Viewing Study NCT01229267

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Ignite Creation Date: 2025-12-25 @ 12:44 AM
Ignite Modification Date: 2025-12-25 @ 10:57 PM
Study NCT ID: NCT01229267
Status: COMPLETED
Last Update Posted: 2019-09-30
First Post: 2010-10-25
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Belgium', 'Brazil', 'Canada', 'Colombia', 'Croatia', 'Czechia', 'Ecuador', 'France', 'Germany', 'Israel', 'Italy', 'Lithuania', 'Mexico', 'Netherlands', 'Panama', 'Peru', 'Portugal', 'Puerto Rico', 'Russia', 'South Korea', 'Spain', 'Sweden', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006562', 'term': 'Herpes Zoster'}], 'ancestors': [{'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/ presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected up to approximately 5 years after vaccination 1.', 'description': 'The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'V212 [Including High Antigen Lot]', 'description': 'Participants received V212 Consistency Lot 1, 2, 3 or High Antigen Lot 0.5 mL administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.', 'otherNumAtRisk': 657, 'deathsNumAtRisk': 657, 'otherNumAffected': 625, 'seriousNumAtRisk': 657, 'deathsNumAffected': 136, 'seriousNumAffected': 420}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.', 'otherNumAtRisk': 554, 'deathsNumAtRisk': 554, 'otherNumAffected': 512, 'seriousNumAtRisk': 554, 'deathsNumAffected': 107, 'seriousNumAffected': 374}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 201, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 168, 'numAffected': 134}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 191, 'numAffected': 184}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 138, 'numAffected': 135}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 34, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 41, 'numAffected': 32}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 187, 'numAffected': 163}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 157, 'numAffected': 129}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 64, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 54, 'numAffected': 53}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 289, 'numAffected': 238}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 264, 'numAffected': 212}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 47, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 35, 'numAffected': 34}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 103, 'numAffected': 87}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 81, 'numAffected': 78}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 51, 'numAffected': 51}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 35, 'numAffected': 34}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 120, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 113, 'numAffected': 102}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 492, 'numAffected': 394}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 396, 'numAffected': 341}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 65, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 52, 'numAffected': 47}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 452, 'numAffected': 370}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 391, 'numAffected': 319}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 94, 'numAffected': 83}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 56, 'numAffected': 51}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 265, 'numAffected': 211}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 260, 'numAffected': 200}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 77, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 68, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 44, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 42, 'numAffected': 35}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 159, 'numAffected': 144}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 131, 'numAffected': 121}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 323, 'numAffected': 153}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 19, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 283, 'numAffected': 133}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 24, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 52, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 257, 'numAffected': 124}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mucosal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 271, 'numAffected': 254}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 244, 'numAffected': 226}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 89, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 72, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 526, 'numAffected': 317}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 374, 'numAffected': 248}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 161, 'numAffected': 152}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 150, 'numAffected': 132}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 40, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 65, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 45, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 165, 'numAffected': 141}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 135, 'numAffected': 111}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 88, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 75, 'numAffected': 62}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 48, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 42, 'numAffected': 40}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 63, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 51, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 35, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 46, 'numAffected': 44}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 51, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 28, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 149, 'numAffected': 131}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 141, 'numAffected': 114}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 38, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 32, 'numAffected': 31}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 91, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 71, 'numAffected': 68}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 84, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 93, 'numAffected': 80}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 60, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 36, 'numAffected': 36}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 48, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 78, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 48, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 31, 'numAffected': 22}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 72, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 45, 'numAffected': 38}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 110, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 84, 'numAffected': 74}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 38, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 64, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 52, 'numAffected': 48}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'seriousEvents': [{'term': 'Abdominal lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acquired haemophilia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaemia megaloblastic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 44, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 47, 'numAffected': 38}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Heparin-induced thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Immune thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Methaemoglobinaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Splenic infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypercalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lactose intolerance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tetany', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tumour lysis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cervical spinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intervertebral disc degeneration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pathological fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pseudarthrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Spinal column stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute myeloid leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute promyelocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Adenocarcinoma gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaplastic large cell lymphoma T- and null-cell types', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaplastic large cell lymphoma T- and null-cell types recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anaplastic large-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angiocentric lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Angioimmunoblastic T-cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'B-cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'B-cell lymphoma stage IV', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Basosquamous carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Bladder cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Breast cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Central nervous system lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic lymphocytic leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colon adenoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colon cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Colorectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diffuse large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diffuse large B-cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Diffuse large B-cell lymphoma refractory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Extranodal marginal zone B-cell lymphoma (MALT type) recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Follicle centre lymphoma, follicular grade I, II, III recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Hodgkin's disease nodular sclerosis", 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Hodgkin's disease recurrent", 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Langerhans' cell histiocytosis", 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lymphoplasmacytoid lymphoma/immunocytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malignant lymphoid neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mantle cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mantle cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metastases to meninges', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Neuroendocrine carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Non-Hodgkin's lymphoma", 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Non-Hodgkin's lymphoma recurrent", 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': "Non-Hodgkin's lymphoma refractory", 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nonkeratinising carcinoma of nasopharynx', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Paraneoplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pericardial effusion malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral T-cell lymphoma unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral T-cell lymphoma unspecified recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Plasma cell myeloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 75, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 57, 'numAffected': 51}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Plasma cell myeloma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 51, 'numAffected': 50}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 56, 'numAffected': 53}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Plasmablastic lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Plasmacytoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Precursor T-lymphoblastic lymphoma/leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Precursor