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 @ 1:32 PM
Ignite Modification Date:
2025-12-25 @ 12:33 PM
NCT ID:
NCT03347695
Description:
in-hospital mortality rate, stroke or transient ischemic attack(TIA), heart failure, permanent pacemaker implantation, renal failure, pneumonia, sepsis, respiratory failure, and multiple organ dysfunction syndrome, which are defined by protocol within 12 months after surgery.
Frequency Threshold:
0.5
Time Frame:
Within 12 Months After Surgery
Study:
NCT03347695
Study Brief:
A New Operation for the Treatment for Long-standing Atrial Fibrillation
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| A New Operation (Selected Pilot Study) | Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation (Selected): Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. | 0 | None | 1 | 20 | 0 | 20 | View |
| A New Operation | Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. Left atrial geometric volume reduction, pulmonary veins island isolation and left appendage ligation: Two circular incisions were performed in the left atrial wall between the pulmonary veins and the mitral annulus. with those two incisions, circumferential resection of a strip for the left atrial was obtained. The middle of pulmonary vein island was longitudinal plicated and the left appendage was ligated. Finally,the plicated pulmonary island was directly anastomosed to the lest side free wall, inferior wall, roof, the posterior walls of both superior and inferior vein cavae, and intra-atrial septum. | 4 | None | 24 | 120 | 2 | 120 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| 30-day (in-hospital) mortality | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| stroke or transient ischemic attack(TIA) | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| heart failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| permanent pacemaker implantation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| multiple organ dysfunction syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Reoperation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| deep sternal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| infective endocarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| superficial wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |