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 @ 1:46 AM
Ignite Modification Date: 2025-12-26 @ 12:05 AM
NCT ID: NCT04506294
Description: Adverse Event definition is same as clinicaltrials.gov definition
Frequency Threshold: 0
Time Frame: 12 weeks
Study: NCT04506294
Study Brief: Evaluating an eHealth Solution for Screening in Pediatric Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
eScreen Group Ill/injured child and one parent are enrolled in the study. After randomization at baseline, child and parent each use the eScreen system (child: game with screening component; parent: information component) for 6 weeks. eScreen system: The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents. 0 None 0 214 0 214 View
Usual Care Group Ill/injured child and one parent are enrolled in the study. Treatment as usual from baseline to 12 weeks. After completion of T3 assessment (\~12 weeks), child is given the option of accessing the game only (no screening). No parent information component is provided. 0 None 0 106 0 106 View
Serious Events(If Any):
Other Events(If Any):