Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:43 AM
Study NCT ID:
NCT00098306
Status:
COMPLETED
Last Update Posted:
2012-04-27
First Post:
2004-12-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077592', 'term': 'Maraviroc'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'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 QD, Double Blind', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.', 'otherNumAtRisk': 232, 'otherNumAffected': 170, 'seriousNumAtRisk': 232, 'seriousNumAffected': 42}, {'id': 'EG001', 'title': 'Maraviroc BID, Double Blind', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).', 'otherNumAtRisk': 235, 'otherNumAffected': 192, 'seriousNumAtRisk': 235, 'seriousNumAffected': 53}, {'id': 'EG002', 'title': 'Placebo, Double Blind', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).', 'otherNumAtRisk': 118, 'otherNumAffected': 89, 'seriousNumAtRisk': 118, 'seriousNumAffected': 20}, {'id': 'EG003', 'title': 'Maraviroc BID, Open Label', 'description': 'Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.', 'otherNumAtRisk': 327, 'otherNumAffected': 19, 'seriousNumAtRisk': 327, 'seriousNumAffected': 33}, {'id': 'EG004', 'title': 'In Study-off Drug (ISOD), Open Label', 'description': 'Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Maraviroc BID, Observation Phase', 'description': 'Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.', 'otherNumAtRisk': 250, 'otherNumAffected': 0, 'seriousNumAtRisk': 250, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'In Study-off Drug (ISOD), Observation Phase', 'description': 'Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.', 'otherNumAtRisk': 81, 'otherNumAffected': 0, 'seriousNumAtRisk': 81, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 30}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinus congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombotic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blindness unilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diverticulum intestinal haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oesophageal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rectal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatic cirrhosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hepatotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperbilirubinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Portal vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Antiphospholipid syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthritis gonococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cavernous sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cytomegalovirus chorioretinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastric infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Genital herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Groin abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HIV wasting syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Herpes simplex', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Infective myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Progressive multifocal leukoencephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rectal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urethral abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal wall abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'HIV infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lung infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Mycobacterium avium complex infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Drug toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Heat exhaustion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nuclear magnetic resonance imaging brain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lactic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Joint range of motion decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Joint warmth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rhabdomyolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Spinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sweat gland tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Speech disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumocephalus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Schizophrenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Rash generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hip surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Plasmapheresis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Stent placement', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Toe operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Peripheral embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 232, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 118, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 327, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 62, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 250, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 81, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'categories': [{'measurements': [{'value': '4.854', 'spread': '0.641', 'groupId': 'OG000'}, {'value': '4.861', 'spread': '0.614', 'groupId': 'OG001'}, {'value': '4.840', 'spread': '0.556', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.', 'unitOfMeasure': 'log10 copies/milliliter(log10 copies/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS) included all the randomized participants who had taken at least one dose of the study medication.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.818', 'spread': '0.0920', 'groupId': 'OG000'}, {'value': '-1.952', 'spread': '0.0913', 'groupId': 'OG001'}, {'value': '-1.030', 'spread': '0.1287', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.788', 'ciLowerLimit': '-1.141', 'ciUpperLimit': '-0.435', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1571', 'groupDescription': 'The difference between the treatment least square means (LS means) adjusted for the randomization strata was presented in addition to 2-sided 97.5% confidence interval (CI) as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.922', 'ciLowerLimit': '-1.275', 'ciUpperLimit': '-0.570', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1568', 'groupDescription': 'The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 24', '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 Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 24 have been imputed as baseline value for the participants who discontinued and as Last observation carried forward (LOCF) for participants who did not discontinue.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000'}, {'value': '60.4', 'groupId': 'OG001'}, {'value': '31.4', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '57.5', 'groupId': 'OG001'}, {'value': '22.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.88', 'ciLowerLimit': '1.78', 'ciUpperLimit': '4.67', 'groupDescription': 'Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (less than \\[\\<\\] 100,000 or greater than or equal to \\[\\>=\\] 100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio greater than (\\>) 1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.66', 'ciLowerLimit': '2.26', 'ciUpperLimit': '5.95', 'groupDescription': 'Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.96', 'ciLowerLimit': '2.36', 'ciUpperLimit': '6.64', 'groupDescription': 'Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.11', 'ciLowerLimit': '3.04', 'ciUpperLimit': '8.59', 'groupDescription': 'Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and 48', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL of HIV-1 RNA levels.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 0.5 log10 Decrease From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '67.7', 'groupId': 'OG000'}, {'value': '69.4', 'groupId': 'OG001'}, {'value': '45.8', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '59.9', 'groupId': 'OG000'}, {'value': '64.3', 'groupId': 'OG001'}, {'value': '35.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.60', 'ciLowerLimit': '1.63', 'ciUpperLimit': '4.13', 'groupDescription': 'Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.85', 'ciLowerLimit': '1.79', 'ciUpperLimit': '4.54', 'groupDescription': 'Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.93', 'ciLowerLimit': '1.83', 'ciUpperLimit': '4.67', 'groupDescription': 'Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.33', 'ciLowerLimit': '2.08', 'ciUpperLimit': '5.32', 'groupDescription': 'Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and 48', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL or with at least 0.5 log10 decrease from baseline of HIV-1 RNA levels.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 1.0 log10 Decrease From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '64.7', 'groupId': 'OG000'}, {'value': '67.7', 'groupId': 'OG001'}, {'value': '38.1', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '57.8', 'groupId': 'OG000'}, {'value': '63.0', 'groupId': 'OG001'}, {'value': '31.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.06', 'ciLowerLimit': '1.92', 'ciUpperLimit': '4.88', 'groupDescription': 'Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.55', 'ciLowerLimit': '2.22', 'ciUpperLimit': '5.68', 'groupDescription': 'Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.30', 'ciLowerLimit': '2.05', 'ciUpperLimit': '5.31', 'groupDescription': 'Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.03', 'ciLowerLimit': '2.50', 'ciUpperLimit': '6.51', 'groupDescription': 'Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and 48', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 400 copies/mL or with at least 1.0 log10 decrease from baseline of HIV-1 RNA levels.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000'}, {'value': '48.5', 'groupId': 'OG001'}, {'value': '24.6', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '41.8', 'groupId': 'OG000'}, {'value': '46.8', 'groupId': 'OG001'}, {'value': '16.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.43', 'ciLowerLimit': '1.46', 'ciUpperLimit': '4.04', 'groupDescription': 'Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.15', 'ciLowerLimit': '1.90', 'ciUpperLimit': '5.23', 'groupDescription': 'Week 24: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.10', 'ciLowerLimit': '2.32', 'ciUpperLimit': '7.25', 'groupDescription': 'Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.97', 'ciLowerLimit': '2.82', 'ciUpperLimit': '8.77', 'groupDescription': 'Week 48: Two-sided 95% CI was presented for the odds ratios between treatment groups with placebo as the comparator. CIs were calculated using the Wald-approximation. Logistic model with treatment, screening HIV concentrations (\\<100,000 or \\>=100,000), enfuvirtide use (Yes or No) as covariates was used. Odds ratio \\>1 favors maraviroc.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24 and 48', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data was imputed as "failure" which was defined as not meeting the criteria of less than 50 copies/mL of HIV-1 RNA levels.'}, {'type': 'SECONDARY', 'title': 'Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'CD4', 'categories': [{'measurements': [{'value': '187.5', 'spread': '149.88', 'groupId': 'OG000'}, {'value': '176.5', 'spread': '143.93', 'groupId': 'OG001'}, {'value': '178.5', 'spread': '127.09', 'groupId': 'OG002'}]}]}, {'title': 'CD8', 'categories': [{'measurements': [{'value': '941.1', 'spread': '556.53', 'groupId': 'OG000'}, {'value': '880.1', 'spread': '547.19', 'groupId': 'OG001'}, {'value': '880.4', 'spread': '489.28', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Baseline value calculated as 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 included all the randomized participants who had taken at least one dose of the study medication. 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CD4 Cell Count at Week 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '106.63', 'spread': '7.255', 'groupId': 'OG000'}, {'value': '111.08', 'spread': '7.148', 'groupId': 'OG001'}, {'value': '52.14', 'spread': '10.140', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '112.53', 'spread': '7.390', 'groupId': 'OG000'}, {'value': '122.44', 'spread': '7.284', 'groupId': 'OG001'}, {'value': '53.97', 'spread': '10.341', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '54.49', 'ciLowerLimit': '30.07', 'ciUpperLimit': '78.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.435', 'groupDescription': 'Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.94', 'ciLowerLimit': '34.63', 'ciUpperLimit': '83.26', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.378', 'groupDescription': 'Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58.56', 'ciLowerLimit': '33.66', 'ciUpperLimit': '83.46', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.677', 'groupDescription': 'Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '68.47', 'ciLowerLimit': '43.69', 'ciUpperLimit': '93.25', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.617', 'groupDescription': 'Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24 and 48', 'description': 'Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomized participants who had taken at least one 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 CD8 Cell Count at Week 24 and 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '283.48', 'spread': '30.206', 'groupId': 'OG000'}, {'value': '302.33', 'spread': '29.745', 'groupId': 'OG001'}, {'value': '-0.74', 'spread': '42.198', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '198.00', 'spread': '28.962', 'groupId': 'OG000'}, {'value': '220.40', 'spread': '28.532', 'groupId': 'OG001'}, {'value': '-15.34', 'spread': '40.503', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '284.21', 'ciLowerLimit': '182.51', 'ciUpperLimit': '385.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '51.779', 'groupDescription': 'Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '303.07', 'ciLowerLimit': '201.90', 'ciUpperLimit': '404.23', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '51.507', 'groupDescription': 'Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '213.34', 'ciLowerLimit': '115.77', 'ciUpperLimit': '310.92', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '49.679', 'groupDescription': 'Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '235.74', 'ciLowerLimit': '138.68', 'ciUpperLimit': '332.80', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '49.416', 'groupDescription': 'Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Positive value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 24 and 48', 'description': 'Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.', 'unitOfMeasure': 'cells/µL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all the randomized participants who had taken at least one 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 Virological Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'categories': [{'measurements': [{'value': '344.00', 'groupId': 'OG000', 'lowerLimit': '195.00', 'upperLimit': '372.00'}, {'value': 'NA', 'comment': 'Data was not estimable because less than 50% of participants experienced virological failure.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.00', 'comment': 'Data was not estimable because the empirical distribution of the data rendered the algorithmic formula non-calculable.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.45', 'ciLowerLimit': '0.34', 'ciUpperLimit': '0.60', 'groupDescription': 'P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \\<1 favors maraviroc.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.0001', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.38', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.50', 'groupDescription': 'P-value was calculated using Log rank test controlling for the effect of the randomization strata. Hazard ratio calculated by fitting a Cox proportional hazards model including treatment group and randomization strata. Hazard ratio \\<1 favors maraviroc.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Week 48', '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 included all the randomized participants who had taken at least one dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Week 24', 'categories': [{'measurements': [{'value': '-1.636', 'spread': '0.0789', 'groupId': 'OG000'}, {'value': '-1.741', 'spread': '0.0783', 'groupId': 'OG001'}, {'value': '-0.939', 'spread': '0.1103', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'categories': [{'measurements': [{'value': '-1.556', 'spread': '0.0876', 'groupId': 'OG000'}, {'value': '-1.720', 'spread': '0.0870', 'groupId': 'OG001'}, {'value': '-0.788', 'spread': '0.1227', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.697', 'ciLowerLimit': '-0.961', 'ciUpperLimit': '-0.432', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1347', 'groupDescription': 'Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.802', 'ciLowerLimit': '-1.065', 'ciUpperLimit': '-0.538', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1344', 'groupDescription': 'Week 24: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.767', 'ciLowerLimit': '-1.061', 'ciUpperLimit': '-0.474', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1497', 'groupDescription': 'Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.931', 'ciLowerLimit': '-1.225', 'ciUpperLimit': '-0.638', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1494', 'groupDescription': 'Week 48: The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 95% CI. Negative value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 24 and Week 48', 'description': 'TAD from baseline was calculated as area under the curve 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 the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.', 'unitOfMeasure': 'log10 copies/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomized participants who had taken at least one dose of the study medication. Missing data imputed as 0 for participants who discontinued and through last available observation for participants who did not discontinue.