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 @ 11:47 PM
Ignite Modification Date: 2025-12-25 @ 9:41 PM
NCT ID: NCT05009251
Description: This is a minimal risk study, and has received expedited IRB review in keeping with 45 CFR ยง 46.110. EHR and claims data will report inputs (i.e., the subject's assigned arm) and outcomes (i.e., flu vaccination, flu diagnosis, flu-like symptoms). We therefore did not monitor the data for AE/SAEs. However, on 10/7/2021, we completed a data pull with an updated death record check, and patients who died during the study as of that data pull are indicated under All-Cause Mortality.
Frequency Threshold: 0
Time Frame: Roughly 1 month (9/9/21 - 10/7/21)
Study: NCT05009251
Study Brief: Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
No-Contact Control Subjects in the no-contact control arm will receive no additional pro-vaccination intervention beyond the health system's normal efforts. Although some patients are currently targeted for flu vaccination encouragement due to a conventional non-ML assessment that they are at high risk for complications, these patients are not told that they are at high risk or that they have been targeted. 25 None 0 0 0 0 View
Reminder Control Subjects in the reminder control arm will receive messages reminding them to get the flu shot without being advised of their risk status. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message 22 None 0 0 0 0 View
High Risk Only Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications, without specifying how or why the health system believes this to be the case. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message 24 None 0 0 0 0 View
High Risk With Explanation Based on Medical Records Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via review of their medical records and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message 19 None 0 0 0 0 View
High Risk With Explanation Based on Algorithm Subjects in this treatment arm will receive messages telling them they have been identified to be at high risk for flu complications via analysis of their medical records by a computer algorithm and will be provided a human-understandable short list of the top factors from their medical record that explain their risk. Reminder: Mailed letter, short message service (SMS) text, and/or patient portal message Risk reduction: Mailed letter, SMS, and/or patient portal message Medical records-based recommendation: Mailed letter, SMS, and/or patient portal message Algorithm-based recommendation: Mailed letter, SMS, and/or patient portal message 17 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):