T-lymphoblastic lymphoma/leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Primary mediastinal large B-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rectal cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rectal cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Small cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Squamous cell carcinoma of skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'T-cell lymphoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'T-cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tumour flare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Autonomic nervous system imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Carotid artery aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Carotid artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebellar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Facial paralysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoglycaemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Intracranial venous sinus thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Threatened labour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Disorientation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypomania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Schizoaffective disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute prerenal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'End stage renal disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Renal tubular necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Tubulointerstitial nephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acquired phimosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Idiopathic pneumonia syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung consolidation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Lung infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumomediastinum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Restrictive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Sleep apnoea syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Dermatitis exfoliative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Rash vesicular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Aortic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Peripheral artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Venoocclusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}, {'term': 'Venous thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 657, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 19.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Confirmed Herpes-Zoster', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V212 Consistency Lots', 'description': 'Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.889', 'groupId': 'OG000', 'lowerLimit': '23.703', 'upperLimit': '44.456'}, {'value': '91.883', 'groupId': 'OG001', 'lowerLimit': '75.725', 'upperLimit': '110.469'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.638', 'ciLowerLimit': '0.484', 'ciUpperLimit': '0.746', 'estimateComment': 'Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).', 'groupDescription': 'Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% confidence interval (CI) is \\>0.25.', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to approximately 5 years', 'description': 'Clinical criteria for suspected Herpes-Zoster (HZ) cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.', 'unitOfMeasure': 'Number of cases per 1000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.'}, {'type': 'SECONDARY', 'title': 'Incidence of Moderate to Severe Herpes-Zoster-Associated Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V212 Consistency Lots', 'description': 'Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.878', 'groupId': 'OG000', 'lowerLimit': '8.958', 'upperLimit': '23.234'}, {'value': '49.601', 'groupId': 'OG001', 'lowerLimit': '37.941', 'upperLimit': '63.714'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.695', 'ciLowerLimit': '0.490', 'ciUpperLimit': '0.818', 'estimateComment': 'Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).', 'groupDescription': 'Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \\>0.25.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months after onset of HZ (up to approximately 5 years)', 'description': 'Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.', 'unitOfMeasure': 'Number of cases per 1000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.'}, {'type': 'SECONDARY', 'title': 'Incidence of Herpes-Zoster Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V212 Consistency Lots', 'description': 'Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.397', 'groupId': 'OG000', 'lowerLimit': '4.855', 'upperLimit': '16.414'}, {'value': '35.777', 'groupId': 'OG001', 'lowerLimit': '25.996', 'upperLimit': '48.030'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.735', 'ciLowerLimit': '0.498', 'ciUpperLimit': '0.860', 'estimateComment': 'Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).', 'groupDescription': 'Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \\>0.25.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months after onset of HZ (up to approximately 5 years)', 'description': 'The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.', 'unitOfMeasure': 'Number of cases per 1000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.'}, {'type': 'SECONDARY', 'title': 'Incidence of Postherpetic Neuralgia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '538', 'groupId': 'OG000'}, {'value': '535', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V212 Consistency Lots', 'description': 'Participants randomized to receive V212 consistency Lot 1, 2, or 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.349', 'groupId': 'OG000', 'lowerLimit': '0.484', 'upperLimit': '6.865'}, {'value': '14.636', 'groupId': 'OG001', 'lowerLimit': '8.674', 'upperLimit': '23.132'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.837', 'ciLowerLimit': '0.446', 'ciUpperLimit': '0.952', 'estimateComment': 'Point estimate and 95% CI of vaccine efficacy were obtained from a Cox proportional hazards regression model, adjusting for age (\\<50 versus ≥50 years of age), and intended duration of antiviral prophylaxis (≤3 versus 3 to 6 months after auto-HCT).', 'groupDescription': 'Vaccine efficacy was calculated as 1 minus the hazard ratio of HZ in the V212 consistency lot group versus the placebo group. The success criterion for vaccine efficacy required that the lower bound of the 95% CI is \\>0.25.