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.656', 'spread': '0.0949', 'groupId': 'OG000'}, {'value': '-1.824', 'spread': '0.0942', 'groupId': 'OG001'}, {'value': '-0.803', 'spread': '0.1329', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-0.853', 'ciLowerLimit': '-1.217', 'ciUpperLimit': '-0.489', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1621', 'groupDescription': 'The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '-1.021', 'ciLowerLimit': '-1.385', 'ciUpperLimit': '-0.658', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1618', 'groupDescription': 'The difference between the treatment LS means adjusted for the randomization strata was presented in addition to 2-sided 97.5% CI as an adjustment for multiplicity using a Bonferroni correction. Negative value favors maraviroc over placebo.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Week 48', '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 Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomized participants who had taken at least one dose of the study medication. Missing values for viral load at week 48 have been imputed as the baseline value for participants who discontinued and as LOCF for participants who did not discontinue.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'OG000'}, {'value': '235', 'groupId': 'OG001'}, {'value': '118', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'GSS: 0', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'GSS: 1', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}, {'title': 'GSS: 2', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'GSS: greater than or equal to 3', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'GSS: missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'PSS: 0', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'PSS: 1', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'PSS: 2', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'PSS: greater than or equal to 3', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}, {'title': 'PSS: missing', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening', 'description': "Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to \\>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS included all the randomized participants who had taken at least one dose of the study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Change in GSS by less than -3 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by -3 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by -2 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by -1 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by 0 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by 1 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by 2 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by 3 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by greater than 3 (n= 35 ,40, 47)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by less than -3 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by -3 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by -2 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by -1 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by 0 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by 1 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by 2 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by 3 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by greater than 3 (n= 35 ,40, 45)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening and time of failure through week 24', 'description': "Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to \\>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Change in GSS by less than -3 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by -3 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by -2 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by -1 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by 0 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by 1 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by 2 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by 3 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in GSS by greater than 3 (n= 44 ,52, 55)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by less than -3 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by -3 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by -2 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by -1 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by 0 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by 1 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by 2 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by 3 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Change in PSS by greater than 3 (n= 44 , 52, 53)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening and time of failure through week 48', 'description': "Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to \\>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS; 'N' (number of participants analyzed) is signifying those participants who experienced treatment failure defined as discontinuation due to discontinuation due to insufficient response. 