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 @ 3:23 AM
Ignite Modification Date: 2025-12-26 @ 2:01 AM
NCT ID: NCT02040805
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02040805
Study Brief: Comparison of Treatment for Hoarding Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group Cognitive-Behavioral Therapy Sixteen sessions of group therapy facilitated by a psychologist. Group Cognitive Behavioral Therapy: Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing "clutter buddies", and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF. 0 None 0 160 1 160 View
Peer Facilitated Support Group Fifteen sessions of peer-facilitated group support. Peer Facilitated Support Group: Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual. 0 None 0 163 2 163 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Voluntary hospitalization due to "alcohol detox" "possible suicidality" NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidality NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Participant Fell NON_SYSTEMATIC_ASSESSMENT Social circumstances None View