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 @ 9:20 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT03624504
Description: Subjects will be assessed for AEs at all scheduled and unscheduled visits. All procedure related, system related, accessory related, underlying condition or disease related, and serious AEs will be collected on the electronic Case Report Forms (eCRFs).
Frequency Threshold: 5
Time Frame: From implant attempt to last subject follow-up, ranging from 0 to 14 months
Study: NCT03624504
Study Brief: China Micra Transcatheter Pacing Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Micra Implant Group Subjects with implant attempt with the Micra Transcatheter Pacing System (TPS) Micra Transcatheter Pacing System (TPS): Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements 0 None 12 82 8 82 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Angina unstable NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Cardiac failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Pericardial effusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 22.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 22.0 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 22.0 View
Cholangitis acute NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 22.0 View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View
Gouty arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 22.0 View
Hepatic angiosarcoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 22.0 View
Lacunar infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Vertebrobasilar insufficiency NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 22.0 View
Pleurisy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 22.0 View
Arteriovenous fistula NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 22.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 22.0 View