'n' is number of participants who were evaluable for the given change in GSS and PSS score for each arm group respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Baseline: R5; Treatment failure: R5', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: X4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: DM', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5; Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: R5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: X4', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: DM', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM; Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and time of failure through week 24', '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 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load \\<500 copies/mL categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS; '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 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '62', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Baseline: R5, Treatment failure: R5', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5, Treatment failure: X4', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5, Treatment failure: DM', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: R5, Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM, Treatment failure: R5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM, Treatment failure: X4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM, Treatment failure: DM', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Baseline: DM, Treatment failure: NR/NP', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and time of failure through week 48', 'description': 'Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load \\<500 copies/mL categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS; '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': 'Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'OG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}], 'classes': [{'title': 'Week 24; Screening OSS 0 (n= 29, 27, 19)', 'categories': [{'measurements': [{'value': '-0.945', 'spread': '0.905', 'groupId': 'OG000'}, {'value': '-1.524', 'spread': '1.331', 'groupId': 'OG001'}, {'value': '-0.083', 'spread': '0.472', 'groupId': 'OG002'}]}]}, {'title': 'Week 24; Screening OSS 1 (n= 76, 86, 21)', 'categories': [{'measurements': [{'value': '-1.911', 'spread': '1.229', 'groupId': 'OG000'}, {'value': '-1.895', 'spread': '1.395', 'groupId': 'OG001'}, {'value': '-0.350', 'spread': '0.784', 'groupId': 'OG002'}]}]}, {'title': 'Week 24; Screening OSS 2 (n= 51, 65, 38)', 'categories': [{'measurements': [{'value': '-2.093', 'spread': '1.3402', 'groupId': 'OG000'}, {'value': '-2.220', 'spread': '1.0900', 'groupId': 'OG001'}, {'value': '-1.251', 'spread': '1.0800', 'groupId': 'OG002'}]}]}, {'title': 'Week 24; Screening OSS >=3 (n= 68, 53, 35)', 'categories': [{'measurements': [{'value': '-2.536', 'spread': '1.1599', 'groupId': 'OG000'}, {'value': '-2.672', 'spread': '1.1836', 'groupId': 'OG001'}, {'value': '-2.471', 'spread': '0.9200', 'groupId': 'OG002'}]}]}, {'title': 'Week 24; Screening OSS= Missing (n= 4, 3, 3)', 'categories': [{'measurements': [{'value': '-2.070', 'spread': '1.3832', 'groupId': 'OG000'}, {'value': '-3.075', 'spread': '0.5705', 'groupId': 'OG001'}, {'value': '-0.530', 'spread': '0.1726', 'groupId': 'OG002'}]}]}, {'title': 'Week 48; Screening OSS 0 (n= 29, 27, 19)', 'categories': [{'measurements': [{'value': '-0.876', 'spread': '0.8448', 'groupId': 'OG000'}, {'value': '-1.419', 'spread': '1.3042', 'groupId': 'OG001'}, {'value': '-0.088', 'spread': '0.4541', 'groupId': 'OG002'}]}]}, {'title': 'Week 48; Screening OSS 1 (n= 77, 86, 20)', 'categories': [{'measurements': [{'value': '-1.843', 'spread': '1.2452', 'groupId': 'OG000'}, {'value': '-1.868', 'spread': '1.4078', 'groupId': 'OG001'}, {'value': '-0.262', 'spread': '0.7048', 'groupId': 'OG002'}]}]}, {'title': 'Week 48; Screening OSS 2 (n= 51, 64, 38)', 'categories': [{'measurements': [{'value': '-2.146', 'spread': '1.4208', 'groupId': 'OG000'}, {'value': '-2.182', 'spread': '1.1096', 'groupId': 'OG001'}, {'value': '-1.147', 'spread': '0.9681', 'groupId': 'OG002'}]}]}, {'title': 'Week 48; Screening OSS >=3 (n= 67, 54, 36)', 'categories': [{'measurements': [{'value': '-2.427', 'spread': '1.3136', 'groupId': 'OG000'}, {'value': '-2.634', 'spread': '1.1628', 'groupId': 'OG001'}, {'value': '-2.205', 'spread': '1.0870', 'groupId': 'OG002'}]}]}, {'title': 'Week 48; Screening OSS= Missing (n= 4, 3, 3)', 'categories': [{'measurements': [{'value': '-2.106', 'spread': '1.4461', 'groupId': 'OG000'}, {'value': '-2.698', 'spread': '1.2056', 'groupId': 'OG001'}, {'value': '-0.370', 'spread': '0.1471', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24 and Week 48', 'description': 'Association between baseline resistance and virological response was assessed as change in viral load 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. Baseline value is the average of the values from screening, randomization and immediately pre-dose.', 'unitOfMeasure': 'log10copies/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS; 'N' (number of participants analyzed) is signifying those participants who were evaluable for this measure. 'n' is number of participants with given OSS score at screening for each treatment arm at particular time-point. LOCF was used to impute missing values."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Maraviroc QD, Double Blind', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'FG001', 'title': 'Maraviroc BID, Double Blind', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'FG002', 'title': 'Placebo, Double Blind', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'FG003', 'title': 'Maraviroc BID, Open Label', 'description': 'Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.'