Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 5:38 PM
Ignite Modification Date: 2025-12-25 @ 3:08 PM
NCT ID: NCT04160468
Description: All adverse events (AEs) and serious adverse events (SAEs) were collected from the time of consent through the Day 60 visit. Treatment emergent AEs, defined as an AE that occurred during or after study drug administration through the Day 60 visit (Day 60 ±7 days), are presented in the overall population in the safety analysis set.
Frequency Threshold: 5
Time Frame: Through the Day 60 visit
Study: NCT04160468
Study Brief: Direct Lysis of Staph Aureus Resistant Pathogen Trial of Exebacase
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exebacase + SoCA Participants received a single IV infusion of exebacase in addition to standard-of-care antibiotics (SoCA) selected by the investigator. 27 None 71 165 72 165 View
SoCA Alone Participants received a single IV infusion of placebo in addition to standard-of-care antibiotics (SoCA) selected by the investigator. 14 None 34 85 41 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Staphylococcal bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Endocarditis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Clostridium difficile infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Abscess limb SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Bacteremia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Bone abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Cavernous sinus thrombosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Intervertebral discitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Klebsiella infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Neutropenic sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Pharyngeal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Staphylococcal infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Systemic candida SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Vascular device infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Candida sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Acute pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Dyspnea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Cardiac tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Acute left ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA Version 23.0 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
End stage renal disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Renal impairment SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Renal tubular necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Gastrointestinal hemorrage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Intestinal angioedema SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Intra-abdominal hemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Mesenteric artery thrombosis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Peritoneal hematoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 23.0 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 23.0 View
Hypertensive emergency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 23.0 View
Acute disseminated encephalomyelitis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Cerebrospinal fluid leakage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Metabolic encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Subarachnoid hemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Ischemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 23.0 View
Death NOS (not otherwise specified) SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.0 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.0 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.0 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.0 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 23.0 View
Ischemic hepatitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 23.0 View
Cirrhosis alcoholic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 23.0 View
Hepatic cirrhosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 23.0 View
Hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 23.0 View
Chronic hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA Version 23.0 View
Wound dehiscense SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 23.0 View
Heart injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 23.0 View
Tracheal obstruction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 23.0 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 23.0 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 23.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 23.0 View
Heparin-induced thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 23.0 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA Version 23.0 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 23.0 View
Drug abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA Version 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 23.0 View
Patient dissatisfaction with treatment SYSTEMATIC_ASSESSMENT Social circumstances MedDRA Version 23.0 View
Social stay hospitalization SYSTEMATIC_ASSESSMENT Social circumstances MedDRA Version 23.0 View
Mixed deafness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 23.0 View
Malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 23.0 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 23.0 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 23.0 View
Fluid overload SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 23.0 View
Plasmacytoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA Version 23.0 View
Device dislocation SYSTEMATIC_ASSESSMENT Product Issues MedDRA Version 23.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 23.0 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 23.0 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Pulmonary edema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 23.0 View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 23.0 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 23.0 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA Version 23.0 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA Version 23.0 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 23.0 View
Hypomagnesemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA Version 23.0 View