Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-04-23 @ 11:20 PM
Study NCT ID:
NCT02469857
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2015-06-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019115', 'term': 'Fasciitis, Necrotizing'}, {'id': 'D018934', 'term': 'Fournier Gangrene'}], 'ancestors': [{'id': 'D005208', 'term': 'Fasciitis'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597133', 'term': 'AB103'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wayned@atoxbio.com', 'phone': '1-919-219-6377', 'title': 'Wayne M Dankner, MD, Chief Medical Officer', 'organization': 'Atox Bio, Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.', 'description': 'Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod (AB103) 0.5 mg/kg, single IV infusion over approximately 10 minutes', 'otherNumAtRisk': 143, 'deathsNumAtRisk': 143, 'otherNumAffected': 24, 'seriousNumAtRisk': 143, 'deathsNumAffected': 24, 'seriousNumAffected': 44}, {'id': 'EG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 25, 'seriousNumAtRisk': 147, 'deathsNumAffected': 29, 'seriousNumAffected': 40}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}], 'seriousEvents': [{'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Coronary artery perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pulmonary valve incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pulseless electrical activity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Abdominal compartment syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Intestinal infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Lower gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Rectal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Small intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Upper gastrointestinal hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Multiple organ dysfunction syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Organ failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hepatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hepatic function abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Liver disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Funguria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Necrotizing fasciitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Necrotizing soft tissue infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Wound infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hypoglycemic coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Device malfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Acute lung injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Acute respiratory distress syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Bronchopleural fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Skin discoloration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Skin necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Leg amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Extremity necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Malignant hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}, {'term': 'Peripheral ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 147, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'title': 'mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'US-mITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.135', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis utilized the mITT analysis population.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.025', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'This analysis utilized the US-mITT analysis population.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure (i.e., a "responder"): (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. This analysis compared responders in the reltecimod group versus responders in the placebo group.\n\nModified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary analysis population (modified intent-to-treat \\[mITT\\]) included all randomized patients who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification.\n\nA secondary analysis of the primary outcome measure utilized the United States-modified intent-to-treat (US-mITT) analysis population which consisted only of mITT patients enrolled in the United States.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With One or More Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AB103 0.5 mg/kg', 'description': 'AB103 0.5 mg/kg, IV infusion, single dose'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, IV infusion, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of Patients With One or More Adverse Events (AEs). Serious Adverse Events (SAEs) are included in this outcome measure since SAEs are a subset of AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With One or More Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AB103 0.5 mg/kg', 'description': 'AB103 0.5 mg/kg, IV infusion, single dose'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, IV infusion, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of Patients with One or More Serious Adverse Events (SAEs) During the Study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With One or More Secondary Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AB103 0.5 mg/kg', 'description': 'AB103 0.5 mg/kg, IV infusion, single dose'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, IV infusion, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'Number of Patients with One or More Secondary Infections During the Study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.069', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France.'}, {'type': 'SECONDARY', 'title': 'Intensive Care Unit (ICU)-Free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '0.401', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France.'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '21.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '0.195', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France.'}, {'type': 'SECONDARY', 'title': 'Vasopressor-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '28'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'analyses': [{'pValue': '0.596', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '28 days', 'description': 'Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France.'}, {'type': 'SECONDARY', 'title': 'Hospital Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '103'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '135'}]}]}], 'analyses': [{'pValue': '0.512', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': '90 days or until end of follow up', 'description': 'Hospital days refers to the number of days a patient spent time in the hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a More Favorable or Less Favorable Hospital Discharge Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'title': 'More Favorable Discharge Location', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}, {'title': 'Less Favorable Discharge Location', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths From Day 0 Through Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.554', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.85', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.46', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'The number of deaths occurring from Study Day 0 through Study Day 90', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths After Day 14 Through Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.148', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.54', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.26', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '76 days (after Day 14 through Day 90)', 'description': 'Number of deaths after Study Day 14 through Study Day 90', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population alive on Day 14 (119 reltecimod patients and 124 placebo patients) were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths From Day 0 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.736', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.46', 'ciUpperLimit': '1.73', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 0 and subsequently died through Study Day 90.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with a Screening mSOFA score of at least 5 were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths After Day 14 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.093', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.34', 'ciLowerLimit': '0.09', 'ciUpperLimit': '1.25', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '76 days (after Day 14 through Day 90)', 'description': 'Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 14 and subsequently died through Study Day 90.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with a Screening mSOFA score of at least 5 who were alive on Day 14 (64 reltecimod patients and 69 placebo patients) were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths From Day 0 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.352', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.71', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.46', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'Number and percentage of patients with baseline cardiovascular failure (shock) who died through Study Day 90.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 75 reltecimod patients and 56 placebo patients) were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Deaths After Day 14 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.21', 'ciLowerLimit': '0.04', 'ciUpperLimit': '0.99', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '76 days (after Day 14 through Day 90)', 'description': 'Number and percentage of patients with baseline cardiovascular failure (shock) who were alive on Study Day 14 and subsequently died through Study Day 90.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 63 reltecimod patients and 48 placebo patients) were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With a Screening Modified Sequential Organ Failure Assessment (mSOFA) Score of at Least 5 Who Achieved NICCE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.024', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14.\n\nModified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with a Screening mSOFA score of at least 5 (77 reltecimod patients and 79 placebo patients) were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With a Screening mSOFA Score of at Least 5 Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with a Screening mSOFA score of at least 5 (77 reltecimod patients and 79 placebo patients) were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '28 days', 'description': 'NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 75 reltecimod patients and 56 placebo patients) were included in this analysis.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '14 days', 'description': 'Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 75 reltecimod patients and 56 placebo patients) were included in this analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'As Treated (Safety) Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}, {'groupId': 'FG001', 'numSubjects': '147'}]}, {'type': 'COMPLETED', 'comment': 'As Treated (Safety) Analysis Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '29'}]}, {'type': 'Discontinuation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '290', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Reltecimod (AB103) 0.5 mg/kg', 'description': 'Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'NaCl 0.9%, single IV infusion over approximately 10 minutes'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.4', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '56.3', 'spread': '15.0', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '15.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '88', 'groupId': 'BG001'}, {'value': '173', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '110', 'groupId': 'BG001'}, {'value': '216', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Instead of collecting data in the categories "More than one race" and "Unknown or Not Reported," data were collected in the categories "Other" and "Missing." Counts of participants in these latter 2 categories were summed and included in the category of "Unknown or Not Reported" in this study record.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '273', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'This measure represents the two countries from which patients were enrolled into this study and received study drug (i.e., United States and France).', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '33.7', 'spread': '8.3', 'groupId': 'BG001'}, {'value': '32.5', 'spread': '8.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Necrotizing Soft Tissue Infection (NSTI) Diagnosis', 'classes': [{'categories': [{'title': 'Necrotizing Fasciitis', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}, {'title': "Fournier's Gangrene", 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Gas Gangrene/Myonecrosis', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Other NSTI', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'title': 'Diabetes', 'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}, {'title': 'Cardiovascular Disease', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': 'Smoker', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}, {'title': 'Alcohol Abuse', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Modified Sequential Organ Failure Assessment (mSOFA) Score', 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '2.5', 'groupId': 'BG000'}, {'value': '5.4', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '5.5', 'spread': '2.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Acute Physiology And Chronic Health Evaluation II (APACHE II) Score', 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '6.8', 'groupId': 'BG000'}, {'value': '16.4', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '16.4', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Acute Physiology and Chronic Health Evaluation (APACHE) Score is a severity of illness classification system. It is determined within 24 hours of admission of a patient to an intensive care unit (ICU): an integer score from 0 to 71 is computed based on several measurements (physiologic variables, age, chronic health status). Higher scores correspond to more severe disease and a greater risk of death.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sepsis Presentation', 'classes': [{'title': 'Cardiovascular Organ Failure', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}, {'title': 'Respiratory Organ Failure', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Sepsis presentation is based on mSOFA cardiovascular and respiratory sub-score components equal to 3 or 4.', 'unitOfMeasure': 'Participants'}, {'title': 'Acute Kidney Injury (AKI) Presentation', 'classes': [{'title': 'Any AKI at Screening', 'categories': [{'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '190', 'groupId': 'BG002'}]}]}, {'title': 'Stage 2 or 3 AKI at Screening', 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '143', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Stages of acute kidney injury (AKI) refer to the Kidney Disease: Improving Global Outcomes (KDIGO) stages of AKI. There are 3 KDIGO stages of AKI that are based on serum creatinine or urine output. Stage 1 represents the least severity of AKI, while Stage 3 represents the greatest severity of AKI.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'This analysis population (As Treated/Safety Analysis Set) included all randomized patients who were exposed to study drug (reltecimod or placebo), with patients analyzed according to the treatment actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-23', 'size': 1960657, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-08-27T15:33', 'hasProtocol': True}, {'date': '2019-09-24', 'size': 1018743, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-08-27T15:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'dispFirstSubmitDate': '2021-01-25', 'completionDateStruct': {'date': '2019-10-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-02', 'studyFirstSubmitDate': '2015-06-06', 'dispFirstSubmitQcDate': '2021-01-25', 'resultsFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2015-06-11', 'dispFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-10-02', 'studyFirstPostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Deaths From Day 0 Through Day 90', 'timeFrame': '90 days', 'description': 'The number of deaths occurring from Study Day 0 through Study Day 90'}, {'measure': 'Number of Deaths After Day 14 Through Day 90', 'timeFrame': '76 days (after Day 14 through Day 90)', 'description': 'Number of deaths after Study Day 14 through Study Day 90'}, {'measure': 'Number of Deaths From Day 0 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5', 'timeFrame': '90 days', 'description': 'Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 0 and subsequently died through Study Day 90.'}, {'measure': 'Number of Deaths After Day 14 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5', 'timeFrame': '76 days (after Day 14 through Day 90)', 'description': 'Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 14 and subsequently died through Study Day 90.'