}, {'id': 'FG004', 'title': 'In Study-off Drug (ISOD), Open Label', 'description': 'Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.'}, {'id': 'FG005', 'title': 'Maraviroc BID, Observation Phase', 'description': 'Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.'}, {'id': 'FG006', 'title': 'In Study-off Drug (ISOD), Observation Phase', 'description': 'Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.'}], 'periods': [{'title': 'Double Blind', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '235'}, {'groupId': 'FG002', 'numSubjects': '118'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '241'}, {'groupId': 'FG001', 'numSubjects': '240'}, {'groupId': 'FG002', 'numSubjects': '120'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Randomized, not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Ongoing at cut-off date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '166'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Participant defaulted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Un-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Open Label', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '327'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '327'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Participant defaulted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Un-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Ongoing at cut-off date', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '269'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Observational Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '250'}, {'groupId': 'FG006', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '204'}, {'groupId': 'FG006', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'groupId': 'FG006', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '5'}, {'groupId': 'FG006', 'numSubjects': '4'}]}, {'type': 'Participant defaulted', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '34'}, {'groupId': 'FG006', 'numSubjects': '18'}]}, {'type': 'Un-specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '235', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '585', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Maraviroc QD', 'description': 'Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.'}, {'id': 'BG001', 'title': 'Maraviroc BID', 'description': 'Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT (3 to 6 drugs based on resistance testing, treatment history and safety considerations).'}, {'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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': '25 to 34 years', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}]}, {'title': '35 to 44 years', 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '253', 'groupId': 'BG003'}]}]}, {'title': '45 to 54 years', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '90', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '228', 'groupId': 'BG003'}]}]}, {'title': '55 to 64 years', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '73', 'groupId': 'BG003'}]}]}, {'title': 'Greater than or equal to 65 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Out of a total of 601 participants, data for baseline measure (age) was available for 585 participants who were treated.', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '210', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}, {'value': '528', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Out of a total of 601 participants, data for baseline measure (gender) was available for 585 participants who were treated.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 601}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-02', 'studyFirstSubmitDate': '2004-12-06', 'resultsFirstSubmitDate': '2012-04-02', 'studyFirstSubmitQcDate': '2004-12-06', 'lastUpdatePostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-04-02', 'studyFirstPostDateStruct': {'date': '2004-12-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Log 10-transformed Human Immunodeficiency Virus Ribonucleic Acid (HIV-1 RNA) Levels at Baseline', 'timeFrame': 'Baseline', 'description': 'Baseline value calculated as average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.'}, {'measure': 'Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 24', 'timeFrame': 'Baseline and Week 24', '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': 'Change From Baseline in Log 10-transformed HIV-1 RNA Levels at Week 48', 'timeFrame': 'Baseline and Week 48', '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.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL', 'timeFrame': 'Week 24 and 48'}, {'measure': 'Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 0.5 log10 Decrease From Baseline', 'timeFrame': 'Week 24 and 48'}, {'measure': 'Percentage of Participants With HIV-1 RNA Levels Less Than 400 Copies/mL or With at Least 1.0 log10 Decrease From Baseline', 'timeFrame': 'Week 24 and 48'}, {'measure': 'Percentage of Participants With HIV-1 RNA Levels Less Than 50 Copies/mL', 'timeFrame': 'Week 24 and 48'}, {'measure': 'Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Cell Count at Baseline', 'timeFrame': 'Baseline', 'description': 'Baseline value calculated as average of pre-dose measurements collected at screening and immediately pre-dose.'}, {'measure': 'Change From Baseline in CD4 Cell Count at Week 24 and 48', 'timeFrame': 'Baseline, Week 24 and 48', 'description': 'Change from baseline in CD4 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.'}, {'measure': 'Change From Baseline in CD8 Cell Count at Week 24 and 48', 'timeFrame': 'Baseline, Week 24 and 48', 'description': 'Change from baseline in CD8 cell count measured as cells/µL. Baseline value calculated as the average of pre-dose measurements collected at screening and immediately pre-dose.'