Viewing Study NCT00250432

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Ignite Creation Date: 2025-12-24 @ 9:44 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
Study NCT ID: NCT00250432
Status: COMPLETED
Last Update Posted: 2017-03-24
First Post: 2005-11-04
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Brazil', 'Bulgaria', 'Croatia', 'Czechia', 'Ecuador', 'France', 'Germany', 'India', 'Italy', 'Latvia', 'Mexico', 'Norway', 'Panama', 'Portugal', 'Romania', 'Taiwan', 'United Arab Emirates', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077336', 'term': 'Caspofungin'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Caspofungin 70/50 mg', 'description': 'Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)', 'otherNumAffected': 69, 'seriousNumAffected': 46}, {'id': 'EG001', 'title': 'Caspofungin 150 mg', 'description': 'Caspofungin 150 mg IV daily', 'otherNumAffected': 70, 'seriousNumAffected': 44}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ventricular Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Adrenal Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Gastrointestinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Haematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Generalised Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypothermia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Injection Site Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Injection Site Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Injection Site Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Jaundice', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Empyema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Staphylococcal Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Activated Partial Thromboplastin Time Prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Aspartate Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Albumin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Alkaline Phosphatase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Bilirubin Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Calcium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Calcium Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Chloride Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Creatinine Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Glucose Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Magnesium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Phosphorus Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Potassium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Potassium Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Sodium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Sodium Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Urea Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Blood Uric Acid Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Carbon Dioxide Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'White Blood Cell Count Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypokalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lung Infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 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'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Cerebral Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Myasthenia Gravis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Partial Seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Oliguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Acute Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Acute Respiratory Distress Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Lung Infiltration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Respiratory Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Haemodynamic Instability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Peripheral Vascular Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Shock Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Venous Thrombosis Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Who Develop Significant Drug-related Adverse Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caspofungin 70/50 mg', 'description': 'Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)'}, {'id': 'OG001', 'title': 'Caspofungin 150 mg', 'description': 'Caspofungin 150 mg IV daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-4.1', 'ciUpperLimit': '6.8', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.6', 'estimateComment': 'The confidence interval computation was based on the method by Miettinen and Nurminen.', 'groupDescription': 'A significant drug-related adverse event was defined as either a drug-related serious adverse event or a drug-related adverse event leading to discontinuation of caspofungin therapy. Comparison between the 2 caspofungin groups was based on upper bound of the 95% confidence interval for the difference.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Safety with caspofungin 150 mg daily will be non-inferior to that of caspofungin 70/50 mg. Non-inferiority was defined as upper limit of the 2-sided, 95% confidence interval for the difference (150-mg group - 70/50-mg group) must be less than 0.15 (15 percentage points).'}], 'paramType': 'NUMBER', 'timeFrame': '90 Days', 'description': 'Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients as treated population'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a Favorable Overall Response.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caspofungin 70/50 mg', 'description': 'Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)'}, {'id': 'OG001', 'title': 'Caspofungin 150 mg', 'description': 'Caspofungin 150 mg IV daily'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate Difference', 'ciPctValue': '95', 'paramValue': '6.3', 'ciLowerLimit': '-5.9', 'ciUpperLimit': '18.4', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '12.1', 'estimateComment': 'The 95% confidence interval on the difference will be based on the method of Miettinen and Nurminen.', 'groupDescription': 'There was no formal hypothesis testing for efficacy in this study. The main efficacy analysis was the number (percentage) of patients with a favorable overall response at the end of caspofungin study therapy, together with the within treatment 95% exact binomial confidence intervals, and the estimated treatment difference, and its 95% confidence interval.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '90 Days', 'description': 'Number of patients with a favorable overall response, defined as a clinical response of "cure" or "apparent cure" along with a microbiological response of "eradication" or "presumptive eradication" at the End of Caspofungin Therapy.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): Included those patients who received at least 1 full dose of caspofungin study therapy and had a documented diagnosis of invasive candidiasis from a sterile, invasive body site, as defined in the protocol.