Ignite Creation Date:
2025-12-25 @ 4:34 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT00413218
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2006-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'Egypt', 'Netherlands', 'Poland', 'South Korea', 'Turkey (Türkiye)', 'United Kingdom']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'id': 'D058387', 'term': 'Candidemia'}, {'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C508735', 'term': 'isavuconazole'}, {'id': 'D000077336', 'term': 'Caspofungin'}, {'id': 'D065819', 'term': 'Voriconazole'}], 'ancestors': [{'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '800-888-7704', 'title': 'Clinical Trial Disclosure', 'phoneExt': '5473', 'organization': 'Astellas Pharma Global Development, Inc.'}, 'certainAgreement': {'otherDetails': 'The results of this study may be published or presented at scientific meetings. If this is foreseen, the investigator agrees to submit all manuscripts or abstracts to the Sponsor at least 1 month prior to the submission of any such information to an editorial board or scientific review committee. This allows the Sponsor to protect proprietary information and to provide comments based on information from other studies that may not yet be available to the investigator.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Enrollment in the clinical study was suspended in January 2009 pending further characterization of newly identified impurities. After successful completion of the studies, regulatory notifications and transfer of sponsorship from Basilea to Astellas,'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 to FU2 (6 weeks after EOT (Day 56))', 'description': 'Treatment-emergent adverse events (TEAE) are AEs which started after the first use of study drug until FU2, and are based on the Safety Analysis Set (SAF) population. The SAF consisted of all participants who received at least one dose of study drug. SAF data were analyzed according to the first dose of study drug participants received even if it was different from what they were randomized to. One participant randomized to ISA received CAS on Day 1 and was included in CAS group for safety.', 'eventGroups': [{'id': 'EG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 162, 'seriousNumAtRisk': 220, 'deathsNumAffected': 55, 'seriousNumAffected': 112}, {'id': 'EG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 167, 'seriousNumAtRisk': 220, 'deathsNumAffected': 55, 'seriousNumAffected': 106}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 20, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 23, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 34, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 31, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 37, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 49, 'numAffected': 41}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 28, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 37, 'numAffected': 30}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 44, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 49, 'numAffected': 37}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 15, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 17, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 17, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 56, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 73, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Staphylococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Blood alkaline phosphatase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 49, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 50, 'numAffected': 44}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 22, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 31, 'numAffected': 29}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 16, 'numAffected': 14}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 15, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 14, 'numAffected': 13}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 18, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 19, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 13, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 29, 'numAffected': 27}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 20, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Anaemia haemolytic autoimmune', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Disseminated intravascular coagulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pancytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Coronary artery stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertensive heart disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pericardial effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sick sinus syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Torsade de pointes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Sickle cell anaemia with crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diabetes insipidus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Ascites', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 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'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Renal failure chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary alveolar haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Pulmonary necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Stevens-Johnson syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arterial thrombosis limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Arteriosclerosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Haemodynamic instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Jugular vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 12.