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 @ 4:11 AM
Ignite Modification Date: 2025-12-26 @ 3:10 AM
NCT ID: NCT02726620
Description: We utilized our perioperative information management system to determine the number of adverse events that occurred associated with the patients' intraoperative course. We used our hospital registration system to determine all cause mortality for this patient population.
Frequency Threshold: 5
Time Frame: We analyzed adverse events in this patient population during their intraoperative course (adverse events sourced from our adverse event reporting system; from entry into OR to exit from OR), and during their hospitalization (source for mortality data; from hospital admission to hospital discharge).
Study: NCT02726620
Study Brief: Decision Support for Intraoperative Low Blood Pressure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Group The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm). 534 None 1811 17463 0 17463 View
Hypotension Decision Support The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails. Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider. All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia. 158 None 541 4972 0 4972 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute Kidney Injury Stage I or greater SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Mortality SYSTEMATIC_ASSESSMENT Investigations None View
Other Events(If Any):