}, 'identificationModule': {'nctId': 'NCT00098293', 'acronym': 'MERIT', 'briefTitle': 'Trial of Maraviroc (UK-427,857) in Combination With Zidovudine/Lamivudine Versus Efavirenz in Combination With Zidovudine/Lamivudine', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Comparative Trial Of A Novel CCR5 Antagonist, UK-427,857, In Combination With Zidovudine/Lamivudine Versus Efavirenz In Combination With Zidovudine/Lamivudine For The Treatment Of Antiretroviral-Naive HIV-1 Infected Subjects', 'orgStudyIdInfo': {'id': 'A4001026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Maraviroc + Zidovudine/Lamivudine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'interventionNames': ['Drug: Efavirenz + Zidovudine/Lamivudine']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Following a review of the interim analysis data, the DSMB recommended to terminate the UK-427,857 300 mg QD arm based on pre-specified protocol non-inferiority criteria not being met for the QD arm versus efavirenz', 'interventionNames': ['Drug: Maraviroc (UK-427,857) + Zidovudine/Lamivudine']}], 'interventions': [{'name': 'Maraviroc + Zidovudine/Lamivudine', 'type': 'DRUG', 'description': 'maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)', 'armGroupLabels': ['1']}, {'name': 'Efavirenz + Zidovudine/Lamivudine', 'type': 'DRUG', 'description': 'efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)', 'armGroupLabels': ['3']}, {'name': 'Maraviroc (UK-427,857) + Zidovudine/Lamivudine', 'type': 'DRUG', 'description': 'maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily)', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35294-2050', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90069', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94602', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115-3029', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33133', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33139', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '34243', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02118-2393', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '68106', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11355', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '45267-0405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '73104-5068', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29206', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '75208', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77006', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77098', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': '98372', 'city': 'Puyallup', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.18538, 'lon': -122.2929}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '1684', 'city': 'El Palomar', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.61771, 'lon': -58.60153}}, {'zip': 'Q8300PMB', 'city': 'Neuquén', 'state': 'Neuquén Province', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -38.95078, 'lon': -68.0592}}, {'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1202ABB', 'city': 'Ciudad de Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'zip': 'C1406FWY', 'city': 'Ciudad de Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'zip': 'C1282AEN', 'city': 'Ciudad de Buenos', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'city': 'Provincia de Buenos Aires', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'city': 'Provincia de Santa Fe', 'country': 'Argentina', 'facility': 'Pfizer Investigational Site'}, {'zip': '2134', 'city': 'Burwood', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.88333, 'lon': 151.1}}, {'zip': '2010', 'city': 'Darlinghurst', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '2010', 'city': 'Surrey Hills', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site'}, {'zip': '2145', 'city': 'Wentworthville', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.80652, 'lon': 150.96785}}, {'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '4220', 'city': 'Miami', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -28.07173, 'lon': 153.44158}}, {'zip': '3068', 'city': 'Fitzroy North', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -37.78862, 'lon': 144.97885}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '3141', 'city': 'South Yarra', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -37.83834, 'lon': 144.99149}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': 'B-3000 Leuven', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '20210-030', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'zip': 'T2R0X7', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6G 2C8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V6B 1R3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 2C7', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 2T1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3A 1R9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8N 3Z5', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4P9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 5B1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2X 2P4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1V 4G2', 'city': 'Sainte-Foy', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.78139, 'lon': -71.29217}}, {'zip': '50011', 'city': 'Antella (FI)', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.72774, 'lon': 11.32233}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '20127', 'city': 'Milan', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '41100', 'city': 'Modena', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00185', 'city': 'Roma', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10149', 'city': 'Torino', 'country': 'Italy', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '14050', 'city': 'Del. Tlalpan C.P.', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site'}, {'zip': '14000', 'city': 'Del. Tlalpan, C.P.', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site'}, {'zip': '14080', 'city': 'Del. Tlalpan, C.P.', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site'}, {'zip': '14080', 'city': 'Delegacion Tlalpan C. P', 'state': 'Mexico City', 'country': 'Mexico', 'facility': 'Pfizer Investigational Site'}, {'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '15-540', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '85-030', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '41-500', 'city': 'Chorzów', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31-531', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '71-455', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '01-201', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '00731', 'city': 'Ponce', 'country': 'Puerto Rico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.01031, 'lon': -66.62398}}, {'zip': '00935', 'city': 'Rio Piedras', 'country': 'Puerto Rico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.39745, 'lon': -66.04989}}, {'zip': '00909', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '6065', 'city': 'Port Elizabeth', 'state': 'Eastern Cape', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'zip': '9300', 'city': 'Bloemfontein', 'state': 'Free State', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -29.12107, 'lon': 26.214}}, {'zip': '2092', 'city': 'Johannesburg', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0083', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '3000', 'city': 'Dundee', 'state': 'KwaZulu-Natal', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -28.16678, 'lon': 30.23371}}, {'city': 'Bloomfontein', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site'}, {'zip': '7405', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7550', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7705', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '7780', 'city': 'Cape Town', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -33.92584, 'lon': 18.42322}}, {'zip': '2047', 'city': 'Johannesburg', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -26.20227, 'lon': 28.04363}}, {'zip': '0132', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '0182', 'city': 'Pretoria North', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': -25.68198, 'lon': 28.17477}}, {'zip': '2013', 'city': 'Soweto, Johannesburg', 'country': 'South Africa', 'facility': 'Pfizer Investigational Site'}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '8038', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'ED4 2XU', 'city': 'Edinburgh', 'state': 'Loth', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'B9 5SS', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'BN2 1ES', 'city': 'Brighton', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.82838, 'lon': -0.13947}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW10 9NH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'W2 1NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M8 5RB', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}