Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2026-04-02 @ 1:27 AM
Study NCT ID:
NCT03139604
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2017-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Hungary', 'Netherlands', 'Singapore', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718170', 'term': 'itacitinib'}, {'id': 'C000603457', 'term': 'INCB039110'}, {'id': 'D011241', 'term': 'Prednisone'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}], 'ancestors': [{'id': 'D011244', 'term': 'Pregnadienediols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medinfo@incyte.com', 'phone': '1-855-463-3463', 'title': 'Study Director', 'organization': 'Incyte Corporation'}, 'certainAgreement': {'otherDetails': 'Clinical Study Agreement', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days after last dose approximately up to 24 months', 'eventGroups': [{'id': 'EG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.', 'otherNumAtRisk': 215, 'deathsNumAtRisk': 215, 'otherNumAffected': 207, 'seriousNumAtRisk': 215, 'deathsNumAffected': 69, 'seriousNumAffected': 133}, {'id': 'EG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.', 'otherNumAtRisk': 216, 'deathsNumAtRisk': 216, 'otherNumAffected': 206, 'seriousNumAtRisk': 216, 'deathsNumAffected': 69, 'seriousNumAffected': 131}, {'id': 'EG002', 'title': 'Total', 'description': 'Total', 'otherNumAtRisk': 431, 'deathsNumAtRisk': 431, 'otherNumAffected': 413, 'seriousNumAtRisk': 431, 'deathsNumAffected': 138, 'seriousNumAffected': 264}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 32, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 28, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 60, 'numAffected': 52}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 36, 'numAffected': 32}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 39, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 62, 'numAffected': 51}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 80, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 66, 'numAffected': 54}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 146, 'numAffected': 117}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 43, 'numAffected': 41}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 37, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 18, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 55, 'numAffected': 36}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 15, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 34, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 25, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 45, 'numAffected': 38}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 33, 'numAffected': 28}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood cholesterol increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 19, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 32, 'numAffected': 27}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 47, 'numAffected': 44}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 22, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 49, 'numAffected': 46}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 35, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 54, 'numAffected': 42}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 89, 'numAffected': 74}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 61, 'numAffected': 50}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 38, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 30, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 68, 'numAffected': 60}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 52, 'numAffected': 47}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 48, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 60, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 108, 'numAffected': 85}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 43, 'numAffected': 40}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 37, 'numAffected': 35}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 24, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 39, 'numAffected': 32}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 31, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 50, 'numAffected': 43}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 26, 'numAffected': 25}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 23, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 45, 'numAffected': 41}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 32, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 54, 'numAffected': 37}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 86, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 19, 'numAffected': 18}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 39, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 60, 'numAffected': 52}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 56, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 57, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 113, 'numAffected': 97}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 23, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 34, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 52, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 35, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 87, 'numAffected': 77}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 33, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 34, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 67, 'numAffected': 58}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypoalbuminaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 39, 'numAffected': 35}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypocalcaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 21, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 38, 'numAffected': 36}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 51, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 43, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 94, 'numAffected': 75}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 46, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 74, 'numAffected': 48}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 27, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 27, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 54, 'numAffected': 38}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 31, 'numAffected': 25}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 23, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 49, 'numAffected': 47}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 24, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 20, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 44, 'numAffected': 