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 months after the onset of HZ rash (up to approximately 5 years)', 'description': 'Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with pain in the last 24 hours scored as 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset.', 'unitOfMeasure': 'Number of cases per 1000 person years', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included participants who received ≥1 dose and had auto-HCT. To comply with regulatory requests, results for the V212 consistency lots were combined for the efficacy analyses, and the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate efficacy estimates.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With One or More Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All V212 (Including High Antigen Lot)', 'description': 'V212 (all lots, including High Antigen Lot) administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000'}, {'value': '32.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.942', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.2', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '5.5', 'estimateComment': 'Miettinen \\& Nurminen', 'statisticalMethod': 'Normal approximation', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days after vaccination 4 (up to 118 days)', 'description': "An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}, {'value': '554', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'All V212 (Including High Antigen Lot)', 'description': 'V212 (all lots, including High Antigen Lot) administered by subcutaneous injection 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 28 days after vaccination 4 (up to 118 days)', 'description': "An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population included all participants who received ≥1 dose and had safety follow-up. To comply with regulatory requests, results for all lots of V212 were combined in the primary and secondary safety analyses. One participant randomized to placebo was cross-treated; this participant was excluded from the safety analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V212 Consistency Lot 1', 'description': 'Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'FG001', 'title': 'V212 Consistency Lot 2', 'description': 'Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'FG002', 'title': 'V212 Consistency Lot 3', 'description': 'Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'FG003', 'title': 'V212 High Antigen Lot', 'description': 'Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '189'}, {'groupId': 'FG001', 'numSubjects': '184'}, {'groupId': 'FG002', 'numSubjects': '187'}, {'groupId': 'FG003', 'numSubjects': '106'}, {'groupId': 'FG004', 'numSubjects': '564'}]}, {'type': 'Received Vaccination 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '180'}, {'groupId': 'FG002', 'numSubjects': '186'}, {'groupId': 'FG003', 'numSubjects': '104'}, {'groupId': 'FG004', 'numSubjects': '556'}]}, {'type': 'Received Vaccination 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '171'}, {'groupId': 'FG001', 'numSubjects': '163'}, {'groupId': 'FG002', 'numSubjects': '168'}, {'groupId': 'FG003', 'numSubjects': '94'}, {'groupId': 'FG004', 'numSubjects': '511'}]}, {'type': 'Received Vaccination 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '155'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '89'}, {'groupId': 'FG004', 'numSubjects': '491'}]}, {'type': 'Received Vaccination 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '155'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '149'}, {'groupId': 'FG003', 'numSubjects': '87'}, {'groupId': 'FG004', 'numSubjects': '477'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '102'}, {'groupId': 'FG002', 'numSubjects': '101'}, {'groupId': 'FG003', 'numSubjects': '71'}, {'groupId': 'FG004', 'numSubjects': '344'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '82'}, {'groupId': 'FG002', 'numSubjects': '86'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '220'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '10'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '103'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '32'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '59'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Progressive disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '25'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '22'}]}]}], 'recruitmentDetails': 'Adult participants scheduled to undergo Autologous Hematopoietic Cell Transplant (auto-HCT) within 60 days were enrolled at 150 sties', 'preAssignmentDetails': 'A total of 1323 participants were screened and 1257 were randomized. Twenty-seven randomized participants were removed from all analyses due to the identification of major Good Clinical Practice compliance issues at a single site.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'BG000'}, {'value': '184', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '564', 'groupId': 'BG004'}, {'value': '1230', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'V212 Consistency Lot 1', 'description': 'Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'BG001', 'title': 'V212 Consistency Lot 2', 'description': 'Participants randomized to receive V212 Consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'BG002', 'title': 'V212 Consistency Lot 3', 'description': 'Participants randomized to receive V212 Consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'BG003', 'title': 'V212 High Antigen Lot', 'description': 'Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'spread': '12.8', 'groupId': 'BG000'}, {'value': '54.2', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '53.4', 'spread': '12.4', 'groupId': 'BG002'}, {'value': '54.3', 'spread': '12.2', 'groupId': 'BG003'}, {'value': '54.1', 'spread': '12.2', 