}, {'measure': 'Number of Deaths From Day 0 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock)', 'timeFrame': '90 days', 'description': 'Number and percentage of patients with baseline cardiovascular failure (shock) who died through Study Day 90.'}, {'measure': 'Number of Deaths After Day 14 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock)', 'timeFrame': '76 days (after Day 14 through Day 90)', 'description': 'Number and percentage of patients with baseline cardiovascular failure (shock) who were alive on Study Day 14 and subsequently died through Study Day 90.'}, {'measure': 'Number of Patients With a Screening Modified Sequential Organ Failure Assessment (mSOFA) Score of at Least 5 Who Achieved NICCE', 'timeFrame': '28 days', 'description': 'NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14.\n\nModified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.'}, {'measure': 'Number of Patients With a Screening mSOFA Score of at Least 5 Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1', 'timeFrame': '14 days', 'description': 'Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.'}, {'measure': 'Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE', 'timeFrame': '28 days', 'description': 'NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14.'}, {'measure': 'Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1', 'timeFrame': '14 days', 'description': 'Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.'}], 'primaryOutcomes': [{'measure': 'Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE)', 'timeFrame': '28 days', 'description': 'NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure (i.e., a "responder"): (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. This analysis compared responders in the reltecimod group versus responders in the placebo group.\n\nModified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With One or More Adverse Events (AEs)', 'timeFrame': '28 days', 'description': 'Number of Patients With One or More Adverse Events (AEs). Serious Adverse Events (SAEs) are included in this outcome measure since SAEs are a subset of AEs.'}, {'measure': 'Number of Patients With One or More Serious Adverse Events (SAEs)', 'timeFrame': '28 days', 'description': 'Number of Patients with One or More Serious Adverse Events (SAEs) During the Study'}, {'measure': 'Number of Patients With One or More Secondary Infections', 'timeFrame': '28 days', 'description': 'Number of Patients with One or More Secondary Infections During the Study'}, {'measure': 'Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1', 'timeFrame': '14 days', 'description': 'Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.'}, {'measure': 'Intensive Care Unit (ICU)-Free Days', 'timeFrame': '28 days', 'description': 'ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.'}, {'measure': 'Ventilator-free Days', 'timeFrame': '28 days', 'description': 'Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.'}, {'measure': 'Vasopressor-free Days', 'timeFrame': '28 days', 'description': 'Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.'}, {'measure': 'Hospital Days', 'timeFrame': '90 days or until end of follow up', 'description': 'Hospital days refers to the number of days a patient spent time in the hospital.'}, {'measure': 'Number of Patients With a More Favorable or Less Favorable Hospital Discharge Location', 'timeFrame': '90 days', 'description': 'Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AB103', 'Necrotizing fasciitis'], 'conditions': ['Necrotizing Soft Tissue Infections', 'Necrotizing Fasciitis', "Fournier's Gangrene"]}, 'referencesModule': {'references': [{'pmid': '32657946', 'type': 'RESULT', 'citation': 'Bulger EM, May AK, Robinson BRH, Evans DC, Henry S, Green JM, Toschlog E, Sperry JL, Fagenholz P, Martin ND, Dankner WM, Maislin G, Wilfret D, Bernard AC; ACCUTE Study Investigators. A Novel Immune Modulator for Patients With Necrotizing Soft Tissue Infections (NSTI): Results of a Multicenter, Phase 3 Randomized Controlled Trial of Reltecimod (AB 103). Ann Surg. 2020 Sep 1;272(3):469-478. doi: 10.1097/SLA.0000000000004102.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether AB103 is safe and effective in the treatment of patients with necrotizing soft tissue infections (NSTI) receiving standard of care therapy.', 'detailedDescription': "The primary hypothesis of this study is that in addition to standard of care treatment (which includes surgical intervention, antimicrobial therapy and critical care support for organ dysfunction or failure), AB103 will demonstrate a clinically significant treatment benefit over placebo.\n\nThis hypothesis will be addressed by measuring the effect of AB103 on a composite of clinical parameters associated with the disease course of patients with NSTI, using a responder analysis. A responding patient must meet all 5 parameters of the composite clinical success end point, while a non-responding patient can fail by not meeting any one of the parameters. These analyses are designed to demonstrate that in addition to being safe, one dose of 0.5 mg/kg of AB103 will:\n\nImprove systemic signs of the infection by improving organ function of patients compared to placebo as measured by:\n\n* Survival at Day 28\n* Modified SOFA (mSOFA) score on Day 14 and change from baseline to Day 14 ≥ 3. A Day 14 mSOFA score of ≤1 and a change from baseline (pre-treatment) to Day 14 ≥3 will be required for a patient to achieve the primary composite clinical success endpoint (NICCE)\n\nImprove the local signs of the infection, as measured by:\n\n* Reduced number of debridements, counted to Day 14. No more than 3 debridements to Day 14 will be required for a patient to achieve composite clinical success\n* No amputation after the first debridement (amputation on the first debridement is not considered a failure). A patient will be required to have had no amputations done after the first surgical procedure in order to achieve composite clinical success.