Ignite Creation Date:
2025-12-24 @ 4:38 PM
Ignite Modification Date:
2026-01-18 @ 10:55 PM
Study NCT ID:
NCT00865566
Status:
TERMINATED
Last Update Posted:
2021-10-15
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000257', 'term': 'Adenoviridae 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'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jandries@fredhutch.org', 'phone': '206-667-5812', 'title': 'Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations', 'organization': 'Fred Hutchinson Cancer Research Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Reporting of all AEs occurred during 2 periods for each participant: 1) from enrollment through 28 days after the third vaccination, and 2) from the fourth vaccination through 28 days after the fourth vaccination. Between and after these time periods, only SAEs, new chronic conditions requiring medical intervention of more than 30 days, and newly diagnosed/treated STIs were reported. Events requiring expedited reporting (protocol section 12.3) were reported through the study, up to 60 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid', 'otherNumAtRisk': 1253, 'deathsNumAtRisk': 1253, 'otherNumAffected': 833, 'seriousNumAtRisk': 1253, 'deathsNumAffected': 1, 'seriousNumAffected': 77}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid', 'otherNumAtRisk': 1251, 'deathsNumAtRisk': 1251, 'otherNumAffected': 828, 'seriousNumAtRisk': 1251, 'deathsNumAffected': 11, 'seriousNumAffected': 95}], 'otherEvents': [{'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphatic system disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaemias NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leukocytoses NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Red blood cell abnormal findings NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Spleen disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Supraventricular arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rate and rhythm disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Male reproductive tract disorders congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 7}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ear disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Inner ear signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'External ear disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Middle ear disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Eustachian tube disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hearing losses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tympanic membrane disorders (excl infections)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thyroid hypofunction disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Endocrine abnormalities of gonadal function NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Male gonadal function disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thyroid hyperfunction disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 11}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lid, lash and lacrimal infections, irritations and inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ocular disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Conjunctival and corneal bleeding and vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ocular sensation disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Visual disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Conjunctival infections, irritations and inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Eyelid movement disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lacrimation disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ocular infections, inflammations and associated manifestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Blindness (excl colour blindness)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Glaucomas (excl congenital)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Refractive and accommodative disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Retinal, choroid and vitreous infections and inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 149}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 146}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diarrhoea (excl infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 53}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nausea and vomiting symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal and abdominal pains (excl oral and throat)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stomatitis and ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal atonic and hypomotility disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemorrhoids and gastrointestinal varices (excl oesophageal)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anal and rectal disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dental pain and sensation disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dyspeptic signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intestinal haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastritis (excl infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis (excl infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-site specific gastrointestinal haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal hernias NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anal and rectal signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dental and periodontal infections and inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diaphragmatic hernias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Flatulence, bloating and distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gingival disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gingival haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oesophageal ulcers and perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tongue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tongue signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Benign neoplasms gastrointestinal (excl oral cavity)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal inflammatory disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral dryness and saliva altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal findings abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anal and rectal pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dental disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Faecal abnormalities NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal dyskinetic disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal fistulae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Inguinal hernias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oral soft tissue pain and paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peptic ulcers and perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rectal inflammations NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 138}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 104}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Injection site reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Asthenic conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Febrile disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Feelings and sensations NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'General signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain and discomfort NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Administration site reactions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oedema NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Therapeutic and nontherapeutic responses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaccination site reactions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mass conditions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Withdrawal and rebound effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hepatocellular damage and hepatitis NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholecystitis and cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cholestasis and jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hepatobiliary signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 14}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Atopic disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 7}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Allergies to foods, food additives, drugs and other chemicals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Allergic conditions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaphylactic and anaphylactoid responses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 531}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 549}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 275}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 254}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neisseria infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 83}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Viral infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 72}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chlamydial infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 72}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Treponema infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal and gastrointestinal infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Herpes viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 30}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Streptococcal infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 31}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lower respiratory tract and lung infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Papilloma viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bacterial infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Eye and eyelid infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin structures and soft tissue infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dental and oral soft tissue infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ectoparasitic infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ear infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Staphylococcal infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tinea infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Influenza viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Male reproductive tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fungal infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hepatitis viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Candida infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Molluscum contagiosum viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Epstein-Barr viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Giardia infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tuberculous infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Amoebic infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bone and joint infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Caliciviral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Clostridia infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coxsackie viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cytomegaloviral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Escherichia infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemophilus infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Helicobacter infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nematode infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 108}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 101}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 20}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle, tendon and ligament injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 23}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-site specific injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 9}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-site specific procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Limb fractures and dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Site specific injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 8}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neurological and psychiatric procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bone and joint injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thermal burns', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 7}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Exposures to agents or circumstances NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Radiation injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebral injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fractures and dislocations NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Eye injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skull fractures, facial bone fractures and dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thoracic cage fractures and dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Chest and lung injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal and hepatobiliary procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ear injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Overdoses NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Poisoning and toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Reproductive system and breast injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Spinal fractures and dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vaccination related complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 63}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vascular tests NEC (incl blood pressure)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 47}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Reproductive hormone analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Liver function analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Red blood cell analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Carbohydrate tolerance analyses (incl diabetes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Digestive enzymes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mineral and electrolyte analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Platelet analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bacteria identification and serology (excl mycobacteria)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac auscultatory investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coagulation and bleeding analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Heart rate and pulse investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Investigations NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Musculoskeletal and soft tissue tests NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mycobacteria identification and serology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tissue enzyme analyses NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'White blood cell analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 20}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Diabetes mellitus (incl subtypes)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fat soluble vitamin deficiencies and disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Appetite disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Elevated cholesterol', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Disorders of purine metabolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'General nutritional disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Potassium imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fluid intake increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Food malabsorption and intolerance syndromes (excl sugar intolerance)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lipid metabolism and deposit disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Water