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 @ 4:59 PM
Ignite Modification Date: 2025-12-25 @ 2:40 PM
NCT ID: NCT04704050
Description: None
Frequency Threshold: 0
Time Frame: 13 Months
Study: NCT04704050
Study Brief: Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment Group Dronedarone 400 mg orally, twice per day (BID) dronedarone 400 mg Oral Tablet: Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV. Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks. 0 None 2 12 2 12 View
Control Group Placebo tablet orally, twice per day (BID) Placebo: Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks. 0 None 3 10 3 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
GERD SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Peripheral neuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased Troponin SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right lower extremity swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Left lower extremity swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Left upper extremity swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute gout flare-up SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute Tubular Necrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Fluid Overload SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hyperkalemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Worsening of Hyperlipidemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dyspnea on effort SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Elevated Creatinine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Prostate hyperplasia SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypoxemia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Right lung mass SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Intermittent Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upset Stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Excessive flatulence SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intermittent Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Right shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Right rotator cuff tear SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Spinal Stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Increased shoulder pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Elevated uric acid levels SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Rash on Chest SYSTEMATIC_ASSESSMENT General disorders None View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View