Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-28 @ 2:03 PM
Study NCT ID:
NCT03059992
Status:
COMPLETED
Last Update Posted:
2024-11-20
First Post:
2017-02-14
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'id': 'D002178', 'term': 'Candidiasis, Chronic Mucocutaneous'}, {'id': 'D003047', 'term': 'Coccidioidomycosis'}, {'id': 'D006660', 'term': 'Histoplasmosis'}, {'id': 'D001759', 'term': 'Blastomycosis'}, {'id': 'D001229', 'term': 'Aspergillosis, Allergic Bronchopulmonary'}, {'id': 'D055744', 'term': 'Invasive Pulmonary Aspergillosis'}, {'id': 'D002181', 'term': 'Candidiasis, Vulvovaginal'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014848', 'term': 'Vulvovaginitis'}, {'id': 'D014627', 'term': 'Vaginitis'}, {'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014847', 'term': 'Vulvitis'}, {'id': 'D014845', 'term': 'Vulvar Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C569338', 'term': 'ibrexafungerp'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.angulo@scynexis.com', 'phone': '201-884-5471', 'title': 'Dr. David Angulo, SCYNEXIS CEO', 'organization': 'SCYNEXIS, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.', 'eventGroups': [{'id': 'EG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.\n\nIbrexafungerp: Experimental Study Drug', 'otherNumAtRisk': 233, 'deathsNumAtRisk': 233, 'otherNumAffected': 215, 'seriousNumAtRisk': 233, 'deathsNumAffected': 15, 'seriousNumAffected': 102}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 163}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 111}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 92}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 22}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 20}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 38}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 17}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 12}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 13}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numAffected': 16}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'Abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acinetobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute lymphocytic leukaemia refractory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthritis bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Atypical pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'B-cell type acute leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Blastic plasmacytoid dendritic cell neoplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myelosuppression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bronchopulmonary aspergillosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bronchopulmonary aspergillosis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Candida infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cardiac failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cytomegalovirus infection reactivation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Deafness neurosensory', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Device dislocation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Disease progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Drug clearance decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Enterobacter bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Enterobacter pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Enterococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Escherichia bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Escherichia infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Extradural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Facial bones fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrointestinal anastomotic leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrointestinal anastomotic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'General physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Graft versus host disease in gastrointestinal tract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'HCoV-NL63 infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hepatic enzyme increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hospitalisation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypocalcaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypovolaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intertrigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intervertebral discitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Joint effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Kidney rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Klebsiella bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Mycobacterium avium complex infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Osteonecrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancreatic pseudocyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pelvic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pericarditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia klebsiella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pneumonia 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'Pseudomonas infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Psoas abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pulmonary vein stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 233, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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'OG000'}]}]}, {'title': 'Acute Invasive Candidiasis including Candidemia (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '40', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Acute Invasive Candidiasis including Candidemia (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '37', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Invasive Candidiasis (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Invasive Candidiasis (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Esophageal Candidiasis (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Esophageal Candidiasis (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Oropharyngeal Candidiasis (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Oropharyngeal Candidiasis (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Mucocutaneous Candidiasis (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Mucocutaneous Candidiasis (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vulvovaginal Candidiasis (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Vulvovaginal Candidiasis (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '24', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Disseminated/Invasive Dimorphic Fungi (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Disseminated/Invasive Dimorphic Fungi (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Pulmonary Aspergillosis (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Pulmonary Aspergillosis (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Allergic Bronchopulmonary Aspergillosis (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Allergic Bronchopulmonary Aspergillosis (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Pulmonary Aspergillosis (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Pulmonary Aspergillosis (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other Emerging Fungi (ITT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other Emerging Fungi (PP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological).\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug.\n\nPer Protocol (PP) Population - include all ITT participants who received enough study drug to enable clinical efficacy judgement as determined by the DRC, who have an EOT or TOC (as applicable) assessment and who have no major protocol violations that could impact the assessment of efficacy.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Refractory Fungal Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '74', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '41', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Resistance to standard of care antifungal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '95', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}, {'title': 'Intolerance to standard of care antifungal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Toxicities associated with standard of care antifungal', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological).\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Invasive Candidiasis including Candidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '52', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Dimorphic Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Other emerging fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological).\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population - all participants who were enrolled in the study and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Invasive Candidiasis including Candidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '57', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (TOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Dimorphic Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Other emerging fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) .\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Invasive Candidiasis, including Candidemia (C. albicans)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. auris)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. glabrata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. krusei)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. parapsilosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. tropicalis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. albicans)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. glabrata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. krusei)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. tropicalis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. parapsilosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Dimorphic Fungi (Histoplasmosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes (A. flavus)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes (A. fumigatus)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes (other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) .\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Acute Invasive Candidiasis, including Candidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '30', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Invasive Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '27', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vulvovaginal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Esophageal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Oropharyngeal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Mucocutaneous Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Disseminated/Invasive Dimorphic Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Allergic Bronchopulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other Emerging Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) .\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Refractory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '57', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}, {'title': 'Resistence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '75', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '23', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '25', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Intolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Response', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) .\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Mycological Response by Disease Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Invasive Candidiasis including Candidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (TOC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Dimorphic Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Other emerging fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Mycological Response by Disease Category and Pathogen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Invasive Candidiasis, including Candidemia (C. albicans)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. parapsilosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. auris)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. glabrata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. krusei)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (C. tropicalis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Candidiasis, including Candidemia (other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. albicans)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. glabrata)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. krusei)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. parapsilosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis (C. tropicalis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mucocutaneous Candidiasis other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Dimorphic Fungi (Coccidioidomycosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Dimorphic Fungi (Histoplasmosis)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes (A. nidulans)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes (A. fumigatus)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes (A. flavus)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Aspergillus Syndromes (other)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Mycological Response by Fungal Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Acute Invasive Candidiasis, including Candidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Invasive Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}, {'title': 'Esophageal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Oropharyngeal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Mucocutaneous Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Vulvovaginal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Disseminated/Invasive Dimorphic Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Allergic Bronchopulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}, {'title': 'Other Emerging Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Missing', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Mycological Response by Enrollment Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Refractory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '33', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Failure', 'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Resistence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '28', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Failure', 'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'Intolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Failure', 'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Toxicities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Failure', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Success', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Failure', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable/Failure', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) includes all participants enrolled in the study who received at lease one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Recurrence of Baseline Fungal Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Acute Invasive Candidiasis including Candidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '35', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Invasive Candidasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '29', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Candidemia only', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Esophageal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Oropharyngeal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Mucotaneous Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Vulvovaginal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '18', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Disseminated/Invasive Dimorphic Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Allergic Bronchopulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Recurrence', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No Recurrence', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Not Evaluable', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '42 days for vulvovaginal candidiasis and 6 weeks after End of Treatment (up to 180 days after treatment start) for all other diseases.', 'description': 'The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) population (any participant who was enrolled in the study and received at least one dose of study drug) that achieved a Global Response.