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caspofungin 70/50 mg', 'description': 'Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)'}, {'id': 'FG001', 'title': 'Caspofungin 150 mg', 'description': 'Caspofungin 150 mg IV daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '53'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '45'}, {'groupId': 'FG001', 'numSubjects': '47'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Patient Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Pt died out of posttherapy report period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Pt was considered untreatable', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "This was a Phase III study. The first patient was enrolled (FPE) on 13-Jan-2006. The last patient's last visit (LPLV) was on 13-Mar-2008. A total of 38 inpatient centers were involved in the recruitment worldwide (14 in the United States, 13 in the European Union, 7 in Central or South America, and 4 in Asia)"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caspofungin 70/50 mg', 'description': 'Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)'}, {'id': 'BG001', 'title': 'Caspofungin 150 mg', 'description': 'Caspofungin 150 mg IV daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.0', 'groupId': 'BG000', 'lowerLimit': '16', 'upperLimit': '90'}, {'value': '57.8', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '87'}, {'value': '56.9', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '90'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Site Of Invasive Candida Infection', 'classes': [{'title': 'Abscess(involving an intra-abdominal site)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Abscess (involving a non-abdominal site)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Acute disseminated candidiasis or multiple sites', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Blood (candidemia)', 'categories': [{'measurements': [{'value': '91', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}, {'title': 'Chronic disseminated candidiasis (hepatosplenic)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Fungemia (non Candida)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Kidney (Pyelonephritis)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Lung (Pneumonia)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Peritoneal fluid (Peritonitis)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'Pleural fluid (Empyema)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This table lists the site of invasive candidiasis. Patients are included in only 1 category. Patients with more than 1 site of infection are counted under "Acute disseminated candidiasis or multiple sites".', 'unitOfMeasure': 'Participants'}, {'title': 'APACHE II Score (at Study Entry)', 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '38'}, {'value': '17.0', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '39'}, {'value': '16.8', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '39'}]}]}], 'paramType': 'MEAN', 'description': 'APACHE (Acute Physiology and Chronic Health Evaluation) is a system of classifying severity of illnesses in intensive care patients. The possible range of values is 0 (minimum severity) to 71 (maximum severity).', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-21', 'studyFirstSubmitDate': '2005-11-04', 'resultsFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2005-11-04', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-03-23', 'studyFirstPostDateStruct': {'date': '2005-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-03-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Who Develop Significant Drug-related Adverse Events.', 'timeFrame': '90 Days', 'description': 'Number of patients with at least 1 significant drug-related adverse event (serious drug-related or drug-related adverse events leading to caspofungin discontinuation) while on caspofungin study therapy or during the immediate 14-day post-caspofungin therapy period.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With a Favorable Overall Response.', 'timeFrame': '90 Days', 'description': 'Number of patients with a favorable overall response, defined as a clinical response of "cure" or "apparent cure" along with a microbiological response of "eradication" or "presumptive eradication" at the End of Caspofungin Therapy.'}]}, 'conditionsModule': {'conditions': ['Invasive Candidiasis']}, 'referencesModule': {'references': [{'pmid': '19419331', 'type': 'BACKGROUND', 'citation': 'Betts RF, Nucci M, Talwar D, Gareca M, Queiroz-Telles F, Bedimo RJ, Herbrecht R, Ruiz-Palacios G, Young JA, Baddley JW, Strohmaier KM, Tucker KA, Taylor AF, Kartsonis NA; Caspofungin High-Dose Study Group. A Multicenter, double-blind trial of a high-dose caspofungin treatment regimen versus a standard caspofungin treatment regimen for adult patients with invasive candidiasis. Clin Infect Dis. 2009 Jun 15;48(12):1676-84. doi: 10.1086/598933.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of the safety and effectiveness of standard drug dosing versus a daily dose 3 times higher than the standard dose in patients with invasive candidiasis (bloodstream and/or systemic yeast infections)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical and Laboratory evidence of blood stream \\&/or systemic candida infections\n\nExclusion Criteria:\n\n* Possible candida contamination\n* Candida colonization (non invasive infection), urine, cardiac, bone or brain and prosthetic device infections\n* Acute or moderately severe liver disease\n* Abnormal liver function tests\n* Abnormal blood clotting for patients on blood thinners'}, 'identificationModule': {'nctId': 'NCT00250432', 'briefTitle': 'A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of an Antifungal Drug in the Treatment of Fungal Infections in Adults (0991-801)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of 2 Dosing Regimens of Caspofungin in the Treatment of Invasive Candidiasis in Adults', 'orgStudyIdInfo': {'id': '0991-801'}, 'secondaryIdInfos': [{'id': '2005_085'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '50 mg intravenous (IV) infusion (diluted with 9% saline) administered daily (following a 70-mg IV loading dose on Day 1), over the course of \\~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection.', 'interventionNames': ['Drug: caspofungin acetate']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '150 mg intravenous (IV) infusion (diluted with 9% saline) administered daily, over the course of \\~2 hrs. all patients should be treated with antifungal therapy for at least 14 days following both the improvement in clinical and radiographic signs of disease and the eradication of Candida from culture samples obtained from the invasive site of infection.', 'interventionNames': ['Drug: caspofungin acetate']}], 'interventions': [{'name': 'caspofungin acetate', 'type': 'DRUG', 'description': 'Caspofungin acetate 50 mg IV infusion (diluted with 9% saline) (following a 70-mg IV loading dose on Day 1); Caspofungin acetate 150 mg IV infusion (diluted with 9% saline) administered daily, over the course of \\~2 hrs. Duration of Treatment - 14-90 days.', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\\_Updated%20July\\_9\\_2014.pdf\n\nhttp://engagezone.msd.com/ds\\_documentation.php'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}