42}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 47, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 45, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 92, 'numAffected': 71}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 57, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 59, 'numAffected': 40}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 116, 'numAffected': 76}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 55, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 61, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 116, 'numAffected': 106}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 28, 'numAffected': 27}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 45, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 70, 'numAffected': 60}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 24, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 38, 'numAffected': 30}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 44, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 38, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 82, 'numAffected': 65}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 87, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 77, 'numAffected': 69}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 164, 'numAffected': 142}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 28, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 21, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 49, 'numAffected': 46}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 25, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 44, 'numAffected': 34}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 19, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 34, 'numAffected': 32}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 53, 'numAffected': 48}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 30, 'numAffected': 30}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 22, 'numAffected': 18}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 23, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Epstein-Barr virus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 27, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 22, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neuropathy peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 17, 'numAffected': 17}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 21, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 18, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute graft versus host disease in skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 13, 'numAffected': 13}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Adenovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Angioedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Aspergillus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'BK virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood fibrinogen decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cachexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Campylobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebral toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cholecystitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Chronic lymphocytic leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Clostridium difficile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cystitis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cytomegalovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cytomegalovirus viraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 26, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diverticular perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Enterovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Epstein-Barr virus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Escherichia sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Extradural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 18, 'numAffected': 15}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastroenteritis norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Graft versus host disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Graft versus host disease in gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Graft versus host disease in lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haemoperitoneum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypercholesterolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypertriglyceridaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypofibrinogenaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Large intestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Limbic encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Liver function test increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Lower gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Lower respiratory tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Malnutrition', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Metabolic acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Microangiopathic haemolytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Mucormycosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myelodysplastic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myeloid leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nasal cavity cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neurotoxicity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neutropenic sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Obliterative bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ophthalmic herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Organising pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Peripheral motor neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pleuritic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumatosis intestinalis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia cytomegaloviral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia influenzal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia necrotising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonia pseudomonal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Post transplant lymphoproliferative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Posterior reversible encephalopathy syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pseudomonal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rash maculo-papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory tract infection fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Soft tissue necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Steroid diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Substance-induced psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'T-cell lymphoma recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Thrombotic microangiopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Toxic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Toxoplasmosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Varicella zoster virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Viral diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Viral haemorrhagic cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute graft versus host disease in intestine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Acute myeloid leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Adenoviral hepatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Agranulocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Altered state of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Amyotrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Anal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': "Bartter's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blast cell crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Blood bilirubin increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bone marrow failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Bullous oedema of the bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Clostridium test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Coronavirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Diabetic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Disseminated aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Electrocardiogram T wave abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Enterococcus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Epstein-Barr virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Fungal sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastrointestinal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haemolysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Intestinal ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Klebsiella sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Klebsiella test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Leukaemia recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Meningoencephalitis herpetic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pseudomonal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Rotavirus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sepsis syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sinusitis aspergillus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Sinusitis fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Spinal subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Streptococcal urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Toxicity to various agents', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Transaminases increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Transplant dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Transplant failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Ureterolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vascular device infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Venoocclusive liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 215, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 216, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 431, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000', 'lowerLimit': '67.6', 'upperLimit': '79.7'}, {'value': '66.4', 'groupId': 'OG001', 'lowerLimit': '59.7', 'upperLimit': '72.6'}]}]}], 'analyses': [{'pValue': '0.0782', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.45', 'ciLowerLimit': '0.959', 'ciUpperLimit': '2.204', 'pValueComment': 'Not adjusted for multiplicity with interim and final analyses', 'groupDescription': 'binomial distribution', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 28', 'description': 'Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Nonrelapse Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'title': '6 Months', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': '9 Months', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': '12 Months', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': '24 Months', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 6,9,12 and 24', 'description': 'Defined as the percentage of participants who died due to causes other than malignancy relapse.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Duration of Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '587', 'comment': 'Upper bound is not estimable', 'groupId': 'OG000', 'lowerLimit': '513', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Not Estimable', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months', 'description': 'Defined as the interval from first response until GVHD progression or death.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Cmax of Itacitinib When Administered in Combination With Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '796', 'spread': '642', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as maximum observed plasma concentration.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.'}, {'type': 'SECONDARY', 'title': 'Cmin of Itacitinib When Administered in Combination With Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'spread': '121', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as minimum observed plasma concentration.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7 as this is more representative of true steady state. Day 28 is positively biased as non responders are withdrawn from study by D28.'}, {'type': 'SECONDARY', 'title': 'Tmax of Itacitinib When Administered in Combination With Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '0.83', 'upperLimit': '5.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as time to maximum plasma concentration.', 'unitOfMeasure': 'hrs', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.'}, {'type': 'SECONDARY', 'title': 'AUC of Itacitinib When Administered in Combination With Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '6720', 'spread': '6210', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as area under the concentration-time curve.', 'unitOfMeasure': 'nM*h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.'}, {'type': 'SECONDARY', 'title': 'CL/F of Itacitinib When Administered in Combination With Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'spread': '76.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as oral dose clearance.', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who receive at least 1 dose of study drug and provide at least 1 plasma sample after study drug administration will be considered as potential PK evaluable subjects. The data presented is from Day 7.'