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 @ 12:15 AM
Ignite Modification Date: 2025-12-25 @ 10:17 PM
NCT ID: NCT03233958
Description: Two items were developed by the investigators to screen for adverse outcomes: "Have you experienced any negative change in relation to your mental or physical health during or since the family constellation workshop?". If respondents answered affirmatively, it was also asked if they believed the changes were associated with the intervention (yes/no/unsure). Below we report all adverse events, including those participants were sure were not related to the intervention.
Frequency Threshold: 0
Time Frame: 6 months postintervention
Study: NCT03233958
Study Brief: The Psychosocial Effects of Systemic / Family Constellation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Workshop Participants Participants of systemic / family constellation workshops 0 None 0 102 17 102 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Negative mental health outcomes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Negative physical health outcomes NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Combined mental and physical negative outcomes NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View