Adverse Events Module

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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 @ 4:11 PM
Ignite Modification Date: 2025-12-25 @ 2:11 PM
NCT ID: NCT01334866
Description: Adverse events were classified as serious by the PI following ISO 14155 standards.
Frequency Threshold: 5
Time Frame: Adverse events reported from treatment through 6-month follow-up.
Study: NCT01334866
Study Brief: Graft Patency Outcomes in Patients Undergoing Coronary Artery Bypass Grafting Via Minimally Invasive Coronary Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Procedure Cohort 89 Subjects received study treatment None None 14 89 46 89 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia and blood loss SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Bowel Obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Low Cardiac Index SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Surgical Blood Loss SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Subcutaneous Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Atelectasis and Pleural Effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View