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: 2025-12-25 @ 4:04 AM
Ignite Modification Date: 2025-12-26 @ 3:00 AM
NCT ID: NCT05350202
Description: Safety set: All registered patients who gave informed consent and who received empagliflozin at least once. As per protocol, patients not receiving empagliflozin were not observed past Visit 1, and adverse events were not collected.
Frequency Threshold: 5
Time Frame: From start of empagliflozin to its last administration plus 7 days. Up to 25 weeks.
Study: NCT05350202
Study Brief: Emp-Activity: Empagliflozin Functional Capacity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Empagliflozin-treated Patients Patients with heart failure (HF), with or without diabetes, who received their first prescription of empagliflozin were treated according to the approved product information, with a recommended daily dose of 10 milligrams (mg). 46 None 74 3309 0 3309 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Acute kidney injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardio-respiratory arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Hospitalisation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 27.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 27.1 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiopulmonary failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Cardiovascular disorder SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Coronary artery bypass SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 27.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Diabetic ketoacidosis SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 27.1 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Escherichia pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Genital haemorrhage SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.1 View
Implantable defibrillator insertion SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 27.1 View
Myopathy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 27.1 View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Necrotising oesophagitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 27.1 View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 27.1 View
Peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 27.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 27.1 View
Polyneuropathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 27.1 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 27.1 View
Pulmonary fibrosis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 27.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 27.1 View
Tachyarrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 27.1 View
Vulvovaginal pruritus SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 27.1 View
Other Events(If Any):