\n\n 290 patients will be recruited into the study and randomized to receive either 0.5 mg/kg AB103 or placebo in a 1:1 ratio. Randomization will be stratified within center by the diagnosis of Fournier's Gangrene and mSOFA score category (3-4 vs \\>4) at screening. The study will be conducted with interim analyses for futility at 100 patients and safety monitored by an independent Data Monitoring Board at regular planned intervals."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Surgical confirmation of NSTI by attending surgeon;\n2. mSOFA score ≥3 (in any one or combination of the 5 major components of SOFA score with one organ component having a score of at least 2: cardiovascular, respiratory, renal, coagulation, CNS), measured as close as possible to the first debridement;\n3. IV drug administration within 6 hours from the clinical diagnosis and the decision at the study site, to have an urgent surgical exploration and debridement (drug should not be administered until surgical confirmation is established);\n4. If a woman is of childbearing potential, she must consistently use an acceptable method of contraception from baseline through Day 28;\n5. If a male patient's sexual partner is of childbearing potential, the male patient must acknowledge that they will consistently use an acceptable method of contraception (defined above) from baseline through Day 28.\n6. Signed and dated informed consent (ICF) as defined by the Institutional Review Board (IRB) and, if applicable, California Bill of Rights. If patient is unable to comprehend or sign the ICF, patient's legally acceptable representative may sign the ICF\n\nExclusion Criteria:\n\n1. BMI\\>51;\n2. Patient who has been operated at least once for the current NSTI infection and had a curative deep tissue debridement;\n3. Patients with overt peripheral vascular disease in the involved area ;\n4. Diabetic patients with peripheral vascular disease who present with below the ankle infection;\n5. Removed deep vein thrombosis (DVT) in area of NSTI as an exclusion criteria\n6. Patient with burn wounds;\n7. Current condition of: (a) Inability to maintain a mean arterial pressure \\> 50 mmHg and/or systolic blood pressure \\> 70 mmHg for at least 1 hour prior to screening despite the presence of vasopressors and IV fluids or (b) a patient with respiratory failure such that an SaO2 of 80% cannot be achieved or (c) a patient with refractory coagulopathy (INR \\>5) or thrombocytopenia (platelet count \\<20,000) that does not partially correct with administration of appropriate factors or blood products;\n8. Chronic neurological impairment that leads to a neuro mSOFA component ≥2;\n9. Recent cerebrovascular accident in the last 3 months;\n10. Patients with cardiac arrest requiring cardiopulmonary resuscitation within the past 30 days;\n11. Patient is not expected to survive throughout 28 days of study due to underlying medical condition, such as poorly controlled neoplasm;\n12. Patient or patient's family are not committed to aggressive management of the patient's condition;\n13. Any concurrent medical condition, which in the opinion of the Investigator, may compromise the safety of the patient or the objectives of the study or the patient will not benefit from treatment such as:\n\n * Congestive heart failure (CHF){ New York Heart Association (NYHA) class III-IV}\n * Severe chronic pulmonary obstructive disease (COPD)\n * Liver dysfunction {Childs-Pugh class C}\n * Immunosuppression (see Appendix F, Section 15.6 for list of excluded immunosuppressive medications)\n * Neutropenia \\< 1,000 cells/mm3not due to the underlying infection\n * Idiopathic Thrombocytopenia Purpura\n * Receiving or about to receive chemotherapy or biologic anti-cancer treatment although hormonal manipulation therapies for breast and prostate malignancies are permitted\n * Hematological and lymphatic malignancies in the last 5 years;\n14. Known HIV infection with CD4 (cluster of differentiation 4) count \\< 200 cells/mm3 or \\< 14% of all lymphocytes;\n15. Patients with known chronic kidney disease (documented pre-illness creatinine value(s) ≥2.0) or patients receiving renal replacement therapy for chronic kidney disease;\n16. Patients that are treated with continuous hemofiltration (e.g. Continuous Veno-Venous Hemofiltration) for acute kidney dysfunction, not due to NSTI, starting prior to study drug administration;\n17. Pregnant or lactating women;\n18. Previous enrollment in a clinical trial involving investigational drug or a medical device within 30 days;\n19. Previous enrollment in this protocol, ATB-202 or the Phase 2 trial of AB103, ATB-201."}, 'identificationModule': {'nctId': 'NCT02469857', 'acronym': 'ACCUTE', 'briefTitle': 'Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Atox Bio Ltd'}, 'officialTitle': 'Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Study of AB103 as Compared to Placebo in Patients With Necrotizing Soft Tissue Infections. ACCUTE (AB103 Clinical Composite Endpoint Study in Necrotizing Soft Tissue Infections)', 'orgStudyIdInfo': {'id': 'ATB-202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AB103 0.5 mg/kg', 'description': 'AB103 0.5 mg/kg, IV, single dose', 'interventionNames': ['Drug: AB103 0.5 mg/kg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'NaCl 0.9%', 'description': 'NaCl 0.9%, IV, single dose', 'interventionNames': ['Other: NaCl 0.9%']}], 'interventions': [{'name': 'AB103 0.5 mg/kg', 'type': 'DRUG', 'otherNames': ['reltecimod'], 'armGroupLabels': ['AB103 0.5 mg/kg']}, {'name': 'NaCl 0.9%', 'type': 'OTHER', 'otherNames': ['Normal saline'], 'armGroupLabels': ['NaCl 0.9%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85008', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Maricopa Medical Center', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '24857', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner University Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '90502', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Los Angeles Biomedical Research Institute at Harbor UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'UCH-Memorial Health System', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'UF Health Shands Hospital', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Ryder Trauma Center/Jackson Memorial Hospital', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University at Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Augusta University Health', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospital and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Our Lady of the Lake Regional Medical Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Baton Rouge General Hospital', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'LSU Health Science Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '04102', 'city': 'Portland', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Medical Center', 'geoPoint': {'lat': 43.65737, 'lon': -70.2589}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland R Adams Cowley Shock Trauma Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University-Detroit Receiving Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48235', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University-Sinai Grace Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Fairview Southdale Hospital', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Hennepin County Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center-Fairview', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '65211', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63103', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper University Hospital', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '98638', 'city': 'Trenton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Capital Health System, Inc.', 'geoPoint': {'lat': 40.21705, 'lon': -74.74294}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '14215', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Erie County Medical Center-Affliate of SUNYat Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10305', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Staten Island University Hospital-Northwell Health', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '28208', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Medical Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina University', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati Medical Center (UCMC)', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44109', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'The MetroHealth System', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45409', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State University & Premier Health Clinical Trials Research Alliance', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44501', 'city': 'Youngstown', 'state': 'Ohio', 'country': 'United States', 'facility': 'St Elizabeth Youngstown Hospital', 'geoPoint': {'lat': 41.09978, 'lon': -80.64952}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Emanuel Hospital', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health and Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Luke's University Health Network", 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Pennsylvania State University and The Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Trauma Center at PENN', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '79905', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Tech University Health Sciences Center at El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'John Peter Smith Health Network', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine-Ben Taub Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76502', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott and White Medical Center', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin-Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Hộpital Estaing-CHU de Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Créteil', 'country': 'France', 'facility': 'Hộpital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'Hôpital Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'city': 'Lille', 'country': 'France', 'facility': 'Robert Salengro Hopital-CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Limoges', 'country': 'France', 'facility': 'CHU de Limoges', 'geoPoint': {'lat': 45.83362, 'lon': 1.24759}}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hôpital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Nancy', 'country': 'France', 'facility': 'CHRU Nancy, Hôpital Central', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}, {'city': 'Nîmes', 'country': 'France', 'facility': 'CHU de Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'city': 'Orléans', 'country': 'France', 'facility': 'Hôpital de la Source, CHR Orleans', 'geoPoint': {'lat': 47.90248, 'lon': 1.90407}}, {'city': 'Tours', 'country': 'France', 'facility': 'CHRU Bretonneau', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Wayne M Dankner, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Atox Bio Ltd'}, {'name': 'Eileen M Bulger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harborview Injury Prevention and Research Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atox Bio Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biomedical Advanced Research and Development Authority', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}