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 @ 2:03 AM
Ignite Modification Date: 2025-12-26 @ 12:27 AM
NCT ID: NCT03498560
Description: This study is an observational study, not an interventional study. Thus, all adverse events patients encounter during this time period would not be related to the research study. Adverse events and other events were determined by regular chart review.
Frequency Threshold: 0
Time Frame: Adverse event data was collected form the time the patient was enrolled to the completion of the follow-up assessment at 30 days.
Study: NCT03498560
Study Brief: Examining the Association Between Pre-existing Sleep Disturbance and Postoperative Delirium
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MGH Surgery Patients PSG data will be collected, and delirium assessments conducted, on patients undergoing surgery at MGH. PSG: PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance. 1 None 0 38 0 38 View
Serious Events(If Any):
Other Events(If Any):