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.3', 'groupId': 'OG000'}, {'value': '71.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.8', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '-1.8', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'The adjusted treatment difference (ISA-CAS) was calculated by a stratified Cochran-Mantel-Haenszel (CMH) method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The lower bound of the 95% CI for the adjusted treatment difference was compared to the protocol prespecified noninferiority margin (NIM) value of -15%. If the lower bound were greater than -15%, isavuconazole would be declared as noninferior to caspofungin.'}], 'paramType': 'NUMBER', 'timeFrame': 'End of Intravenous Treatment (EOIV) (Days 11-56)', 'description': 'A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all randomized participants who received at least one dose of study drug. The mITT population consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. Reporting arms included participants who switched to oral ISA and CAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.8', 'groupId': 'OG000'}, {'value': '57.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-12.2', 'ciUpperLimit': '6.8', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)', 'description': 'A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'title': 'EOT (Day 56)', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '72.1', 'groupId': 'OG001'}]}]}, {'title': 'FU2 (6 weeks after end of treatment)', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}, {'value': '48.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-10.9', 'ciLowerLimit': '-19.9', 'ciUpperLimit': '-1.9', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference %', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.4', 'ciLowerLimit': '-15.00', 'ciUpperLimit': '4.2', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'EOT (Day 56) and FU2 (6 weeks after end of treatment)', 'description': 'A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'title': 'Success- End of Intravenous Treatment (EOIV)', 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000'}, {'value': '84.1', 'groupId': 'OG001'}]}]}, {'title': 'Success- End of Treatment (EOT)', 'categories': [{'measurements': [{'value': '76.4', 'groupId': 'OG000'}, {'value': '84.6', 'groupId': 'OG001'}]}]}, {'title': 'Success- Follow-up Visit 1 (FU1)', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '67.7', 'groupId': 'OG001'}]}]}, {'title': 'Success- Follow-up Visit 2 (FU2)', 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000'}, {'value': '58.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.2', 'ciLowerLimit': '-15.4', 'ciUpperLimit': '-0.9', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.6', 'ciLowerLimit': '-15.8', 'ciUpperLimit': '-1.5', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.4', 'ciLowerLimit': '-9.1', 'ciUpperLimit': '8.3', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.8', 'ciLowerLimit': '-15.3', 'ciUpperLimit': '3.6', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)', 'description': 'A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'title': 'Success-EOIV', 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000'}, {'value': '85.6', 'groupId': 'OG001'}]}]}, {'title': 'Success-EOT', 'categories': [{'measurements': [{'value': '71.9', 'groupId': 'OG000'}, {'value': '87.6', 'groupId': 'OG001'}]}]}, {'title': 'Success-FU1', 'categories': [{'measurements': [{'value': '66.8', 'groupId': 'OG000'}, {'value': '65.7', 'groupId': 'OG001'}]}]}, {'title': 'Success-FU2', 'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000'}, {'value': '56.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-14.9', 'ciLowerLimit': '-22.7', 'ciUpperLimit': '-7.0', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at EOIV (Days 11-56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-15.9', 'ciLowerLimit': '-23.5', 'ciUpperLimit': '-8.4', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.7', 'ciLowerLimit': '-8.1', 'ciUpperLimit': '9.6', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at FU1 (2 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.2', 'ciLowerLimit': '-14.7', 'ciUpperLimit': '4.3', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at FU2 (6 weeks after end of treatment).The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)', 'description': 'A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '61.3', 'groupId': 'OG000'}, {'value': '72.1', 'groupId': 'OG001'}]}]}, {'title': 'EOT', 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000'}, {'value': '81.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.4', 'ciLowerLimit': '-20.4', 'ciUpperLimit': '-2.5', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.5', 'ciLowerLimit': '-16.5', 'ciUpperLimit': '-0.4', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7 and EOT (Day 56)', 'description': 'Success was defined as mycological response (eradication or presumed eradication).', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic participants could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole once daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'title': 'Day 7', 'categories': [{'measurements': [{'value': '54.3', 'groupId': 'OG000'}, {'value': '64.7', 'groupId': 'OG001'}]}]}, {'title': 'EOT', 'categories': [{'measurements': [{'value': '70.9', 'groupId': 'OG000'}, {'value': '78.