Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 12:21 PM
Ignite Modification Date: 2025-12-25 @ 12:03 PM
NCT ID: NCT04880161
Description: Patients were followed for the occurrence of Adverse Events for 60 days following the first dose of study medication. One participant from the Active population was randomized, but did not receive treatment and thus was not included from the safety population.
Frequency Threshold: 0
Time Frame: Baseline to Day 60
Study: NCT04880161
Study Brief: A Study to Evaluate Ampion in Patients With Prolonged Respiratory Symptoms Due to COVID-19 (Long COVID)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Ampion Ampion: Inhaled nebulized Ampion (8 mL) administered four times daily, every four to six hours, for five days. 0 None 0 15 8 15 View
Control Placebo Placebo: Inhaled nebulized saline (8 mL) administered four times daily, every four to six hours, for five days. 0 None 0 16 9 16 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra (24.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra (24.0) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra (24.0) View
Paraesthesia Oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDra (24.0) View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDra (24.0) View
Chills SYSTEMATIC_ASSESSMENT General disorders MedDra (24.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDra (24.0) View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDra (24.0) View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDra (24.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDra (24.0) View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDra (24.0) View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra (24.0) View
Pain in Jaw SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDra (24.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra (24.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra (24.0) View
Paraesthesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra (24.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDra (24.0) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra (24.0) View
Oropharyngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra (24.0) View
Productive Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra (24.0) View
Wheezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDra (24.0) View
Skin Ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDra (24.0) View
Alcohol Abuse SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDra (24.0) View