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 @ 7:51 PM
Ignite Modification Date: 2025-12-25 @ 5:26 PM
NCT ID: NCT03962504
Description: None
Frequency Threshold: 1
Time Frame: 30 weeks
Study: NCT03962504
Study Brief: Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Written Exposure Therapy The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant. trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. 0 None 4 88 6 88 View
Prolonged Exposure Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. 0 None 7 90 5 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
medical hospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
medical hospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
psychiatric hospitalization SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
contracted COVID-19 SYSTEMATIC_ASSESSMENT Immune system disorders None View