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Surviving at Day 30 or Day 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Acute Invasive Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '39', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Invasive Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '43', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Candidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Esophageal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Oropharyngeal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '14', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Mucocutaneous Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Vulvovaginal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '32', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Disseminated/Invasive Dimorphic Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Chronic Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Allergic Bronchopulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Invasive Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '22', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Other Emerging Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Alive', 'measurements': [{'value': '10', 'groupId': 'OG000'}]}, {'title': 'Dead', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases.', 'description': 'Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat (ITT) Population - any participant enrolled in the study who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Time to Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Acute Invasive Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Candidemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Chronic Invasive Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Vulvovaginal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Esophageal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Oropharyngeal Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '122', 'upperLimit': 'NA'}]}]}, {'title': 'Chronic Mucocutaneous Candidiasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Diffuse/Invasive Dimorphic Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Chronic Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '125', 'upperLimit': 'NA'}]}]}, {'title': 'Allergic Bronchopulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Invasive Pulmonary Aspergillosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '282', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '282', 'upperLimit': 'NA'}]}]}, {'title': 'Other Emerging Fungi', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '270', 'comment': 'Not Evaluable: Insufficient number of participants with events', 'groupId': 'OG000', 'lowerLimit': '270', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.', 'description': 'Time to death from any cause in days per Fungal Disease', 'unitOfMeasure': 'Number of days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population - All subjects who received at least one dose of study drug and who had at least one safety assessment post-Baseline.'}, {'type': 'SECONDARY', 'title': 'Describe Ibrexafungerp Plasma Concentrations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'classes': [{'title': 'Day 2 post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '479', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1790'}]}]}, {'title': 'Day 3-5 pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '644', 'groupId': 'OG000', 'lowerLimit': '9.21', 'upperLimit': '1980'}]}]}, {'title': 'Day 7-10 pre-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '571', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '1810'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose.', 'description': 'Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen:\n\nDay 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD', 'unitOfMeasure': 'nanograms per milliliter (ng/mL)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (Pk) Population - all enrolled participants who provided at least one Pk sample and with no deviations significant enough to affect interpretation of the Pk data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '233'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '109'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '233', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), orally administered QD for up to 180 days.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '16.23', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '128', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '105', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '219', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '180', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-11-21', 'size': 1281483, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-19T15:54', 'hasProtocol': True}, {'date': '2024-04-08', 'size': 627529, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-17T13:16', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open label, non-comparator, single arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2017-02-14', 'resultsFirstSubmitDate': '2024-09-19', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-28', 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by fungal disease. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological).\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Enrollment Category', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants who achieve a Global Response (defined as complete or partial response) as determined by the DRC by enrollment category, at disease specific timepoints. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological).\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Participants may have been enrolled for more than 1 enrollment reason.'}, {'measure': 'Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Disease Category.', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants who achieve Global Response (defined as complete or partial response) as determined by the DRC at disease specific timepoints by disease category. Global Response is measured by participant survival and overall effect of treatment on the disease. Complete response: Survival, all attributable signs/symptoms (including radiological) resolved and myoclogical eradication of disease; Partial response: Survival, improvement of attributable signs/symptoms (including radiological).\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases.'}, {'measure': 'Percentage of Participants With a Clinical Response (Based on Signs and Symptoms) by Disease Category', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Clinical Response as determined by the DRC at disease specific timepoints, by disease category. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) .\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.'}, {'measure': 'Percentage of Participants With a Clinical Response (Signs and Symptoms) by Disease Category and Pathogen', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Clinical Response as determined by the DRC by disease category and by pathogen isolated, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) .\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.'}, {'measure': 'Percentage of Participants With a Clinical Response (Signs and Symptoms) by Fungal Disease', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Clinical Response as determined by the DRC by fungal disease, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) .\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.'}, {'measure': 'Percentage of Participants With a Clinical Response (Signs and Symptoms) by Enrollment Category', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Clinical Response as determined by the DRC by enrollment category, at disease specific timepoints. Clinical Response: resolution or improvement in attributable symptoms and signs of disease and radiological abnormalities (if applicable) .\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Clinical response was evaluated based on disease signs (including radiological signs) and symptoms.'}, {'measure': 'Percentage of Participants With a Mycological Response by Disease Category', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Mycological Response as determined by the DRC by disease category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.'}, {'measure': 'Percentage of Participants With a Mycological Response by Disease Category and Pathogen', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Mycological Response as determined by the DRC by disease category and by pathogen, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.'}, {'measure': 'Percentage of Participants With a Mycological Response by Fungal Disease', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Mycological Response as determined by the DRC by fungal disease, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.'}, {'measure': 'Percentage of Participants With a Mycological Response by Enrollment Category', 'timeFrame': 'Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.', 'description': 'The percentage of participants with a Mycological Response as determined by the DRC by enrollment category, at disease specific timepoints. Mycological Response: evidence of eradication or clearance of cultures or reduction of fungal burden, as assessed by a quantitative and validated laboratory marker.