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 @ 5:08 AM
Ignite Modification Date: 2025-12-26 @ 4:12 AM
NCT ID: NCT06057727
Description: Per our DSMB-approved DSMP, severe adverse events will not include death as no reasonable evidence exists to suggest death would result from outreach or communication to encourage standard clinical care for flu vaccination. Therefore, All-Cause Mortality was not assessed. Adverse events are assessed for the Main Study Period arms only - Control (except Messaging, see footnote) and Intervention - as the patients in the High Risk arms are already accounted for in the Intervention arm total.
Frequency Threshold: 0
Time Frame: Each patient was monitored for adverse events for 3 months. Adverse events were collected mid-way through the trial at 3 months for all participants enrolled through the end of December 2023 and again at the end of the trial follow up period, 3 months after enrollment ended (May 2024), for all enrolled participants.
Study: NCT06057727
Study Brief: Behavioral Economics to Improve Flu Vaccination Using EHR Nudges
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Patients in clinics randomized to the control arm will receive standard of care. 0 None 0 27513 5 27513 View
Intervention Patients in clinics randomized to the intervention arm will receive the toolkit of clinician and patient facing nudges. Patient nudges will be pre-visit text message reminders (standard messaging content). Clinician nudges will be monthly peer comparison feedback and default pended orders. Includes all intervention arm patients, including high risk. 0 None 1 52526 817 52526 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Flu Vaccine Reaction SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Messaging Opt-out SYSTEMATIC_ASSESSMENT Social circumstances None View
Duplicate Vaccination SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View