soluble vitamin deficiencies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Elevated triglycerides', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperlipidaemias NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hypoglycaemic conditions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Magnesium metabolism disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Protein metabolism disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sugar intolerance (excl glucose intolerance)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Total fluid volume decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 107}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Musculoskeletal and connective tissue pain and discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 49}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle pains', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Joint related signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 19}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle related signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Tendon disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bone related signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Arthropathies NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bone disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bursal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intervertebral disc disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle weakness conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle tone abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cartilage disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Extremity deformities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Joint related disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Musculoskeletal and connective tissue infections and inflammations NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Osteoarthropathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rheumatoid arthropathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Soft tissue disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Synovial disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 17}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin neoplasms benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 14}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lip and oral cavity neoplasms benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin neoplasms malignant and unspecified (excl melanoma)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Soft tissue neoplasms benign NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nervous system neoplasms benign NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Reproductive neoplasms male benign NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 103}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 88}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Headaches NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 41}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neurological signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paraesthesias and dysaesthesias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 11}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Migraine headaches', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sensory abnormalities NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Disturbances in consciousness NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mononeuropathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral neuropathies NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lumbar spinal cord and nerve root disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Narcolepsy and hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Seizures and seizure disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cervical spinal cord and nerve root disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coordination and balance disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Disturbances in sleep phase rhythm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Facial cranial nerve disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Memory loss (excl dementia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mental impairment (excl dementia and memory loss)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neurologic visual problems NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sleep disturbances NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 65}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Depressive disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anxiety symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 17}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Disturbances in initiating and maintaining sleep', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 12}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Substance related and addictive disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Attention deficit and disruptive behaviour disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anxiety disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bipolar disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Panic attacks and disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sexual desire disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Stress disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Emotional and mood disturbances NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Schizophrenia NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Behaviour and socialisation disturbances', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fear symptoms and phobic disorders (incl social phobia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Fluctuating mood symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mental disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mood alterations with depressive symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mood disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Schizoaffective and schizophreniform disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sleep disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Somatic symptom disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Suicidal and self-injurious behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 23}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bladder and urethral symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal lithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urethral disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bladder neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 26}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Penile disorders NEC (excl erection and ejaculation)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 7}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Reproductive tract signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Erection and ejaculation conditions and disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Prostate and seminal vesicles infections and inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Reproductive tract disorders NEC (excl neoplasms)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Testicular and epididymal disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Scrotal disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pelvic prolapse conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sexual function and fertility disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Spermatogenesis and semen disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Testicular and epididymal neoplasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 123}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 95}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract signs and symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coughing and associated symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasal congestion and inflammations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 17}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Paranasal sinus disorders (excl infections and neoplasms)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bronchospasm and obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pharyngeal disorders (excl infections and neoplasms)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breathing abnormalities', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Nasal disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory tract disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Laryngeal and adjacent sites disorders NEC (excl infections and neoplasms)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pulmonary oedemas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Respiratory failures (excl neonatal)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 112}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 86}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dermatitis and eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 17}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rashes, eruptions and exanthems NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Apocrine and eccrine gland disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dermal and epidermal conditions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 11}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pruritus NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 8}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Erythemas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Psoriatic conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acnes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Angioedemas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bullous conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Papulosquamous conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pilar disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Purpura and related conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin and subcutaneous tissue ulcerations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin cysts and polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin preneoplastic conditions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Alopecias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Dermatitis ascribed to specific agent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperkeratoses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Hyperpigmentation disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Photosensitivity and photodermatosis conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rosaceas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Crime victims', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 49}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vascular hypertensive disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 42}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral vascular disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemorrhages NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lymphoedemas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral embolism and thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'seriousEvents': [{'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anaemias NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ischaemic coronary artery disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Coronary artery disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Heart failures NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Supraventricular arrhythmias', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Ventricular arrhythmias and cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Haemoglobinopathies congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colitis (excl infective)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute and chronic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Duodenal ulcers and perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intestinal ulcers and perforation NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal hernias NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastric ulcers and perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal atonic and hypomotility disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastrointestinal stenosis and obstruction NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-site specific gastrointestinal haemorrhages', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Oesophageal ulcers and perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Rectal inflammations NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pain and discomfort NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Death and sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Withdrawal and rebound effects', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Acute and chronic sarcoidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Allergies to foods, food additives, drugs and other chemicals', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal and gastrointestinal infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bacterial infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Lower respiratory tract and lung infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Upper respiratory tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Clostridia infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Sepsis, bacteraemia, viraemia and fungaemia NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin structures and soft tissue infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Staphylococcal infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Streptococcal infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bone and joint infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Borrelial infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Breast infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Herpes viral infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Infectious disorders carrier', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Urinary tract infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Viral infections NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Limb fractures and dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skull fractures, facial bone fractures and dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-site specific injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Overdoses NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Poisoning and toxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Site specific injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Spinal fractures and dislocations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Abdominal injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiac and vascular procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cardiovascular injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Cerebral injuries NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle, tendon and ligament injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pathways and sources of exposure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thermal burns', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Liver function analyses', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Metabolism tests NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Potassium imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bursal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Intervertebral disc disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Muscle weakness conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Myopathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Prostatic neoplasms malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Colorectal neoplasms malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Gastric neoplasms malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Leukaemias acute lymphocytic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Testicular neoplasms malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Thyroid neoplasms malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Seizures and seizure disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Central nervous system haemorrhages and cerebrovascular accidents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Encephalopathies NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mononeuropathies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Neurological signs and symptoms NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Optic nerve disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Transient cerebrovascular events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Device malfunction events NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 22}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Suicidal and self-injurious behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 11}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Depressive disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Substance related and addictive disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Bipolar disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Anxiety symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Psychotic disorder NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Confusion and disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Mental disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Schizoaffective and schizophreniform disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Schizophrenia NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Somatic symptom disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal failure and impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Renal lithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Testicular and epididymal disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pulmonary thrombotic and embolic conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Pneumothorax and pleural effusions NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Skin and subcutaneous tissue ulcerations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Any event in SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Peripheral embolism and thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Non-site specific necrosis and vascular insufficiency NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vascular hypertensive disorders NEC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}, {'term': 'Vascular hypotensive disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1253, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1251, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participant Dropout Through Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1251', 'groupId': 'OG000'}, {'value': '1245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'classes': [{'categories': [{'measurements': [{'value': '340', 'groupId': 'OG000'}, {'value': '436', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.73', 'ciLowerLimit': '0.63', 'ciUpperLimit': '0.84', 'estimateComment': 'HR is vaccine / placebo', 'groupDescription': 'Cox proportional hazards model to assess the association between treatment assignment and dropout', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Score test'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment through Month 48 visit', 'description': 'For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population'}, {'type': 'PRIMARY', 'title': 'Participant Dropout Prior to Unblinding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1251', 'groupId': 'OG000'}, {'value': '1245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'classes': [{'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.59', 'ciUpperLimit': '1', 'pValueComment': 'Score test', 'estimateComment': 'HR is vaccine / placebo', 'groupDescription': 'Cox PH model to assess the association between treatment assignment and dropout', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)', 'description': 'The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.\n\nFor participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population'}, {'type': 'PRIMARY', 'title': 'Participant Dropout After Unblinding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}, {'value': '999', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'classes': [{'categories': [{'measurements': [{'value': '241', 'groupId': 'OG000'}, {'value': '309', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.84', 'pValueComment': 'Score test', 'estimateComment': 'HR is vaccine / placebo', 'groupDescription': 'Assess the association between treatment assignment and dropout', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'April 23, 2013 through trial closure (up to Month 48 visit)', 'description': 'The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.\n\nFor participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT population participants who were HIV-uninfected and on-study as of April 23, 2013'}, {'type': 'PRIMARY', 'title': 'HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1251', 'groupId': 'OG000'}, {'value': '1245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.903', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.42', 'pValueComment': 'Score test', 'estimateComment': 'HR is vaccine / placebo', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for age, behavioral risk score, square of behavioral risk score, race, and BMI'}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment through Month 48 visit', 'description': 'For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Cohort'}, {'type': 'PRIMARY', 'title': 'HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1251', 'groupId': 'OG000'}, {'value': '1245', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.783', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.71', 'ciUpperLimit': '1.58', 'pValueComment': 'Adjusted for ave, behavioral risk score, square of behavioral risk score, and BMI', 'estimateComment': 'HR is vaccine / placebo', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Score test'}], 'paramType': 'NUMBER', 'timeFrame': 'Enrollment through Month 24 visit', 'description': 'For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat Cohort'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1253', 'groupId': 'OG000'}, {'value': '1251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '415', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '723', 'groupId': 'OG000'}, {'value': '744', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '370', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Potentially life-threatening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination', 'description': 'For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled Participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1253', 'groupId': 'OG000'}, {'value': '1251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '717', 'groupId': 'OG000'}, {'value': '980', 'groupId': 'OG001'}]}, {'title': '>0 to 25 square cm', 'measurements': [{'value': '498', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}, {'title': '>25 to 81 square cm (grade 1)', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': '>9 cm any diameter (grade 2)', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': '>81 square cm (grade 2)', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination', 'description': 'For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}, {'type': 'PRIMARY', 'title': 'Number of Participants Experiencing Systemic Reactogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1253', 'groupId': 'OG000'}, {'value': '1251', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'classes': [{'categories': [{'title': 'None', 'measurements': [{'value': '563', 'groupId': 'OG000'}, {'value': '667', 'groupId': 'OG001'}]}, {'title': 'Mild', 'measurements': [{'value': '408', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}]}, {'title': 'Moderate', 'measurements': [{'value': '240', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}, {'title': 'Severe', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Potentially life-threatening', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination', 'description': 'For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Enrollment is defined as receiving the first vaccination.