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 @ 2:01 AM
Ignite Modification Date: 2025-12-26 @ 12:25 AM
NCT ID: NCT00832260
Description: Serious Adverse Events were collected
Frequency Threshold: 5
Time Frame: 12 months
Study: NCT00832260
Study Brief: IES-ACap: Influence of Atrial Pulse Width in the Behaviour of ACap™ Confirm Algorithm.
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zephyr Pacemaker Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical None None 18 70 0 70 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Implant of a Percutaneous transluminal coronary angioplasty (PTCA) NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hemorrhoids surgery NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Bipolar disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Seizure crisis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Seizure crisis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pyramidal Syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Stent NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Thoracic pain NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Transtympanic drain NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Decrease in immunological system NON_SYSTEMATIC_ASSESSMENT Immune system disorders None View
Tracheotomy NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hernioplasty NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cerebral Hemorrhage NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cholangitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Dyspnea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Prostatectomy NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Pneumothorax NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial Flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Macroscopic Hematuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Possible strange body in a wound. NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Palpitations NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):