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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT01757704
Description: Participants medical charts were studied to find reported signs of postoperative neurological dysfunction that included clinical signs of stroke or transient neurological deficit. Transient neurological dysfunction was defined as severe confusion, agitation or hallucinations.
Frequency Threshold: 5
Time Frame: Postoperative hospital stay, an average of 7 Days.
Study: NCT01757704
Study Brief: Factors Responsible for the Effectiveness of the Lund De-airing Technique
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intact Pleurae & Staged Filling of Heart In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Intact pleurae \& staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar None None 1 10 1 10 View
Open Pleurae & Conventional Filling of Heart In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes. Open pleurae \& conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag None None 0 10 0 10 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders SNOMED CT View