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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:47 AM
NCT ID: NCT04824560
Description: As the intervention was a survey and phone call, no serious adverse events were expected and none were reported by participants within one week; 4 weeks, or 8 weeks,or when contacted to ensure information would be mailed back at up to 4 weeks after the final phone call (within a maximum of 12 weeks of enrollment).
Frequency Threshold: 0
Time Frame: After enrollment, packet was mailed to participant and future phone call time frames set up to be able to call the participants back for an initial call to ensure packet received within one week of enrollment; with follow-up at 4 weeks after enrollment, 8 weeks after enrollment, and then a final phone call to ensure information would be mailed back at up to 4 weeks after the final phone call.
Study: NCT04824560
Study Brief: Evaluating the Effect of an Evidence-Based One Page With Supplemental Visual Aids on the Knowledge and Perceptions of Blood Pressure Management Among Adults With Hypertension
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
BP Education All participants enrolled receive blood pressure education. Blood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up 0 None 0 5 0 5 View
Serious Events(If Any):
Other Events(If Any):