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1253'}, {'groupId': 'FG001', 'numSubjects': '1251'}]}, {'type': 'Modified Intent-to-Treat Population', 'comment': 'Participants excluded from MITT if HIV-1 positive at first vaccination (retrospective testing)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1251'}, {'groupId': 'FG001', 'numSubjects': '1245'}]}, {'type': 'COMPLETED', 'comment': 'Completed if attended all visits. Note dropout endpoint does NOT include all visits.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '629'}, {'groupId': 'FG001', 'numSubjects': '564'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '624'}, {'groupId': 'FG001', 'numSubjects': '687'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '314'}, {'groupId': 'FG001', 'numSubjects': '315'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '65'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Participant relocated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '78'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'Participant unable to adhere', 'reasons': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Other; N=245 due to early study closure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '139'}]}, {'type': 'HIV infection', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1253', 'groupId': 'BG000'}, {'value': '1251', 'groupId': 'BG001'}, {'value': '2504', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Vaccine', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA plasmid vaccine: 4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid\n\nRecombinant adenoviral serotype 5 (rAD5) vector vaccine: 1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.\n\nDNA vaccine placebo: 1 mL IM via Biojector® in either deltoid\n\nHIV-1 recombinant adenovirus vaccine placebo: 1 mL administered IM by needle and syringe in either deltoid'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '50'}, {'value': '30', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '50'}, {'value': '29', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '50'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '18-20 years', 'categories': [{'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '213', 'groupId': 'BG002'}]}]}, {'title': '21-30 years', 'categories': [{'measurements': [{'value': '585', 'groupId': 'BG000'}, {'value': '569', 'groupId': 'BG001'}, {'value': '1154', 'groupId': 'BG002'}]}]}, {'title': '31-40 years', 'categories': [{'measurements': [{'value': '299', 'groupId': 'BG000'}, {'value': '299', 'groupId': 'BG001'}, {'value': '598', 'groupId': 'BG002'}]}]}, {'title': '41-50 years', 'categories': [{'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '275', 'groupId': 'BG001'}, {'value': '539', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '1231', 'groupId': 'BG000'}, {'value': '1229', 'groupId': 'BG001'}, {'value': '2460', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Transgender Male', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Transgender Female', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported gender identity', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1253', 'groupId': 'BG000'}, {'value': '1251', 'groupId': 'BG001'}, {'value': '2504', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '219', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1128', 'groupId': 'BG000'}, {'value': '1157', 'groupId': 'BG001'}, {'value': '2285', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '222', 'groupId': 'BG000'}, {'value': '204', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '939', 'groupId': 'BG000'}, {'value': '944', 'groupId': 'BG001'}, {'value': '1883', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '91', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': '<18.5 kg/m^2', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}, {'title': '18.5-24.9 kg/m^2', 'categories': [{'measurements': [{'value': '550', 'groupId': 'BG000'}, {'value': '586', 'groupId': 'BG001'}, {'value': '1136', 'groupId': 'BG002'}]}]}, {'title': '25.0-29.9 kg/m^2', 'categories': [{'measurements': [{'value': '391', 'groupId': 'BG000'}, {'value': '381', 'groupId': 'BG001'}, {'value': '772', 'groupId': 'BG002'}]}]}, {'title': '30.0-34.9 kg/m^2', 'categories': [{'measurements': [{'value': '189', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '356', 'groupId': 'BG002'}]}]}, {'title': '35-39.9 kg/m^2', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': '>=40 kg/m^2', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}, {'title': 'Missing/Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of male sexual partners within 3 months prior to screening assessment', 'classes': [{'categories': [{'title': '0', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}, {'title': '1', 'measurements': [{'value': '256', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '499', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '253', 'groupId': 'BG000'}, {'value': '242', 'groupId': 'BG001'}, {'value': '495', 'groupId': 'BG002'}]}, {'title': '3-4', 'measurements': [{'value': '349', 'groupId': 'BG000'}, {'value': '367', 'groupId': 'BG001'}, {'value': '716', 'groupId': 'BG002'}]}, {'title': '5 or more', 'measurements': [{'value': '330', 'groupId': 'BG000'}, {'value': '327', 'groupId': 'BG001'}, {'value': '657', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of male sexual partners within 3 months prior to screening assessment', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '125'}, {'value': '3', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '70'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '125'}]}]}], 'paramType': 'MEDIAN', 'description': 'Self-reported at screening', 'unitOfMeasure': 'partners', 'dispersionType': 'FULL_RANGE'}, {'title': 'Any unprotected receptive anal sex with a partner within 3 months prior to screening assessment', 'classes': [{'categories': [{'measurements': [{'value': '589', 'groupId': 'BG000'}, {'value': '573', 'groupId': 'BG001'}, {'value': '1162', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Self-reported at screening', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All Enrolled Participants'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2014-07-21', 'size': 1606319, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-10-08T12:18', 'hasProtocol': True}, {'date': '2014-10-03', 'size': 121828, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-10-08T12:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2504}}, 'statusModule': {'whyStopped': 'The trial was stopped for efficacy futility', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2009-03-17', 'resultsFirstSubmitDate': '2018-10-08', 'studyFirstSubmitQcDate': '2009-03-18', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-01', 'studyFirstPostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participant Dropout Through Month 48', 'timeFrame': 'Enrollment through Month 48 visit', 'description': 'For participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.'}, {'measure': 'Participant Dropout Prior to Unblinding', 'timeFrame': 'Enrollment until the date of dropout, through April 22, 2013 (up to Month 24 visit)', 'description': 'The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.\n\nFor participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.'}, {'measure': 'Participant Dropout After Unblinding', 'timeFrame': 'April 23, 2013 through trial closure (up to Month 48 visit)', 'description': 'The trial was unblinded on April 23, 2013, and the protocol was in version 4 at the time.\n\nFor participants remaining uninfected, dropout is assessed only for primary follow-up, i.e. clinic visits. Protocol versions 4 and earlier included 24 months of primary follow-up, and versions 5 and later included 48 months. Participants may terminate early after completing primary follow-up, and participants who were found to be HIV-1 infected are analyzed as non-dropouts, so the number of dropouts and number of early terminations need not match.'}, {'measure': 'HIV-1 Infections Diagnosed After Day 0 Including All Available Follow-up Through the Maximum Month 48 Visit', 'timeFrame': 'Enrollment through Month 48 visit', 'description': 'For time-to-event analysis, an event is defined as HIV-1 infection and participants are censored if they dropped out early or completed the trial. HIV-1 diagnosis date is defined as the date of the earliest specimen collection yielding a positive HIV test. Participants remaining uninfected were censored at the latest specimen collection with a negative HIV-1 test.'}, {'measure': 'HIV-1 Infections Diagnosed After Day 0 Through the Month 24 Visit', 'timeFrame': 'Enrollment through Month 24 visit', 'description': 'For time-to-event analysis, an event is defined as HIV-1 infection and participants remaining uninfected through the month 24 visit were censored. HIV-1 diagnosis date is defined as the date of the earliest specimen collection at or prior to month 24 which yielded a positive HIV test. Participants remaining uninfected through the month 24 visit were censored at the latest specimen collection with a negative HIV-1 test at or prior to the month 24 visit.'}, {'measure': 'Number of Participants Experiencing Local Reactogenicity: Pain and/or Tenderness', 'timeFrame': 'Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination', 'description': 'For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.'}, {'measure': 'Number of Participants Experiencing Local Reactogenicity: Erythema and/or Induration', 'timeFrame': 'Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination', 'description': 'For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Local reactogenicity parameters are pain, tenderness, erythema, and induration. We present the maximum grade for pain and/or tenderness, and erythema and/or induration.'}, {'measure': 'Number of Participants Experiencing Systemic Reactogenicity', 'timeFrame': 'Through 3 days post each study vaccination, and to resolution for events present at the third day post vaccination', 'description': 'For each sign or symptom, we define the maximum observed grade for each participant over all vaccinations and post-vaccination assessments. Local and systemic signs and symptoms are assessed and graded based on The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), Version 1.0, December, 2004 (Clarification dated August 2009). Systemic reactogenicity parameters are malaise/fatigue, myalgia, headache, nausea, vomiting, chills, and arthralgia. We present the maximum grade calculated over these parameters.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV Seronegativity', 'HIV Preventive Vaccine', 'HIV Treatment Vaccine', 'Adenovirus'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '18443427', 'type': 'BACKGROUND', 'citation': 'Lu S. Immunogenicity of DNA vaccines in humans: it takes two to tango. Hum Vaccin. 2008 Nov-Dec;4(6):449-52. doi: 10.4161/hv.4.6.6179. Epub 2008 Nov 28.'}, {'pmid': '19031031', 'type': 'BACKGROUND', 'citation': 'Patterson S, Papagatsias T, Benlahrech A. Use of adenovirus in vaccines for HIV. Handb Exp Pharmacol. 2009;(188):275-93. doi: 10.1007/978-3-540-71029-5_13.'}, {'pmid': '20636279', 'type': 'RESULT', 'citation': 'Benmira S, Bhattacharya V, Schmid ML. An effective HIV vaccine: A combination of humoral and cellular immunity? Curr HIV Res. 2010 Sep;8(6):441-9. doi: 10.2174/157016210793499286.'}, {'pmid': '24099601', 'type': 'DERIVED', 'citation': 'Hammer SM, Sobieszczyk ME, Janes H, Karuna ST, Mulligan MJ, Grove D, Koblin BA, Buchbinder SP, Keefer MC, Tomaras GD, Frahm N, Hural J, Anude C, Graham BS, Enama ME, Adams E, DeJesus E, Novak RM, Frank I, Bentley C, Ramirez S, Fu R, Koup RA, Mascola JR, Nabel GJ, Montefiori DC, Kublin J, McElrath MJ, Corey L, Gilbert PB; HVTN 505 Study Team. Efficacy trial of a DNA/rAd5 HIV-1 preventive vaccine. N Engl J Med. 2013 Nov 28;369(22):2083-92. doi: 10.1056/NEJMoa1310566. Epub 2013 Oct 7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, circumcised men and male-to-female (MTF) transgender persons who have sex with men.\n\nNOTES:\n\nAs of April 2013, all vaccinations in this study have been stopped.\n\nAs of June 2017, this study has been closed.', 'detailedDescription': 'In 2007, the Joint United Nations Programme on HIV/AIDS estimated that 33.2 million people were living with HIV/AIDS globally. The U.S. HIV prevalence data reported in October 2008 by the Centers for Disease Control and Prevention estimate that 1.1 million adults and adolescents were living with diagnosed or undiagnosed HIV infection in the United States at the end of 2006. Nearly half of all U.S. HIV infections (48.1%) were found in men who have sex with men (MSM). Given the difficulty of maintaining behaviors that prevent HIV transmission over a lifetime and the occurrence of nonconsensual sex, the need for a safe and effective vaccine is clear. The primary purpose of this study is to determine the safety and efficacy of a VRC DNA/rAd5 vaccine regimen in healthy, at-risk, circumcised men and MTF transgender persons who have sex with men.\n\nParticipants will be randomly assigned to one of two arms. Participants in Arm 1 will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. Participants in Arm 2 will receive placebo injections at study entry and on Days 28, 56, and 168.\n\nParticipants who do not become HIV infected will be actively followed for a minimum of 24 months and will continue to be followed by the study for long-term safety surveillance for a total of 5 years following enrollment. Participants will be contacted annually during the period of long-term safety surveillance.\n\nParticipants who are found to be HIV infected prior to receiving their first injection or who receive their first injection but were HIV infected prior to study start will be followed on a modified schedule.\n\nParticipants who become HIV infected will be followed for 6 months post-diagnosis.\n\nAt most study visits, participants will undergo a physical exam and blood draw.\n\nNOTES:\n\nAs of April 2013, all vaccinations in this study have been stopped. Participants have been notified of whether they received the study vaccines or placebo. Participants diagnosed with HIV infection will attend study visits for 6 months for health monitoring. Participants who are not diagnosed with HIV infection will attend planned study visits for 24 months and will be followed by the study clinic at least annually for a total of 5 years following study enrollment.\n\nAs of June 2017, this study has been closed. Therefore, to avoid further burden on study participants, further participant follow-up for the study is suspended.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HIV-1 and -2 negative\n* Good general health\n* Fully circumcised\n* Experienced one or both of the following HIV risk criteria in the 6 months before study entry:\n\n 1. Unprotected anal intercourse with one or more male or MTF transgender partner(s)\n 2. Anal intercourse with two or more male or MTF transgender partners\n* Alanine aminotransferase (ALT) 2.5 or less times the upper limit of normal (ULN)\n* Ad5 neutralizing antibody (nAb) titer less than 1:18\n* Have access to a participating study site and are willing to be followed during the study\n* Demonstrate understanding of the study\n* Willing to receive HIV test results\n* Willing to discuss HIV infection risks and amenable to risk-reduction counseling\n* Agrees not to enroll in another study of an investigational research agent before unblinding of this study\n* NOTE: MTF transgender volunteers who have undergone gender reassignment surgery (GRS) are eligible to participate if they provide documentation from a health care provider confirming that they were fully circumcised prior to GRS. MTF transgender volunteers who have not undergone GRS are eligible to participate if they meet all enrollment criteria. Receipt of hormonal therapy does not make a transgender volunteer ineligible.