}, {'type': 'SECONDARY', 'title': 'Time to Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '195', 'groupId': 'OG000'}, {'value': '185', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.9', 'spread': '6.25', 'groupId': 'OG000'}, {'value': '10.1', 'spread': '5.37', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of Study, total particpation expected to average 24 months', 'description': 'Defined as the interval from treatment initiation to first response', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population who were responders'}, {'type': 'SECONDARY', 'title': 'Relapse Rate of Malignant and Nonmalignant Hematologic Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of Study, study duration expected to average 24 months', 'description': 'Defined as the proportion of subjects whose underlying hematologic disease relapses', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Malignancy Relapse-related Mortality Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of Study, study duration expected to average 24 months', 'description': 'Defined as the proportion of subjects whose malignancy relapses and has a fatal outcome.', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Failure-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '44.29', 'groupId': 'OG000'}, {'value': '40.00', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months from randomization', 'description': 'Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD)', 'unitOfMeasure': 'proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '365', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '867'}, {'value': '348.5', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '827'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'End of Study up to approximately 24 months', 'description': 'Defined as the interval from study enrollment to death due to any cause.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-emergent Adverse Events With INCB39110', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '208', 'groupId': 'OG000'}, {'value': '214', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30-35 days after end of treatment, approximately 24 months', 'description': 'Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of Secondary Graft Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Randomization through end of Study, study duration expected to average 24 months', 'description': 'Defined as \\> 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (\\< 0.5 × 109/L) and/or thrombocytopenia (\\< 20 × 109/L) within 2 months of transplantion', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Who Discontinue Corticosteroids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '215', 'groupId': 'OG000'}, {'value': '216', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'title': 'Day 28', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Day 100', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}, {'title': 'Day 180', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 28, 56, 100, and 180', 'description': 'Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects Who Discontinue Immunosuppressive Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'title': 'Day 56', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Day 100', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 56 and 100', 'description': 'Summary statistics of subjects discontinuing immunosuppressive medications will be calculated', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of aGVHD Flares', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to day 100', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Incidence Rate of cGVHD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'title': 'Day 180', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Day 365', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 180 and 365', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}, {'type': 'SECONDARY', 'title': 'Objective Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}, {'value': '220', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'OG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'classes': [{'title': 'Day 14', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}]}]}, {'title': 'Day 56', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}]}, {'title': 'Day 100', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 14, 56 and 100', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS) Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'FG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Participants were considered to have completed the study if they dies or discontinued study treatment for any reason', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants were considered to have completed the study if they dies or discontinued study treatment for any reason', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '220'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '122'}, {'groupId': 'FG001', 'numSubjects': '127'}]}, {'type': 'Final EOS data missing due to COVID-19 restrictions that affected on-site monitoring', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 128 investigative sites in 19 different countries.', 'preAssignmentDetails': 'A total of 498 participants were screened for this study, of which 59 participants were screen failures and 439 participants were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '439', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Itacitinib Plus Corticosteroids', 'description': 'Itacitinib was administered at a starting dose of 200 mg orally once daily QD (2 × 100 mg tablets) in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'BG001', 'title': 'Placebo Plus Corticosteroids', 'description': 'Matching placebo was administered orally once daily QD in combination with steroids i.e. methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of the disease.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '13.53', 'groupId': 'BG000'}, {'value': '54.0', 'spread': '12.96', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '13.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '129', 'groupId': 'BG001'}, {'value': '266', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '169', 'groupId': 'BG001'}, {'value': '336', 'groupId': 'BG002'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '194', 'groupId': 'BG001'}, {'value': '390', 'groupId': 'BG002'}]}]}, {'title': 'Black/African-American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'American-Indian/Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-13', 'size': 3772579, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-01T14:19', 'hasProtocol': True}, {'date': '2019-07-23', 'size': 803178, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-01T14:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 439}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-28', 'studyFirstSubmitDate': '2017-05-02', 'resultsFirstSubmitDate': '2020-05-01', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2020-05-01', 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Response Rate Based on Center for International Blood and Marrow Transplant Research (CIBMTR) Response Index', 'timeFrame': 'Day 28', 'description': 'Defined as the percentage of participants demonstrating a complete response (CR), very good partial response (VGPR), or partial response (PR).'