\n\nDisease specific timepoints: End of Treatment (EoT) for invasive candidiasis, EoT or Day 84 for Chronic Mucocutaneous Candidiasis, Test of Cure (TOC) for Vulvovaginal Candidiasis, EoT or Day 90 for Chronic Pulmonary Aspergillosis, EoT or Day 90 Allergic Bronchopulmonary Aspergillosis and EoT for all other diseases. Mycological response was evaluated based on culture, microscopy and other biomarkers of fungal infection.'}, {'measure': 'Percentage of Participants With a Recurrence of Baseline Fungal Disease', 'timeFrame': '42 days for vulvovaginal candidiasis and 6 weeks after End of Treatment (up to 180 days after treatment start) for all other diseases.', 'description': 'The percentage of participants with a recurrence of their baseline fungal disease as assessed by the DRC at the 25-Day Follow Up (FU) for Vulvovaginal Candidiasis and at the 6-Week FU for all other diseases as assessed by the DRC. Recurrence is defined as having Global Response at end of treatment or test of cure, but re-emergence of the baseline fungal disease during the post treatment follow-up. Re-emergence is required to be with the same species and involving the same site identified at baseline.'}, {'measure': 'Percentage of Participants Surviving at Day 30 or Day 42', 'timeFrame': 'Day 30 post-Baseline for Invasive Candidiasis and Day 42 post-Baseline for all other fungal diseases.', 'description': 'Percentage of participants with invasive candidiasis surviving at Day 30 post-Baseline or percentage of participants with other fungal diseases surviving at Day 42 post-Baseline.'}, {'measure': 'Time to Death From Any Cause', 'timeFrame': 'Six weeks after End of Treatment (EOT). EOT for Vulvovaginal Candidiasis is Day 7, Chronic Mucocutaneous Candidiasis is up to Day 84, Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis is up to Day 90 and up to Day 180 for other.', 'description': 'Time to death from any cause in days per Fungal Disease'}, {'measure': 'Describe Ibrexafungerp Plasma Concentrations', 'timeFrame': 'Day 2 post-dose, Day 3-5 pre-dose, Dat 7-10 pre-dose.', 'description': 'Ibrexafungerp plasma concentrations measured at specified timepoints prior to and after administration of study drug for participants that received the following dose regimen:\n\nDay 1 and 2 loading dose - 750mg BID Day 3 onwards - 750mg QD'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Invasive Candidiasis', 'Mucocutaneous Candidiasis', 'Coccidioidomycosis', 'Histoplasmosis', 'Blastomycosis', 'Chronic Pulmonary Aspergillosis', 'Allergic Bronchopulmonary Aspergillosis', 'Invasive Pulmonary Aspergillosis', 'Recurrent Vulvovaginal Candidiasis', 'Other Emerging Fungi']}, 'referencesModule': {'references': [{'pmid': '31342066', 'type': 'BACKGROUND', 'citation': 'Davis MR, Donnelley MA, Thompson GR. Ibrexafungerp: A novel oral glucan synthase inhibitor. Med Mycol. 2020 Jul 1;58(5):579-592. doi: 10.1093/mmy/myz083.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.', 'detailedDescription': 'This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with ibrexafungerp for up to 180 days. Treatment beyond 180 days and combination therapy with other antifungal agents may be allowed under special circumstances to be agreed upon by the Investigator and the Sponsor.\n\nSubjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment.\n\nSubjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances.\n\nFollowing a screening visit, there will be up to 15 treatment visits, a follow-up visit and 2 follow-up contacts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment\n2. Be able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube\n3. Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.\n4. Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in the U.S. HIPAA Authorization form).\n5. Be able to understand and follow all study-related procedures including study drug administration.\n6. Agree to use a medically acceptable method of contraception while receiving protocol-assigned product.\n\nKey Exclusion Criteria:\n\n1. An invasive fungal disease with CNS involvement.\n2. Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters that cannot be removed and are likely the source of infection).\n3. Subject is hemodynamically unstable, requiring vasopressor medication for blood pressure support.\n4. A life expectancy \\< 30 days.\n5. Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \\>10 x the upper limit of normal (ULN), and/or total bilirubin \\> 5 x ULN.\n6. Subject is pregnant or lactating.\n7. Subject has used an investigational drug within 30 days prior to the baseline visit."}, 'identificationModule': {'nctId': 'NCT03059992', 'acronym': 'FURI', 'briefTitle': 'Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scynexis, Inc.'}, 'officialTitle': 'Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 (Ibrexafungerp) in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment (FURI)', 'orgStudyIdInfo': {'id': 'SCY-078-301'}, 'secondaryIdInfos': [{'id': '2017-000381-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibrexafungerp (SCY-078)', 'description': 'Ibrexafungerp (SCY-078), 750mg/day orally administered for up to 180 days with loading dose of 1500mg/day (for 2 days) for invasive fungal diseases.', 'interventionNames': ['Drug: Ibrexafungerp']}], 'interventions': [{'name': 'Ibrexafungerp', 'type': 'DRUG', 'otherNames': ['SCY-078'], 'description': 'Experimental Study Drug', 'armGroupLabels': ['Ibrexafungerp (SCY-078)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-0006', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', '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': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medical College', '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': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '15203', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburg Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390-8589', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medical University of Graz Department of Internal Medicine, Department of Pulmology, Section for Infectious Disease and Tropical Medicine', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '6020', 'city': 'Innsbruck', 'country': 'Austria', 'facility': 'Medical University Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}, {'zip': '50937', 'city': 'Cologne', 'country': 'Germany', 'facility': 'Universitätsklinikum Köln, Klinik I für Innere Medizin', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Universitätsklinikum Essen, Klinik für Infektiologie', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universitätsklinikum Frankfurt, Department of Internal Medicine II', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '04129', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'Klinikum St. Georg gGmbH Department for Infectious Disease, Tropical Medicine and Nephrology', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'LMU Klinikum der Universität München, Medizinische Klinik und Poliklinik III', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}, {'zip': '6525', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center, Department of Medicine Geert Grooteplein Zuid 8', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '74800', 'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}, {'zip': '0154', 'city': 'Lyttelton', 'state': 'Centurion', 'country': 'South Africa', 'facility': 'Johese Clinical Research', 'geoPoint': {'lat': -25.82988, 'lon': 28.2012}}, {'zip': '0181', 'city': 'Groenkloof', 'state': 'Pretoria', 'country': 'South Africa', 'facility': 'Into Research', 'geoPoint': {'lat': -31.78089, 'lon': 25.50906}}, {'zip': '1935', 'city': 'Three Rivers', 'state': 'Vereeniging', 'country': 'South Africa', 'facility': 'FCRN Clinical Trial Centre', 'geoPoint': {'lat': -26.65406, 'lon': 27.97621}}, {'zip': '0002', 'city': 'Pretoria', 'country': 'South Africa', 'facility': 'Emmed Research', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}, {'zip': '28007', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital General Universitario Gregorio Marañón', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitari i Politecnic La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': 'SW17 0RE', 'city': 'London', 'country': 'United Kingdom', 'facility': "St. George's University of London", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M13 9PL', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scynexis, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}