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 @ 7:58 PM
Ignite Modification Date: 2025-12-25 @ 5:32 PM
NCT ID: NCT03192904
Description: The adverse events occurred were described.
Frequency Threshold: 0
Time Frame: Three months after surgery.
Study: NCT03192904
Study Brief: Comparison of Energy Instruments and Stapling Device to Dissect Intersegmental Plane in Segmentectomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Energy Instruments Group All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use energy instruments dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Energy Instruments: Energy Instruments, including electrocautery, harmonic scalpel and LigaSure. 0 None 1 32 0 32 View
Stapling Device Group All enrolled patients will accept robot-assisted or uniportal segmentectomy. After cutting off the relevant segmental arteries and veins, we clamp the segmental bronchus, and then the diseased lung will be ventilated to identify the border of segment according to the collapse region. We use stapling device to dissect intersegmental plane along the determined border. If fast-frozen pathology confirms lung cancer, we will do lymphadenectomy. At last, a drainage tube will be placed. Stapling Device: Stapling Device, including linear stapler and curved stapler. 0 None 1 33 0 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Septic shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):