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 @ 9:20 PM
Ignite Modification Date: 2025-12-25 @ 7:07 PM
NCT ID: NCT02323204
Description: Adverse Events were not assessed (e.g., "All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed.").
Frequency Threshold: 0
Time Frame: Adverse Events were not assessed (e.g., "All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.").
Study: NCT02323204
Study Brief: PCORI-1306-02918 Evaluation of Parent-based Programs to Support Children After Traumatic Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Link: Child Participants Participants of this group were injured children who completed a baseline questionnaire and whose parents received "Link for Injured Kids: Psychological First Aid", an in-person training in key intervention communication skills from a trained interventionist. 0 None 0 0 0 0 View
Link: Parent Participants Participants of this group completed a baseline questionnaire and received "Link for Injured Kids: Psychological First Aid", an in-person training in key intervention communication skills from a trained interventionist. 0 None 0 0 0 0 View
Trauma Education: Child Participants Participants of this group were injured children who completed a baseline questionnaire and whose parents received the trauma education booklet, "So you've been in an accident". 0 None 0 0 0 0 View
Trauma Education: Parent Participants Participants of this group completed a baseline questionnaire and received the trauma education booklet, "So you've been in an accident". 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):