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-11.1', 'ciLowerLimit': '-20.3', 'ciUpperLimit': '-1.9', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at Day 7. The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-8.1', 'ciLowerLimit': '-16.3', 'ciUpperLimit': '0.1', 'estimateComment': 'The 95% CI for the adjusted treatment difference was calculated based on a normal approximation.', 'groupDescription': 'Statistical analysis of adjusted treatment difference (ISA-CAS) at EOT (Day 56). The adjusted treatment difference (ISA-CAS) was calculated by a stratified CMH method with the strata of geographical region and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 7 and EOT (Day 56)', 'description': 'Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC. The isavuconazole and caspofungin group included participants who switched to oral isavuconazol and voriconazole'}, {'type': 'SECONDARY', 'title': 'All-Cause Mortality (ACM) at Day 14 and Day 56', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '201', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'title': 'Day 14 All-cause Mortality', 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000'}, {'value': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Day 56 All-cause Mortality', 'categories': [{'measurements': [{'value': '30.7', 'groupId': 'OG000'}, {'value': '29.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-3.8', 'ciUpperLimit': '8.9', 'groupDescription': 'Statistical analysis of all-cause mortality on Day 14. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Treatment Difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '-7.1', 'ciUpperLimit': '10.0', 'groupDescription': 'Statistical analysis of all-cause mortality on Day 56. Adjusted treatment difference (Isavuconazole-Caspofungin) is calculated by a stratified CMH method with the strata of geographical regions, and baseline neutropenic status.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Day 14 and Day 56', 'description': 'All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC.'}, {'type': 'SECONDARY', 'title': 'Time to First Confirmed Negative Culture', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'OG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '6.0'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 up to FU1 (2 weeks after EOT (Day 56))', 'description': "The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis", 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The mITT was the primary efficacy population and it consisted of ITT participants who had documented invasive candidiasis or candidemia at baseline based on the assessment of the independent blinded DRC.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'FG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Four hundred and fifty participants were randomized but 10 participants did not receive treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '227'}]}, {'type': 'Intent to Treat Population (ITT)', 'comment': 'The ITT consisted of all randomized participants who received at least one dose of study drug.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '221'}, {'groupId': 'FG001', 'numSubjects': '219'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '120'}, {'groupId': 'FG001', 'numSubjects': '131'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '96'}]}], 'dropWithdraws': [{'type': "Randomized but didn't receive study drug", 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '57'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'Admin', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Consenting male and female participants ≥ 18 with candidemia or an invasive Candida infection who had a positive blood or tissue culture obtained within 96 hours prior to randomization and meeting the inclusion/exclusion criteria were enrolled in the study.', 'preAssignmentDetails': 'Participants were stratified at randomization by geographical region and baseline neutropenic status.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '440', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.'}, {'id': 'BG001', 'title': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. Participants with body weight \\> 80 kg received 70 mg CAS daily. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'spread': '17.54', 'groupId': 'BG000'}, {'value': '57.9', 'spread': '16.88', 'groupId': 'BG001'}, {'value': '58.0', 'spread': '17.20', 'groupId': 'BG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '269', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '120', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '187', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '382', 'groupId': 'BG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Neutropenic Status: Presence or Absence of Neutropenia', 'classes': [{'categories': [{'title': 'Presence', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Absence', 'measurements': [{'value': '196', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by baseline neutropenic status (presence vs absence of neutropenia) defined as absolute neutrophil count (ANC) \\< 0.5 x 10\\^9/L \\[\\< 500/mm\\^3\\] for ≥ 10 days.', 'unitOfMeasure': 'Participants'}, {'title': 'Geographical Region', 'classes': [{'categories': [{'title': 'North America', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Western Europe', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Other Regions', 'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '259', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified at randomization by geographical region. The region Western Europe includes countries in Western Europe (Belgium, France, Germany, Italy, Spain and Switzerland), Australia and New Zealand. Other regions include countries Argentina, Brazil, Chile, China, Hungary, India, Israel, Lebanon, Malaysia, Mexico, Philippines, South Africa, Russia, Singapore and Thailand.