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: 2025-12-25 @ 1:21 AM
Ignite Modification Date: 2025-12-25 @ 11:30 PM
NCT ID: NCT02628093
Description: Since this is a standard of care procedures no adverse events were recorded. However all intraoperative and postoperative complications were documented as described in the protocol. All the complications that were collected are not qualifying as serous adverse event per protocol.
Frequency Threshold: 5
Time Frame: 30 days
Study: NCT02628093
Study Brief: A ProspectiveTrial Comparing THUNDERBEAT to the Ligasure Energy Device During Laparoscopic Colon 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
THUNDERBEAT THUNDERBEAT energy device ( Olympus) will be used for dissection of tissue and ligation of vessels THUNDERBEAT: Tissue dissection and vessels ligation 0 None 0 31 3 31 View
LIGASURE LIGASURE energy device will be used for dissection of tissue and ligation of vessels LIGASURE: Tissue dissection and vessels ligation 0 None 0 29 9 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Postoperative Rectal Bleeding SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anastomotic leak SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Wound hematoma incision SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View