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 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:33 AM
NCT ID: NCT05941702
Description: No unanticipated adverse events occurred or serious adverse events occurred. One individual reported increased awareness of FND symptoms and associated distress, they chose to drop out of the study and subsequently contacted researchers to inform symptoms had resolved - this was deemed an 'anticipated adverse reaction' to treatment. No further events/reactions occurred during the trial
Frequency Threshold: 0
Time Frame: 3 months
Study: NCT05941702
Study Brief: Body Signal Integration Training: A Case Series
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Full session plan of the 8 sessions is uploaded to documents. This arm will consist of weekly 1 hour 1:1 sessions with Trainee Clinical Psychologist doing exercises aimed at improving interoception. Exercises will include tuning into the body under different circumstances e.g., while having a drink, looking at pictures to induce a positive mood state. Body Signal Integration Training: Information and protocol uploaded to documents. 0 None 0 8 1 8 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Psychological Distress NON_SYSTEMATIC_ASSESSMENT Social circumstances None View