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 @ 5:39 PM
Ignite Modification Date: 2025-12-25 @ 3:09 PM
NCT ID: NCT05780268
Description: None
Frequency Threshold: 0
Time Frame: 90 days
Study: NCT05780268
Study Brief: LY3819253 (LY-CoV555) for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
LY3819253 Plus SOC * LY3819253 7000 mg solution (10 vials of 20 mL solution containing 700 mg each); administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion LY3819253: LY3819253 is a neutralizing immunoglobulin G (IgG)-1 monoclonal antibody (mAb) to the receptor binding domain (RBD) of the S protein of SARS-CoV-2 Remdesivir: Antiviral agent 13 None 9 163 41 163 View
Placebo Plus SOC * Placebo administered by IV infusion * Remdesivir is provided to all study participants as SOC unless contraindicated for an individual patient; administered by IV infusion Placebo: Commercially available 0.9% sodium chloride solution Remdesivir: Antiviral agent 11 None 12 151 27 151 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Arrhythmia supraventricular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary artery stenosis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal ischaemia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Systemic inflammatory response syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cholecystitis infective NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paraspinal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hypokalaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponataemis NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Transitional cell carcinoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Chronic obstructive pulonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Angioedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypertensive urgency NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Coagulopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Febrile neutropenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Thrombocytopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Arrhythmia supraventricular NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sinus bradycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pancreatitits NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chills NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hypothermia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Odema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Clostridium difficile colitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia staphylococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudomonas infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Paraspinal abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Candida infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Infusion related reaction NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Haemoglobin decreased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Hepatic enzyme increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Liver function test increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
10016803 NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyperglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglyceamia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatraemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Muscular weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizzyness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Encephalopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Panic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Mental status changes NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Acute kidney injury NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hypoxia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumoththorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory distress NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Angioedema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View