\n\nExclusion Criteria:\n\n* HIV vaccines in prior HIV vaccine trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.\n* Used antiretroviral (ARV) drugs for the purpose of HIV-1 prophylaxis for greater than or equal to 50% of days during the 3 months prior to first vaccination or for 30 consecutive days within the 60 days prior to first vaccination\n* Circumcised within 90 days prior to first vaccination or displays evidence that surgical site is not fully healed\n* Immunosuppressive medications within 168 days prior to first study vaccination. Participants who have used corticosteroid nasal sprays for allergic rhinitis; topical corticosteroids for mild, uncomplicated dermatitis; or oral/parenteral corticosteroids for nonchronic conditions are not excluded.\n* Blood products within 90 days prior to first study vaccination\n* Immunoglobulin within 90 days prior to first study vaccination\n* Live attenuated vaccines other than influenza vaccine within 30 days prior to first study vaccination\n* Investigational research agents within 90 days prior to first study vaccination\n* Influenza vaccine or any vaccines that are not live attenuated within 14 days prior to first study vaccination\n* Allergy treatment with antigen injections within 30 days prior to first study vaccination or that are scheduled within 14 days after first vaccination\n* Clinically significant medical condition, physical examination findings, abnormal laboratory results, or past medical history that, in the judgment of the investigator, has significant implications for current health\n* Any medical, psychiatric, or job-related responsibility that would interfere with the study. More information about this criterion can be found in the protocol.\n* Any concern that, in the opinion of the investigator, may interfere with a participant's completion of the post-vaccination symptom log\n* History of serious adverse reactions to vaccinations, including anaphylaxis or allergy to any of the vaccine's components\n* Current anti-tuberculosis prophylaxis or therapy\n* Autoimmune disease. People with mild, stable, and uncomplicated autoimmune disease that does not require immunosuppressive medication and that, in the judgment of the site investigator, is likely not subject to exacerbation and likely not to complicate reactogenicity and adverse event assessments are not excluded.\n* Immunodeficiency\n* Bleeding disorder\n* History of malignancy\n* Seizure disorder. People with a history of seizures who have had no seizures within the 3 years prior to study entry are not excluded.\n* Asthma other than mild, well-controlled asthma\n* Hereditary angioedema (HAE), acquired angioedema (AAE), or idiopathic angioedema"}, 'identificationModule': {'nctId': 'NCT00865566', 'briefTitle': 'Safety and Effectiveness of HIV-1 DNA Plasmid Vaccine and HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Circumcised Men and Male-to-Female (MTF) Transgender Persons Who Have Sex With Men', 'nctIdAliases': ['NCT00919789'], 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Phase 2b, Randomized, Placebo-Controlled Test-of-Concept Trial to Evaluate the Safety and Efficacy of a Multiclade HIV-1 DNA Plasmid Vaccine Followed by a Multiclade HIV-1 Recombinant Adenoviral Vector Vaccine in HIV-Uninfected, Adenovirus Type 5 Neutralizing Antibody Negative, Circumcised Men and Male-to-Female (MTF) Transgender Persons, Who Have Sex With Men', 'orgStudyIdInfo': {'id': 'HVTN 505'}, 'secondaryIdInfos': [{'id': '10753', 'type': 'REGISTRY', 'domain': 'DAIDS ES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Participants will receive a recombinant DNA plasmid vaccine injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.', 'interventionNames': ['Biological: DNA plasmid vaccine', 'Biological: Recombinant adenoviral serotype 5 (rAD5) vector vaccine']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Participants will receive a recombinant DNA plasmid vaccine placebo injection at study entry and on Days 28 and 56, followed by a recombinant adenoviral serotype vector vaccine placebo injection on Day 168. As of April 2013, all vaccinations in this study have been stopped.', 'interventionNames': ['Biological: DNA vaccine placebo', 'Biological: HIV-1 recombinant adenovirus vaccine placebo']}], 'interventions': [{'name': 'DNA plasmid vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['VRC-HIVDNA016-00-VP'], 'description': '4-mg injection administered as 1 mL intramuscularly (IM) via Biojector® in either deltoid', 'armGroupLabels': ['1']}, {'name': 'Recombinant adenoviral serotype 5 (rAD5) vector vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['VRC-HIVADV014-00-VP'], 'description': '1 x 10\\^10 particle units (PU) administered as 1mL IM by needle and syringe in either deltoid', 'armGroupLabels': ['1']}, {'name': 'DNA vaccine placebo', 'type': 'BIOLOGICAL', 'otherNames': ['VRC-PBSPLA043-00-VP', 'phosphate buffered saline (PBS)'], 'description': '1 mL IM via Biojector® in either deltoid', 'armGroupLabels': ['2']}, {'name': 'HIV-1 recombinant adenovirus vaccine placebo', 'type': 'BIOLOGICAL', 'otherNames': ['VRC-DILUENT013-DIL-VP', 'final formulation buffer (FFB)'], 'description': '1 mL administered IM by needle and syringe in either deltoid', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama CRS', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90015', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'The AIDS Research Alliance of America CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90035', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA CARE Center CRS', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Bridge HIV CRS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital CRS', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Immunology Center CRS', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Hope Clinic of the Emory Vaccine Center CRS', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'UIC Project WISH CRS', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '20816', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'VRC Clinical Trials Core CRS', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02115-6110', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital Vaccine CRS (BWH VCRS)", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215-4302', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Fenway Health (FH) CRS', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Univ. HIV/AIDS CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032-3732', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia P&S CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Blood Center CRS', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Vaccines to Prevent HIV Infection CRS', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Clinical Research Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Prevention CRS', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232-2582', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Vaccine (VV) CRS', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern CRS', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Vaccine Research Center CRS', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22003', 'city': 'Annandale', 'state': 'Virginia', 'country': 'United States', 'facility': 'Care-Id Crs', 'geoPoint': {'lat': 38.83039, 'lon': -77.19637}}, {'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Vaccine and Prevention CRS', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Scott Hammer', 'role': 'STUDY_CHAIR', 'affiliation': 'Columbia University'}, {'name': 'Magdalena Sobieszczyk', 'role': 'STUDY_CHAIR', 'affiliation': 'Columbia University'}, {'name': 'Michael Yin', 'role': 'STUDY_CHAIR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'HIV Vaccine Trials Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}