}], 'secondaryOutcomes': [{'measure': 'Nonrelapse Mortality', 'timeFrame': 'Month 6,9,12 and 24', 'description': 'Defined as the percentage of participants who died due to causes other than malignancy relapse.'}, {'measure': 'Duration of Response', 'timeFrame': 'Baseline through 30-35 days after end of treatment, total particpation expected to average 24 months', 'description': 'Defined as the interval from first response until GVHD progression or death.'}, {'measure': 'Cmax of Itacitinib When Administered in Combination With Corticosteroids', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as maximum observed plasma concentration.'}, {'measure': 'Cmin of Itacitinib When Administered in Combination With Corticosteroids', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as minimum observed plasma concentration.'}, {'measure': 'Tmax of Itacitinib When Administered in Combination With Corticosteroids', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as time to maximum plasma concentration.'}, {'measure': 'AUC of Itacitinib When Administered in Combination With Corticosteroids', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as area under the concentration-time curve.'}, {'measure': 'CL/F of Itacitinib When Administered in Combination With Corticosteroids', 'timeFrame': 'Protocol-defined timepoints up to Day 28', 'description': 'Defined as oral dose clearance.'}, {'measure': 'Time to Response', 'timeFrame': 'End of Study, total particpation expected to average 24 months', 'description': 'Defined as the interval from treatment initiation to first response'}, {'measure': 'Relapse Rate of Malignant and Nonmalignant Hematologic Disease', 'timeFrame': 'Randomization through end of Study, study duration expected to average 24 months', 'description': 'Defined as the proportion of subjects whose underlying hematologic disease relapses'}, {'measure': 'Malignancy Relapse-related Mortality Rate', 'timeFrame': 'Randomization through end of Study, study duration expected to average 24 months', 'description': 'Defined as the proportion of subjects whose malignancy relapses and has a fatal outcome.'}, {'measure': 'Failure-free Survival', 'timeFrame': '6 months from randomization', 'description': 'Defined as the proportion of subjects who are still alive, have not relapsed, have not required additional therapy for aGVHD, and have not demonstrated signs or symptoms of chronic graft-versus-host disease (cGVHD)'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'End of Study up to approximately 24 months', 'description': 'Defined as the interval from study enrollment to death due to any cause.'}, {'measure': 'Number of Treatment-emergent Adverse Events With INCB39110', 'timeFrame': '30-35 days after end of treatment, approximately 24 months', 'description': 'Adverse events reported for the first time or worsening of a pre-existing event after the first dose of study treatment'}, {'measure': 'Incidence Rate of Secondary Graft Failure', 'timeFrame': 'Randomization through end of Study, study duration expected to average 24 months', 'description': 'Defined as \\> 95% recipient cells any time after engraftment with no signs of relapse, OR retransplantation because of secondary neutropenia (\\< 0.5 × 109/L) and/or thrombocytopenia (\\< 20 × 109/L) within 2 months of transplantion'}, {'measure': 'Proportion of Subjects Who Discontinue Corticosteroids', 'timeFrame': 'Days 28, 56, 100, and 180', 'description': 'Average and cumulative corticosteroid dose usage will be calculated and proportion of subjects discontinuing corticosteroids will be tabulated'}, {'measure': 'Proportion of Subjects Who Discontinue Immunosuppressive Medications', 'timeFrame': 'Days 56 and 100', 'description': 'Summary statistics of subjects discontinuing immunosuppressive medications will be calculated'}, {'measure': 'Incidence Rate of aGVHD Flares', 'timeFrame': 'up to day 100'}, {'measure': 'Incidence Rate of cGVHD', 'timeFrame': 'Days 180 and 365'}, {'measure': 'Objective Response Rate', 'timeFrame': 'Days 14, 56 and 100'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute graft-versus-host disease', 'Janus kinase (JAK) inhibitor', 'itacitinib', 'corticosteroids', 'allogeneic hematopoietic stem cell transplant (allo-HSCT)'], 'conditions': ['Graft-versus-host Disease (GVHD)']}, 'referencesModule': {'references': [{'pmid': '35689489', 'type': 'DERIVED', 'citation': 'Pratta M, Paczesny S, Socie G, Barkey N, Liu H, Owens S, Arbushites MC, Schroeder MA, Howell MD. A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease. Br J Haematol. 2022 Aug;198(4):729-739. doi: 10.1111/bjh.18300. Epub 2022 Jun 11.'}, {'pmid': '34971577', 'type': 'DERIVED', 'citation': 'Zeiser R, Socie G, Schroeder MA, Abhyankar S, Vaz CP, Kwon M, Clausen J, Volodin L, Giebel S, Chacon MJ, Meyers G, Ghosh M, Deeren D, Sanz J, Morariu-Zamfir R, Arbushites M, Lakshminarayanan M, Barbour AM, Chen YB. Efficacy and safety of itacitinib versus placebo in combination with corticosteroids for initial treatment of acute graft-versus-host disease (GRAVITAS-301): a randomised, multicentre, double-blind, phase 3 trial. Lancet Haematol. 2022 Jan;9(1):e14-e25. doi: 10.1016/S2352-3026(21)00367-7.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate itacitinib or placebo in combination with corticosteroids as first-line treatment of participants with Grade II to IV acute graft-versus-host disease (aGVHD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Has undergone 1 allo-HSCT from any donor (related or unrelated with any degree of HLA matching) and any donor source (bone marrow, peripheral blood stem cells, or cord blood) for a hematologic malignancy or disorder. Recipients of myeloablative and reduced-intensity conditioning regimens are eligible.\n* Clinically suspected Grade II to IV aGVHD as per MAGIC criteria, occurring after allo-HSCT and any GVHD prophylaxis regimen.\n* Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.\n* Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockroft Gault equation.\n* Willing to avoid pregnancy or fathering children.\n* Able to give written informed consent and comply with all study visits and procedures.