}, {'measure': 'Time to Virological Failure', 'timeFrame': 'Week 48', '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': 'Time-Averaged Difference (TAD) From Baseline in log10 Transformed HIV-1 RNA Levels', 'timeFrame': 'Baseline to Week 24 and Week 48', 'description': 'TAD from baseline was calculated as area under the curve 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 the average of pre-dose measurements collected at screening, randomization, and immediately pre-dose.'}, {'measure': 'Number of Participants With Genotypic Susceptibility Scores (GSS) and Phenotypic Susceptibility Score (PSS) at Screening', 'timeFrame': 'Screening', 'description': "Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to protease inhibitors(PIs), nucleoside reverse transcriptase inhibitors(NRTIs), non-nucleoside reverse transcriptase inhibitors(NNRTIs) were evaluated at screening (not at baseline), by Monogram Biosciences PhenoSense genotyping (GT) assay. Score was determined for each drug in OBT, giving 1:drug 'sensitive'/'susceptible' and 0:'resistant'. GSS and PSS score range:0 to \\>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded."}, {'measure': 'Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure Through Week 24', 'timeFrame': 'Screening and time of failure through week 24', 'description': "Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 24 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to \\>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded."}, {'measure': 'Number of Participants With Change in GSS and PSS From Screening at the Time of Treatment Failure at Week 48', 'timeFrame': 'Screening and time of failure through week 48', 'description': "Number of participants with GSS and PSS were used as surrogates for assessing genotype and phenotype. Genotypic and phenotypic resistance to PIs, NRTIs and NNRTIs were evaluated at screening and time of treatment failure analyzed through week 48 visit, by Monogram Biosciences PhenoSense GT assay. Score was determined for each drug in OBT, giving 1: drug 'sensitive'/'susceptible' and 0: 'resistant'. GSS and PSS score range:0 to \\>3. Genotypic enfuvirtide value was used for PSS, no phenotypic enfuvirtide was recorded."}, {'measure': 'Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 24', 'timeFrame': 'Baseline and time of failure through week 24', '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 24 visit. Treatment failure defined as discontinuation due to insufficient clinical response. HIV-1 RNA viral load \\<500 copies/mL categorized as below lower limit of quantification (BLQ). The assessment for time of treatment failure was defined as the last on treatment assessment.'}, {'measure': 'Number of Participants Per Tropism Status at Baseline and at the Time of Treatment Failure Through Week 48', 'timeFrame': 'Baseline and time of failure through week 48', 'description': 'Number of participants per tropism status (R5, X4, DM, or NR/NP) at baseline and time of treatment failure analyzed through week 48 visit. Treatment failure defined as insufficient clinical response. HIV-1 RNA viral load \\<500 copies/mL categorized as BLQ. The assessment for time of treatment failure was defined as the last on treatment assessment.'}, {'measure': 'Change From Baseline in Viral Load at Week 24 and Week 48 by Overall Susceptibility Score (OSS) at Screening', 'timeFrame': 'Baseline, Week 24 and Week 48', 'description': 'Association between baseline resistance and virological response was assessed as change in viral load 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. Baseline value is the average of the values from screening, randomization and immediately pre-dose.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '34343443', 'type': 'DERIVED', 'citation': 'Lewis ME, Simpson P, Mori J, Jubb B, Sullivan J, McFadyen L, van der Ryst E, Craig C, Robertson DL, Westby M. V3-Loop genotypes do not predict maraviroc susceptibility of CCR5-tropic virus or clinical response through week 48 in HIV-1-infected, treatment-experienced persons receiving optimized background regimens. Antivir Chem Chemother. 2021 Jan-Dec;29:20402066211030380. doi: 10.1177/20402066211030380.'}, {'pmid': '24419064', 'type': 'DERIVED', 'citation': 'Gulick RM, Fatkenheuer G, Burnside R, Hardy WD, Nelson MR, Goodrich J, Mukwaya G, Portsmouth S, Heera JR. Five-year safety evaluation of maraviroc in HIV-1-infected treatment-experienced patients. J Acquir Immune Defic Syndr. 2014 Jan 1;65(1):78-81. doi: 10.1097/QAI.0b013e3182a7a97a.'}, {'pmid': '20703158', 'type': 'DERIVED', 'citation': 'Hardy WD, Gulick RM, Mayer H, Fatkenheuer G, Nelson M, Heera J, Rajicic N, Goodrich J. Two-year safety and virologic efficacy of maraviroc in treatment-experienced patients with CCR5-tropic HIV-1 infection: 96-week combined analysis of MOTIVATE 1 and 2. J Acquir Immune Defic Syndr. 2010 Dec 15;55(5):558-64. doi: 10.1097/QAI.0b013e3181ee3d82.'}, {'pmid': '18832245', 'type': 'DERIVED', 'citation': 'Fatkenheuer G, Nelson M, Lazzarin A, Konourina I, Hoepelman AI, Lampiris H, Hirschel B, Tebas P, Raffi F, Trottier B, Bellos N, Saag M, Cooper DA, Westby M, Tawadrous M, Sullivan JF, Ridgway C, Dunne MW, Felstead S, Mayer H, van der Ryst E; MOTIVATE 1 and MOTIVATE 2 Study Teams. Subgroup analyses of maraviroc in previously treated R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1442-55. doi: 10.1056/NEJMoa0803154.'}, {'pmid': '18832244', 'type': 'DERIVED', 'citation': 'Gulick RM, Lalezari J, Goodrich J, Clumeck N, DeJesus E, Horban A, Nadler J, Clotet B, Karlsson A, Wohlfeiler M, Montana JB, McHale M, Sullivan J, Ridgway C, Felstead S, Dunne MW, van der Ryst E, Mayer H; MOTIVATE Study Teams. Maraviroc for previously treated patients with R5 HIV-1 infection. N Engl J Med. 2008 Oct 2;359(14):1429-41. doi: 10.1056/NEJMoa0803152.