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 @ 12:36 AM
Ignite Modification Date: 2025-12-25 @ 10:45 PM
NCT ID: NCT03349567
Description: Other adverse events consisted of Clostridioides difficile infections
Frequency Threshold: 0
Time Frame: Outcomes were tracked for 30 days after each ED patient visit.
Study: NCT03349567
Study Brief: Improving Antimicrobial-Prescribing in Emergency Departments
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients Seen at Audit-and-feedback ED Sites During Intervention Period All patients seen in the EDs undergoing the audit-and-feedback intervention will be considered to have been exposed to the intervention. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at intervention sites. Because this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper. 141 None 1593 23164 11 23164 View
Patients Seen at Control ED Sites During the Intervention Period All patients seen in the EDs designated as control sites will be considered to have been part of the control group. For this adverse event reporting section, we are reporting ED patient-visits during the intervention period at control sites. Because this study was not randomized, a more accurate assessment of adverse events would require a difference-in-differences analysis across the baseline and intervention periods while controlling for baseline differences between intervention and control sites. Such an analysis is described in our statistical analysis plan and will be reported in our published paper. 176 None 1863 28835 27 28835 View
Patients Seen at Audit-and-feedback ED Sites During the Baseline Period For this adverse event reporting section, we are only reporting ED patient-visits at intervention sites during the baseline period. 146 None 1810 28016 193 28016 View
Patients Seen at Control EDs During the Baseline Period For this adverse event reporting section, we are reporting ED patient-visits at control sites during the baseline period. 197 None 2031 33077 321 33077 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization >24 hours after but within 30 days of ED visit SYSTEMATIC_ASSESSMENT General disorders None View
Mortality > 24 hours after ED visit and within 30 days of visit SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Clostridioides difficile infection SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View