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'dispFirstSubmitDate': '2015-08-17', 'completionDateStruct': {'date': '2015-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-15', 'studyFirstSubmitDate': '2006-12-18', 'dispFirstSubmitQcDate': '2015-08-17', 'resultsFirstSubmitDate': '2017-07-05', 'studyFirstSubmitQcDate': '2006-12-18', 'dispFirstPostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-05', 'studyFirstPostDateStruct': {'date': '2006-12-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Overall Response of Success at the End of Intravenous Therapy (EOIV) as Determined by the Data Review Committee (DRC) Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use', 'timeFrame': 'End of Intravenous Treatment (EOIV) (Days 11-56)', 'description': 'A Data Review Committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication) without the use of alternative systemic antifungal therapy (AFT) within 48 hours after the last dose of IV study medication.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Overall Response of Success at Follow Up Visit 1 (FU1-2 Weeks After End of Treatment (EOT)) as Determined by the DRC Based on the Assessments of Clinical, Mycological Responses and Antifungal Therapy (AFT)', 'timeFrame': 'End of Treatment (EOT) (Day 56) and FU1 (2 weeks after end of treatment)', 'description': 'A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic AFT within 48 hours after the last dose of IV study medication.'}, {'measure': 'Percentage of Participants With Overall Response of Success at EOT and Follow Up Visit 2 (FU2) as Determined by the DRC Based on the Assessments of Clinical and Mycological Responses as Well as Alternative Systemic AFT Use at EOT and FU2', 'timeFrame': 'EOT (Day 56) and FU2 (6 weeks after end of treatment)', 'description': 'A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial) and mycological response (eradication or presumed eradication), without the use of alternative systemic antifungal therapy AFT within 48 hours after the last dose of IV study medication (for EOT analysis) or for continued treatment of the primary infection, or for recurrent or emergent infection by FU2, with no recurrent or emergent infection by FU2 (for FU2 analysis).'}, {'measure': 'Percentage of Participants With Clinical Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)', 'timeFrame': 'EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)', 'description': 'A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as clinical response (complete or partial).'}, {'measure': 'Percentage of Participants With Mycological Response of Success at EOIV, EOT, FU1 and FU2 as Determined by the Data Review Committee (DRC)', 'timeFrame': 'EOIV (Days 11-56), EOT (Day 56), FU1 (2 weeks after end of treatment) and FU2 (6 weeks after end of treatment)', 'description': 'A data review committee (DRC) was established from independent experts in the field of fungal infections to determine diagnosis and outcomes independently of the investigators and sponsor. Success was defined as mycological response (Eradication or Presumed Eradication).'}, {'measure': 'Percentage of Participants With Mycological Response of Success at Day 7 and EOT as Determined by The Investigator', 'timeFrame': 'Day 7 and EOT (Day 56)', 'description': 'Success was defined as mycological response (eradication or presumed eradication).'}, {'measure': 'Percentage of Participants With Clinical Response of Success at Day 7 and EOT as Determined by The Investigator', 'timeFrame': 'Day 7 and EOT (Day 56)', 'description': 'Investigators defined clinical response as success if participants exhibited complete or partial clinical response after evaluation of clinical signs and symptoms.'}, {'measure': 'All-Cause Mortality (ACM) at Day 14 and Day 56', 'timeFrame': 'Day 14 and Day 56', 'description': 'All-cause mortality is represented as the percentage of participants who died on or before the analysis day. Participants who were lost to follow-up (i.e., unknown survival status) before the analysis day were counted as death. All-cause mortality was examined on Day 14 and Day 56.'}, {'measure': 'Time to First Confirmed Negative Culture', 'timeFrame': 'Day 1 up to FU1 (2 weeks after EOT (Day 56))', 'description': "The first confirmed negative blood culture was defined as the first negative blood culture on or after first dose followed by a second negative blood culture at least 24 hours apart without any positive blood cultures in between. A participant without a confirmed negative blood culture was censored on the participant's last visit day. This endpoint was analyzed for mITT participants with candidemia only using the Kaplan-Meier method. Only participants with at least one positive blood culture on or prior to first dose and the culture not resolved prior to first dose were included in this analysis"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Invasive Candida infections', 'BAL8557', 'ASP9766', 'Isavuconazole', 'Candidemia', 'Candidemia and other invasive candida infections', 'Phase III study'], 'conditions': ['Candidiasis, Invasive', 'Candidemia', 'Mycoses']}, 'referencesModule': {'references': [{'pmid': '30289478', 'type': 'DERIVED', 'citation': 'Kullberg BJ, Viscoli C, Pappas PG, Vazquez J, Ostrosky-Zeichner L, Rotstein C, Sobel JD, Herbrecht R, Rahav G, Jaruratanasirikul S, Chetchotisakd P, Van Wijngaerden E, De Waele J, Lademacher C, Engelhardt M, Kovanda L, Croos-Dabrera R, Fredericks C, Thompson GR. Isavuconazole Versus Caspofungin in the Treatment of Candidemia and Other Invasive Candida Infections: The ACTIVE Trial. Clin Infect Dis. 2019 May 30;68(12):1981-1989. doi: 10.1093/cid/ciy827.'