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 @ 9:24 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT05419232
Description: None
Frequency Threshold: 5
Time Frame: 6 weeks
Study: NCT05419232
Study Brief: COVID-19 Vaccine Uptake Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: Call + Call Participants were randomized to Call at timepoint one and Call at timepoint two 0 None 0 56 0 56 View
Group 2: Call + Text Participants were randomized to Call at timepoint one and Text at timepoint two. 0 None 0 63 0 63 View
Group 3: Text + Call Participants were randomized to Text at timepoint one and Call at timepoint two. 0 None 0 52 0 52 View
Group 4: Text + Text Participants were randomized to Text at timepoint one and Text at timepoint two. 0 None 0 71 0 71 View
Group 5: Call Only Participants were randomized to Call at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew. 0 None 0 6 0 6 View
Group 6: Text Only Participants were randomized to Text at timepoint one and did not receive a randomization at timepoint two due to reaching the primary endpoint of vaccination, were lost to follow-up, or the participant withdrew. 0 None 0 3 0 3 View
Serious Events(If Any):
Other Events(If Any):