'groupId': 'BG004'}, {'value': '54.1', 'spread': '12.4', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '48', 'groupId': 'BG003'}, {'value': '204', 'groupId': 'BG004'}, {'value': '455', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '111', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}, {'value': '58', 'groupId': 'BG003'}, {'value': '360', 'groupId': 'BG004'}, {'value': '775', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age categorical', 'classes': [{'categories': [{'title': 'From 18-49 years', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '159', 'groupId': 'BG004'}, {'value': '346', 'groupId': 'BG005'}]}, {'title': 'From 50-59 years', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}, {'value': '40', 'groupId': 'BG003'}, {'value': '187', 'groupId': 'BG004'}, {'value': '407', 'groupId': 'BG005'}]}, {'title': 'From 60-69 years', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '188', 'groupId': 'BG004'}, {'value': '408', 'groupId': 'BG005'}]}, {'title': 'From 70-79 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '69', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Intended duration of antiviral prophylaxis', 'classes': [{'categories': [{'title': '≤3 months post auto-HCT', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '80', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '255', 'groupId': 'BG004'}, {'value': '537', 'groupId': 'BG005'}]}, {'title': '>3 to ≤6 months post auto-HCT', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}, {'value': '63', 'groupId': 'BG003'}, {'value': '308', 'groupId': 'BG004'}, {'value': '691', 'groupId': 'BG005'}]}, {'title': 'Not reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 1257 participants were enrolled. Twenty-seven participants were excluded from the analysis due to Good Clinical Practice non-compliance at a single site.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1257}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2015-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-10', 'studyFirstSubmitDate': '2010-10-25', 'resultsFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2010-10-26', 'lastUpdatePostDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-01', 'studyFirstPostDateStruct': {'date': '2010-10-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Study Medication Withdrawn Due to an Adverse Event', 'timeFrame': 'Up to 28 days after vaccination 4 (up to 118 days)', 'description': "An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event."}], 'primaryOutcomes': [{'measure': 'Incidence of Confirmed Herpes-Zoster', 'timeFrame': 'Up to approximately 5 years', 'description': 'Clinical criteria for suspected Herpes-Zoster (HZ) cases were the development of a papular or vesicular rash with a dermatomal or generalized distribution, or in the absence of a rash, clinical suspicion of VZV infection with or without the detection of VZV in diagnostic specimens from blood, cerebrospinal fluid, lung, liver, or other organ. All suspected cases of HZ were subjected to adjudication by the Clinical Adjudication Committee (CAC). Case confirmation was based on skin lesion polymerase chain reaction, if available, or by adjudication of the clinical case description by the CAC, conducted according to the CAC Standard Operations Procedure.'}, {'measure': 'Percentage of Participants With One or More Serious Adverse Events', 'timeFrame': 'Up to 28 days after vaccination 4 (up to 118 days)', 'description': "An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the sponsor's product, whether or not considered related to the use of the product. A serious adverse event (SAE) is an AE that results in death, is life threatening, results in a persistent or significant disability or incapacity, results in or prolongs an existing hospitalization, is a congenital anomaly or birth defect, is a cancer, is an overdose, or is another important medical event."}], 'secondaryOutcomes': [{'measure': 'Incidence of Moderate to Severe Herpes-Zoster-Associated Pain', 'timeFrame': 'Up to 6 months after onset of HZ (up to approximately 5 years)', 'description': 'Moderate to severe HZ-associated pain was defined as 2 or more occurrences of a score 3 or greater (0-to-10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the Zoster Brief Pain Inventory (ZBPI) at any time from HZ onset through the end of the 6 month HZ-follow-up period.'}, {'measure': 'Incidence of Herpes-Zoster Complications', 'timeFrame': 'Up to 6 months after onset of HZ (up to approximately 5 years)', 'description': 'The composite efficacy endpoint of the incidence of HZ complications was defined as the occurrence of any of the following during the study: hospitalization or prolongation of hospitalization due to HZ, disseminated HZ (including disseminated HZ rash or VZV viremia), visceral HZ, ophthalmic HZ, neurological impairment due to HZ, or administration of intravenous acyclovir therapy for treatment of HZ.'}, {'measure': 'Incidence of Postherpetic Neuralgia', 'timeFrame': 'Up to 6 months after the onset of HZ rash (up to approximately 5 years)', 'description': 'Postherpetic Neuralgia (PHN) was defined as pain in the area of the HZ rash with pain in the last 24 hours scored as 3 or greater (on a 0 to 10 scale, where 0 is no pain and 10 is pain as bad as you can imagine) on the ZBPI that persists or appears greater than or equal to 90 days after HZ rash onset.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Herpes zoster', 'vaccine', 'herpes zoster-related complications', 'immunocompromised', 'autologous hematopoietic cell transplants'], 'conditions': ['Herpes Zoster']}, 'referencesModule': {'references': [{'pmid': '32665955', 'type': 'DERIVED', 'citation': 'Boeckh MJ, Arvin AM, Mullane KM, Camacho LH, Winston DJ, Morrison VA, Hurtado K, Durrand Hall J, Pang L, Su SC, Kaplan SS, Annunziato PW, Popmihajlov Z; V212 Protocol 001 Trial Group and V212 Protocol 011 Trial Group. Immunogenicity of Inactivated Varicella Zoster Vaccine in Autologous Hematopoietic Stem Cell Transplant Recipients and Patients With Solid or Hematologic Cancer. Open Forum Infect Dis. 2020 Jun 2;7(7):ofaa172. doi: 10.1093/ofid/ofaa172. eCollection 2020 Jul.'