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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Adaptive Disclosure for Moral Injury and Loss | AD-MIL is a manualized, 12-session individual psychotherapy designed to improve functioning and to reduce PTSD symptoms by facilitating Veterans doing corrective things in their life to heal and repair traumatic loss and moral injuries. The change agents are: (1) emotional-processing of traumatic loss and moral injuries and motivating a healing and action plan by writing therapeutic letters (e.g., to a lost unit member, to victims of personal transgressions, to people who transgressed); (2) skills training and behavioral contracting to improve functioning and targeting moral injury- and traumatic loss-related psychological and behavioral obstacles to positive and potentially habilitative engagements in occupational, relationship, and family roles; and (3) teaching self- and other-compassion and mindfulness. The goal is to redress the functional impact of moral emotions (anger, shame). | 0 | None | 1 | 89 | 7 | 89 | View |
| Present Centered Therapy | PCT is a manualized evidenced-based PTSD treatment used in several large-scale PTSD trials. It incorporates the essential therapeutic elements common to different types of psychotherapies, including supportive empathic listening and unconditional positive regard. The therapist plays an active role, but does not impart any systematic training. The focus is to create an understanding of how the symptoms of PTSD are related to day-to-day difficulties and to help patients develop new, more adaptive responses to these stressors with a problem-focused and problem-solving approach. In prior trials, PCT showed equivalent change to active therapies at the last follow-up. The VA offers PCT as an evidence-based therapy for PTSD. Present Centered Therapy: Participants randomized to the PCT arm will receive 12 sessions of therapy focused on problems occurring in the present (with no focus on trauma or re-visiting past experiences). | 0 | None | 2 | 85 | 10 | 85 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization due to hypertension/elevated heart rate | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Pt relapsed on alcohol and self-admitted to a 30-day rehabilitation program | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Right small toe was amputated due to an infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Increase in psychiatric symptoms | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |