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 @ 2:44 PM
Ignite Modification Date: 2025-12-25 @ 1:13 PM
NCT ID: NCT04778059
Description: AEs were collected at all study visits from the time of dosing.
Frequency Threshold: 0
Time Frame: Up to 70 days
Study: NCT04778059
Study Brief: Safety and Efficacy of USB002 for Respiratory Distress Due to COVID-19
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
USB002 90 ug/kg/Day Subjects received standard of care plus a continuous IV infusion of 90 ug/kg/day USB002 for up to 96 hours. 2 None 2 3 2 3 View
USB002 300 ug/kg/Day Subjects received standard of care plus a continuous IV infusion of 300 ug/kg/day USB002 for up to 96 hours. 2 None 2 3 3 3 View
USB002 600 ug/kg/Day Subjects received standard of care plus a continuous IV infusion of 600 ug/kg/day USB002 for up to 96 hours. 1 None 1 3 2 3 View
USB002 900 ug/kg/Day Subjects received standard of care plus a continuous IV infusion of 900 ug/kg/day USB002 for up to 96 hours. 1 None 1 2 2 2 View
Placebo Subjects received standard of care plus a continuous IV infusion of USB002 placebo for up to 96 hours. 1 None 1 10 8 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Withdrawal of life support SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 24 View
Multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
COVID-19 pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Eosinophilia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Leukopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 24 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Right ventricular dysfunction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 24 View
Hyperthyroidism SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 24 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Swelling face SYSTEMATIC_ASSESSMENT General disorders MedDRA 24 View
Acute hepatic failure SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 24 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia fungal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia klebsiella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Pneumonia staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24 View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 24 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Aspartate aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Fibrin D dimer increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
International normalised ratio increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypoalbuminaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypocalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Hypophosphataemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 24 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Tremor SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 24 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 24 View
Acute respiratory distress syndrome SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Hiccups SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 24 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 24 View
Haematoma SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View
Shock SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 24 View