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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT04706403
Description: All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
Frequency Threshold: 0
Time Frame: None
Study: NCT04706403
Study Brief: Views on COVID-19 and Vaccination
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Message 1 Participants were randomized to receive version #1 of 5 different versions of a message from a physician regarding the COVID-19 vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 1, this statement was followed by a participatory-style recommendation ("What do you think?") 0 None 0 0 0 0 View
Message 4 Participants were be randomized to receive version #4 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 4, this statement was followed by an acknowledgment of concerns and reassurance that the physician personally reviewed the safety data and an explicit recommendation ("I recommend that you get it"). 0 None 0 0 0 0 View
Message 5 Participants were randomized to receive version #5 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 5, this statement was followed by an emphasis on protecting others an explicit recommendation ("I recommend that you get it"). 0 None 0 0 0 0 View
Message 2 Participants were randomized to receive version #2 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 2, this statement was followed by a comparison of the COVID-19 vaccine to the flu shot and an explicit recommendation ("I recommend that you get it"). 0 None 0 0 0 0 View
Message 3 Participants were randomized to receive version #3 of 5 different versions of a message from a physician regarding vaccination. All messages included a statement that the vaccine is very safe and very effective. In Message 3, this statement was followed by a statement that millions of people have already received the COVID-19 vaccine and an explicit recommendation ("I recommend that you get it"). 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):