}, {'pmid': '25902926', 'type': 'DERIVED', 'citation': 'McCormack PL. Isavuconazonium: first global approval. Drugs. 2015 May;75(7):817-22. doi: 10.1007/s40265-015-0398-6.'}], 'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=295', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to compare the safety and efficacy of isavuconazole versus caspofungin followed by voriconazole in the treatment of candidemia and other invasive Candida infections.', 'detailedDescription': 'Candida infections, representing approximately 80% of all major systemic fungal infections, are the fourth most common cause of nosocomial bloodstream infections, with a mortality rate of 40%. Isavuconazole is not yet approved for the treatment of fungal infections. This study investigates the efficacy and safety of intravenous and oral isavuconazole. Patients are randomized to isavuconazole and the reference regimen. Patients with a positive blood- or deep tissue culture of candida fungi can be included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with candidemia or with an invasive Candida infection\n* Presence of fever, hypothermia or other appropriate local sign of infection\n* Female patients must be non-lactating and at no risk of pregnancy\n\nExclusion Criteria:\n\n* Patients with a sole diagnosis of mucocutaneous candidiasis, i.e. oropharyngeal, esophageal or genital candidiasis; or candidal lower urinary tract infection or Candida isolated solely from respiratory tract specimens\n* Patients with candidemia who failed a previous antifungal therapy for the same infection\n* Patients previously enrolled in a phase III study with isavuconazole\n* Patients with a body weight \\<40kg'}, 'identificationModule': {'nctId': 'NCT00413218', 'briefTitle': 'Isavuconazole (BAL8557) in the Treatment of Candidemia and Other Invasive Candida Infections', 'nctIdAliases': ['NCT00444366'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase III, Double-blind, Randomized Study to Evaluate the Safety and Efficacy of BAL8557 Versus a Caspofungin Followed by Voriconazole Regimen in the Treatment of Candidemia and Other Invasive Candida Infections', 'orgStudyIdInfo': {'id': '9766-CL-0105'}, 'secondaryIdInfos': [{'id': 'WSA-CS-008', 'type': 'OTHER', 'domain': 'Basilea Pharmaceutica Ltd'}, {'id': '2006-003951-18', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isavuconazole (ISA)', 'description': 'Participants received 3 intravenous (IV) loading doses of 200 mg of isavuconazole on days 1 and 2, followed by an IV maintenance dose of 200 mg once daily from day 3 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV to oral therapy. Oral therapy consisted of 200 mg isavuconazole twice daily.', 'interventionNames': ['Drug: Isavuconazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Caspofungin (CAS)/Voriconazole', 'description': 'Participants received 1 intravenous (IV) loading dose of 70 mg CAS on day 1, followed by an IV maintenance dose of 50 mg CAS from day 2 to day 56. On day 11 at the discretion of the investigator, non-neutropenic patients could switch from IV CAS to oral voriconazole comprising of a loading dose of 400 mg twice daily (BID) on the first day of oral therapy followed by standard dosing of 200 mg BID thereafter.', 'interventionNames': ['Drug: Caspofungin', 'Drug: Voriconazole']}], 'interventions': [{'name': 'Isavuconazole', 'type': 'DRUG', 'otherNames': ['ASP9766', 'BAL8557'], 'description': 'Administered by intravenous infusion.', 'armGroupLabels': ['Isavuconazole (ISA)']}, {'name': 'Caspofungin', 'type': 'DRUG', 'otherNames': ['Cancidas'], 'description': 'Administered by intravenous infusion.', 'armGroupLabels': ['Caspofungin (CAS)/Voriconazole']}, {'name': 'Voriconazole', 'type': 'DRUG', 'otherNames': ['VFend'], 'description': 'Administered by intravenous infusion.', 'armGroupLabels': ['Caspofungin (CAS)/Voriconazole']}]}, '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': '92211', 'city': 'Palm Desert', 'state': 'California', 'country': 'United States', 'facility': 'Somero Research Corporation', 'geoPoint': {'lat': 33.72255, 'lon': -116.37697}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Health System', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Idaho Falls Infectious Diseases PLLC', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}, {'zip': '60153', 'city': 'Maywood', 'state': 'Illinois', 'country': 'United States', 'facility': 'Loyola University Hospital', 'geoPoint': {'lat': 41.8792, 'lon': -87.84312}}, {'zip': '62701', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Springfield Clinic LLP', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46280', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Infectious Disease of Indiana', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMASS Memorial Medical Center', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical Group', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '07753', 'city': 'Neptune City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Jersey Shore University Medical Center', 'geoPoint': {'lat': 40.20011, 'lon': -74.02792}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45801', 'city': 'Lima', 'state': 'Ohio', 'country': 'United States', 'facility': 'Regional Infection Diseases Infusion Center Inc.', 'geoPoint': {'lat': 40.74255, 'lon': -84.10523}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Health Sciences', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': 'C1280AEB', 'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'Hospital Britanico de Buenos Aires'}, {'zip': 'C1405DCS', 'city': 'Capital Federal', 'country': 'Argentina', 'facility': 'Hospital General de Agudos Dr. Carlos G. 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