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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT04586569
Description: No adverse events were anticipated as this was a minimal risk study. As such, no adverse events occurred (all recorded deaths and adverse events are currently reported, as below). Adverse event reporting is for the parent/child dyad. The child participants in both groups were observed for preop anxiety and postop emergence delirium yet were not included in other arms of the study and were considered the same dyad with the parent/guardian.
Frequency Threshold: 0
Time Frame: Adverse even data were collected for length of time participants were in the study, which was up to 10 days.
Study: NCT04586569
Study Brief: A Single Blinded Randomized Controlled Trial Testing the Efficacy of a Pediatric Interactive Relational Agent vs. Standard Preoperative Education
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Education This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham. 0 None 0 35 0 35 View
Pediatric Interactive Relational Agent (PIRA) This group will receive the standard of care pre-operative education that all children get prior to ORL surgery at BCH Waltham and will be given access to an interactive, online educational tool for use prior to surgery. This Pediatric Interactive Relational Agent (PIRA) will be able to be accessed as many times as the family would like prior to surgery. Pediatric Interactive Relational Agent (PIRA): The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience. 0 None 0 34 0 34 View
Serious Events(If Any):
Other Events(If Any):