}, {'pmid': '31721601', 'type': 'DERIVED', 'citation': 'Eriksson J, Hunger M, Bourhis F, Thoren R, Popmihajlov Z, Finelli L, Jiang Y. Cost and utility in immunocompromised subjects who developed herpes zoster during the randomized V212 inactivated varicella-zoster vaccine (ZVIN) trial. Expert Rev Pharmacoecon Outcomes Res. 2020 Dec;20(6):613-621. doi: 10.1080/14737167.2020.1693267. Epub 2019 Nov 18.'}, {'pmid': '29856344', 'type': 'DERIVED', 'citation': 'Winston DJ, Mullane KM, Cornely OA, Boeckh MJ, Brown JW, Pergam SA, Trociukas I, Zak P, Craig MD, Papanicolaou GA, Velez JD, Panse J, Hurtado K, Fernsler DA, Stek JE, Pang L, Su SC, Zhao Y, Chan ISF, Kaplan SS, Parrino J, Lee I, Popmihajlov Z, Annunziato PW, Arvin A; V212 Protocol 001 Trial Team. Inactivated varicella zoster vaccine in autologous haemopoietic stem-cell transplant recipients: an international, multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2018 May 26;391(10135):2116-2127. doi: 10.1016/S0140-6736(18)30631-7. Epub 2018 May 24.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled study to assess the safety and efficacy of inactivated VZV vaccine for the prevention of HZ and HZ-related complications in adult recipients of autologous hematopoietic cell transplants (HCTs). The primary hypothesis is that vaccination with V212 vaccine will reduce the incidence of herpes zoster (HZ) compared to placebo when administered to recipients of HCT. The statistical criterion for success requires that the lower bound of the 95% confidence interval for the estimated vaccine efficacy in the V212 recipients (excluding the high-antigen lot) compared with that in the placebo recipients is \\>25%.', 'detailedDescription': 'Study participants were randomized to receive one of 3 consistency lots of V212, a high antigen lot of V212, or placebo. To comply with regulatory requests, results for all lots of V212 were combined for the primary and secondary efficacy and safety evaluations (Protocol Amendment 2); all planned comparisons between the V212 lots were exploratory and are not included in this disclosure. Further, by regulatory request, the V212 High Antigen Lot was not included in the efficacy analyses for concerns that its inclusion would inflate the efficacy estimates (Protocol Amendment 4).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has prior history of varicella, antibodies to VZV (documented prior to receipt of blood products), or residence in a country with endemic VZV infection for ≥30 years or if participant is \\<30 years old, attended primary or secondary school in a country with endemic VZV infection.\n* Scheduled to undergo an autologous hematopoietic cell transplant within 60 days of enrollment\n* Is highly unlikely to conceive during the time period starting 2 weeks prior to enrollment through 6 months from last vaccination dose\n* Female participants of childbearing potential must have a negative serum or urine\n\npregnancy test.\n\nExclusion Criteria:\n\n* History of hypersensitivity reaction to any vaccine component\n* Prior history of herpes zoster within 1 year of enrollment\n* Prior receipt of any varicella or zoster vaccine\n* More than 2 relapses of the underlying cancer (participants with Hodgkin's lymphoma may have had more than 2 relapses)\n* Expectation of tandem transplant procedure\n* Is expected to receive \\>6 months (\\>180 days) of prophylactic antiviral therapy post-HCT.\n* Is pregnant or breastfeeding or expecting to conceive within the period of 2 weeks prior to enrollment through 6 months from last vaccination dose.\n* Has received a live virus vaccine or is scheduled to receive a live virus vaccine in the period from 4 weeks prior to Dose 1 through 28 days Postdose 4.\n* Has received an inactivated vaccine or is scheduled to receive an inactivated vaccine in the period between 7 days prior to and 28 days following Doses 1 through 4."}, 'identificationModule': {'nctId': 'NCT01229267', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Inactivated Varicella-zoster Vaccine (VZV) as a Preventative Treatment for Herpes Zoster (HZ) and HZ-related Complications in Participants Undergoing Hematopoietic Cell Transplants (HCTs) (V212-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Trial to Study the Safety, Tolerability, Efficacy, and Immunogenicity of V212 in Recipients of Autologous Hematopoietic Cell Transplants (HCTs)', 'orgStudyIdInfo': {'id': 'V212-001'}, 'secondaryIdInfos': [{'id': '2010-020150-34', 'type': 'EUDRACT_NUMBER'}, {'id': 'V212-001', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V212 Consistency Lot 1', 'description': 'Participants randomized to receive V212 consistency Lot 1 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.', 'interventionNames': ['Biological: V212']}, {'type': 'EXPERIMENTAL', 'label': 'V212 Consistency Lot 2', 'description': 'Participants randomized to receive V212 consistency Lot 2 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.', 'interventionNames': ['Biological: V212']}, {'type': 'EXPERIMENTAL', 'label': 'V212 Consistency Lot 3', 'description': 'Participants randomized to receive V212 consistency Lot 3 given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.', 'interventionNames': ['Biological: V212']}, {'type': 'EXPERIMENTAL', 'label': 'V212 High Antigen Lot', 'description': 'Participants randomized to receive V212 High Antigen Lot given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.', 'interventionNames': ['Biological: V212']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants randomized to receive matching placebo given as a 0.5 mL subcutaneous injection at 30 days before and 30, 60, and 90 days after auto-HCT.', 'interventionNames': ['Biological: Matching placebo']}], 'interventions': [{'name': 'V212', 'type': 'BIOLOGICAL', 'otherNames': ['Inactivated Varicella-Zoster (VZV) vaccine'], 'description': 'V212 viral antigen for HZ. Participants will receive consistency Lot 1, 2, or 3 or the High Antigen Lot.', 'armGroupLabels': ['V212 Consistency Lot 1', 'V212 Consistency Lot 2', 'V212 Consistency Lot 3', 'V212 High Antigen Lot']}, {'name': 'Matching placebo', 'type': 'BIOLOGICAL', 'description': 'Vaccine stabilizer for V212 with no virus antigen', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}