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4001027&StudyName=Trial%20of%20Maraviroc%20%28UK-427%2C857%29%20in%20Combination%20with%20Optimized%20Background%20Therapy%20Versus%20Optimized%20Background%20Therapy%20Alone%20for%20the%20Tre', '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 purpose of this study is to evaluate the antiretroviral activity of maraviroc (UK-427,857) in HIV infected, treatment experienced patients who are failing their current antiretroviral regimen and are infected with R5-tropic virus exclusively. This study will involve more than 100 centers from the US and Canada to achieve a total randomized subject population of 500 subjects. Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \\[OBT (3-6 drugs based on treatment history and resistance testing)\\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment. This may be extended for an additional year depending on the results at 48 weeks. Physical examinations will be performed at study entry, weeks 4, 8, 12, 16, 20, 24, 32, 40, and 48. Blood samples will also be taken at study entry, weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48. Additionally, blood samples will be drawn twice, at least 30 minutes apart, at weeks 2 and 24 for maraviroc (UK-427,857) pharmacokinetic analysis. As part of this clinical study a blood sample will also be taken for non-anonymized pharmacogenetic analysis. Patients will undergo a 12-lead electrocardiogram at study entry, weeks 24 and 48.'}, '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 5,000 copies/mL\n* Stable pre-study antiretroviral regimen, or on no antiretroviral agents, for at least 4 weeks\n* Documented genotypic or phenotypic resistance to three of the four antiretroviral drug classes, OR, Antiretroviral-class experience greater than or equal to 6 months (sequential or cumulative) with at least three of the following: One nucleoside or nucleotide reverse transcriptase inhibitor, one non-nucleoside reverse transcriptase inhibitor, two protease inhibitors (excluding low-dose ritonavir) and/or enfuvirtide\n* Be willing to remain on randomized treatment without any changes or additions to the OBT regimen, except for toxicity management or upon meeting criteria for treatment failure\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* Patients requiring treatment with more than 6 antiretroviral agents (excluding low-dose ritonavir)\n* Prior treatment with maraviroc (UK-427,857) or another experimental HIV entry inhibitor for more than 14 days\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* Active alcohol or substance abuse sufficient, in the Investigator's judgement, to prevent adherence to study medication and/or follow up\n* Lactating women, or planned pregnancy during the trial period\n* Significant renal insufficiency\n* Previous therapy with a potentially myelosuppressive, neurotoxic, hepatoxic 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* Malignancy requiring parenteral chemotherapy that must be continued for the duration of the trial\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': 'NCT00098306', 'acronym': 'MOTIVATE 1', 'briefTitle': 'Trial of Maraviroc (UK-427,857) in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of HIV-1 Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of a Novel CCR5 Antagonist, UK-427,857, in Combination With Optimized Background Therapy Versus Optimized Background Therapy Alone for the Treatment of Antiretroviral-Experienced HIV-1 Infected Subjects.', 'orgStudyIdInfo': {'id': 'A4001027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: Maraviroc (UK-427,857)', 'Drug: Optimized Background Therapy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'interventionNames': ['Drug: Optimized Background Therapy', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '3', 'interventionNames': ['Drug: Optimized Background Therapy']}], 'interventions': [{'name': 'Maraviroc (UK-427,857)', 'type': 'DRUG', 'otherNames': ['Selzentry'], 'description': 'Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy', 'armGroupLabels': ['1']}, {'name': 'Optimized Background Therapy', 'type': 'DRUG', 'description': 'Maraviroc was given either once or twice per day with the dose adjusted according to the optimized background therapy', 'armGroupLabels': ['1']}, {'name': 'Optimized Background Therapy', 'type': 'DRUG', 'description': 'Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \\[OBT (3-6 drugs based on treatment history and resistance testing)\\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \\[OBT (3-6 drugs based on treatment history and resistance testing)\\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone.', 'armGroupLabels': ['2']}, {'name': 'Optimized Background Therapy', 'type': 'DRUG', 'description': 'Patients will be randomly (2:2:1) assigned to one of three groups: Optimized Background Therapy \\[OBT (3-6 drugs based on treatment history and resistance testing)\\] + maraviroc (UK-427,857) 150 mg taken once daily, OBT + maraviroc (UK-427,857) 150 mg taken twice daily, or OBT alone. The study will enroll over approximately a 9 month period with 48 weeks of treatment.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Auroa', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site'}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '20036', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33602', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32960', 'city': 'Vero Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 27.63864, 'lon': -80.39727}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '87505', 'city': 'Santa Fe', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 35.68698, 'lon': -105.9378}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '10467', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '45267-0405', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97219', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'H2L 4P9', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], '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'}}}}