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 @ 4:28 PM
Ignite Modification Date: 2025-12-25 @ 2:20 PM
NCT ID: NCT03226366
Description: Intervention effects on hospital mortality and emergency department length of stay were evaluated as study outcomes. Other adverse events were not systematically collected given this was a retrospective study employing review of the electronic clinical record to evaluate a previously-implemented quality improvement initiative reordering of routine emergency department care for patients with sepsis.
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT03226366
Study Brief: Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Pre-implementation (Intervention Site) Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016 19 None 0 911 0 911 View
Post-implementation (Intervention Site) Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016 Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate 7 None 0 495 0 495 View
Pre-implementation (Control Site) Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016 23 None 0 1183 0 1183 View
Post-implementation (Control Site) Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and November 15, 2016 11 None 0 641 0 641 View
Serious Events(If Any):
Other Events(If Any):