\n* Able to swallow and retain oral medication.\n\nExclusion Criteria:\n\n* Has received more than 1 allo-HSCT.\n* Has received more than 2 days of systemic corticosteroids for aGVHD.\n* Presence of GVHD overlap syndrome.\n* Presence of an active uncontrolled infection.\n* Known human immunodeficiency virus infection.\n* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation.\n* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.\n* Any corticosteroid therapy for indications other than GVHD at doses \\> 1 mg/kg per day methylprednisolone (or prednisone equivalent) within 7 days of randomization.\n* Severe organ dysfunction unrelated to underlying GVHD, including:\n\n * Cholestatic disorders or unresolved veno-occlusive disease of the liver.\n * Clinically significant or uncontrolled cardiac disease.\n * Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen.\n* Currently breast feeding.\n* Received JAK inhibitor therapy after allo-HSCT for any indication. Treatment with a JAK inhibitor before allo-HSCT is permitted.\n* Treatment with any other investigational agent, device, or procedure within 21 days (or 5 half-lives, whichever is greater) of enrollment.\n* Any medical complications or conditions that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.\n* Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds."}, 'identificationModule': {'nctId': 'NCT03139604', 'briefTitle': 'GRAVITAS-301: A Study of Itacitinib or Placebo in Combination With Corticosteroids for Treatment of Acute Graft-Versus-Host Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Incyte Corporation'}, 'officialTitle': 'GRAVITAS-301: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Itacitinib or Placebo in Combination With Corticosteroids for the Treatment of First-Line Acute Graft-Versus-Host Disease', 'orgStudyIdInfo': {'id': 'INCB 39110-301'}, 'secondaryIdInfos': [{'id': '2017-000538-78', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Itacitinib', 'description': 'Itacitinib plus corticosteroids', 'interventionNames': ['Drug: Itacitinib', 'Drug: Prednisone', 'Drug: Methylprednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching placebo plus corticosteroids', 'interventionNames': ['Drug: Placebo', 'Drug: Prednisone', 'Drug: Methylprednisolone']}], 'interventions': [{'name': 'Itacitinib', 'type': 'DRUG', 'otherNames': ['INCB039110'], 'description': 'Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.', 'armGroupLabels': ['Itacitinib']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo tablets administered orally once daily (QD) plus corticosteroids.', 'armGroupLabels': ['Placebo']}, {'name': 'Prednisone', 'type': 'DRUG', 'otherNames': ['Deltasone', 'Prednicot', 'predniSONE Intensol', 'Rayos', 'Sterapred', 'Sterapred DS'], 'description': "Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.", 'armGroupLabels': ['Itacitinib', 'Placebo']}, {'name': 'Methylprednisolone', 'type': 'DRUG', 'otherNames': ['Medrol', 'Medrol Dosepak', 'Solu-Medrol'], 'description': 'Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.', 'armGroupLabels': ['Itacitinib', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093-0698', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego (UCSD) - Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90095-1678', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Los Angeles (UCLA) - Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Cancer Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Aurora Cancer Center', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida (UF) - Division of Hematology & Oncology', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami - Sylvester Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60028', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': 'Advocate Lutheran General Hospital - Oncology Specialists SC', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University (IU) Melvin and Bren Simon Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46237', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Blood and Marrow Transplant', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Spectrum Health', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198-7680', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'John Theurer Cancer Center At Hackensack UMC', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '08903-2681', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'Stony Brook University Medical Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center - Wake Forest University School of Medicine', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45236', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oncology Hematology in Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University (OSU)', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma - Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University (OHSU)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Greenville Health System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Methodist Healthcare Foundation', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute, LLC (SCRI)', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Transplant Institute', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': 'NSW 2010', 'city': 'Darlinghurst', 'country': 'Australia', 'facility': 'St Vincents Hospital Sydney Limited', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '4020', 'city': 'Linz', 'country': 'Austria', 'facility': 'Ordensklinikum Linz GmbH Elisabethinen', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '2060', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Stuivenberg', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'General Hospital Sint-Jan Brugge-Oostend', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent (UZG)', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Hopital universitaire du Sart Tilman de Liege', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'zip': '128 20', 'city': 'Prague', 'country': 'Czechia', 'facility': 'UHKT Prague - Institute of Hematology and Blood Transfusion', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '00290', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki University Central Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens Picardie - Hopital Sud', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU de Lille-Hopital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Hotel Dieu Hospital - Hematologie', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '33604', 'city': 'Pessac', 'country': 'France', 'facility': 'Hopital Haut Leveque - CHU Bordeaux - Maladies du sang', 'geoPoint': {'lat': 44.80565, 'lon': -0.6324}}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hopital de Hautepierre', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud-Universitaire du Cancer Toulouse Oncopol', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '50924', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitaet zu Koln - Universitaetsklinikum Koeln (Uniklinik Koeln)', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '1307', 'city': 'Dresden', 'country': 'Germany', 'facility': 'University Clinic Carl Gustav Carus, Technical University Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Universitatsklinikum Freiburg - Klinik fur Innere Medizin I', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitatsklinikum Hamburg - Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '4103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Universitaetsklinikum Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Universitaetsmedizin der Johannes Gutenberg', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '35043', 'city': 'Marburg', 'country': 'Germany', 'facility': 'UKGM Marburg Innere Medizin: Haematologie Onkolog', 'geoPoint': {'lat': 50.80904, 'lon': 8.77069}}, {'zip': '57010', 'city': 'Chortiatis', 'country': 'Greece', 'facility': 'General Hospital of Thessaloniki G. Papanikolaou - Hematology Department', 'geoPoint': {'lat': 40.60954, 'lon': 23.10014}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Health Care Campus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '9112001', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Hebrew University Medical Center Ein Karem', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '5262160', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '09126', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'C.T.M.O. Ospedale Roberto Binaghi ATS Cagliari', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '95124', 'city': 'Catania', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria (AOU) Policlinico - Vittorio Emanuele - Presidio Ospedaliero Ferrarotto Alessi', 'geoPoint': {'lat': 37.49223, 'lon': 15.07041}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliero Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'IRCCS Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'ASST Grande Ospedale Metropolitano Niguarda', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20900', 'city': 'Monza', 'country': 'Italy', 'facility': 'Clinica Ematologica CTA, Ospedale "San Gerardo" di Monza', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'zip': '90146', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Casa di Cura La Maddalena', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione IRCCS Policlinco San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '65124', 'city': 'Pescara', 'country': 'Italy', 'facility': 'Presidio Ospedaliero Pescara', 'geoPoint': {'lat': 42.4584, 'lon': 14.20283}}, {'zip': '89124', 'city': 'Reggio Calabria', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Bianchi-Melacrino-Morelli Ospedali Riuniti', 'geoPoint': {'lat': 38.11047, 'lon': 15.66129}}, {'zip': '42123', 'city': 'Reggio Emilia', 'country': 'Italy', 'facility': 'Azienda Unità Sanitaria Locale di Reggio Emilia', 'geoPoint': {'lat': 44.69825, 'lon': 10.63125}}, {'zip': '00161', 'city': 'Roma', 'country': 'Italy', 'facility': 'University of Rome La Sapienza', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '20089', 'city': 'Rozzano', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '10126', 'city': 'Torino', 'country': 'Italy', 'facility': 'A.O.U. Città della Salute e della Scienza di Torino', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '33100', 'city': 'Udine', 'country': 'Italy', 'facility': 'SOC Clinica Ematologica, Azienda Ospediero-Universitaria di Udine', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'zip': '1023', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland District Health Board', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '44-101', 'city': 'Gliwice', 'country': 'Poland', 'facility': 'Centrum Onkologii- Instytut w Gliwicach', 'geoPoint': {'lat': 50.29761, 'lon': 18.67658}}, {'zip': '02-776', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Klinika Transplantacji Komorek Krwiotworczych - Instytut Hematologii i Transfuzjologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '1099-023', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Instituto Portugues de Oncologia de Lisboa Francisco Gentil EPE (IPO-Lisboa)', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649-035', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar Lisboa Norte - Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4200-072', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '3080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital de la Santa Creu i Sant Pau - Servei de Hematologia Clinica', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitario Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Instituto Catalan de Oncologia - Hospital Duran i Reynals', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Complejo Hospitalario Universitario de Granada - Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Maranon', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Ramon y Cajal', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28222', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario Puerta de Hierro Majadahonda', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '37007', 'city': 'Salamanca', 'country': 'Spain', 'facility': 'Hospital Universitario de Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}, {'zip': '20014', 'city': 'San Sebastián', 'country': 'Spain', 'facility': 'Hospital Universitario de Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'zip': '39008', 'city': 'Santander', 'country': 'Spain', 'facility': 'Hospital Universitario Marques de Valdecilla', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'Hospital Clinico de Santiago de Compostela', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '41013', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen del Rocio', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '46010', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clinico Universitario de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universtity Hospital Basel - Haematology', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hopitaux Universitaires de Geneve', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'CH-8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Universitaetsspital Zuerich - Klinik fuer Haematology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '40447 ROC', 'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'W12 0HS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Rodica Morariu-Zamfir, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Incyte Corporation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Incyte Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}