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 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 12:50 AM
NCT ID:
NCT02874534
Description:
Study team members (e.g., study coordinator, study therapists) asked participants at each visit following the initial appointment if any adverse events or changes in health were experienced since the last visit. Adverse Events were assessed by a trained study coordinator, study therapist, or other approved study team member, and discussed at the weekly research staff meetings.
Frequency Threshold:
0
Time Frame:
From initial assessment through post treatment scan, a total of approximately 3 to 5 months.
Study:
NCT02874534
Study Brief:
Development of a Novel Transdiagnostic Intervention for Anhedonia - R61 Phase
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Behavioral Activation | Treatment will consist of 15 weekly 45-minute sessions. Session 1 provides orientation and psychoeducation on anhedonia, and activity monitoring is introduced. Sessions 2-3 include structured values assessments of 10 life areas to enhance motivation for sustained behavior change and to clarify goals. Following goals clarification, an activity hierarchy is developed, establishing a set of idiographic behavioral targets across life areas prioritized by ease of implementation to scaffold task engagement during the course of treatment. Behavioral Activation: Treatment will consist of 15 weekly 45-minute sessions. | 0 | None | 0 | 31 | 10 | 31 | View |
| Mindfulness Treatment | BATA will be compared to mindfulness based cognitive therapy (MBCT), chosen because its mechanisms of action are hypothesized to impact different brain mechanisms than BATA. Mindfulness is nonjudgmentally bringing awareness and acceptance to one's present-moment experience. MBCT will be administered in an individual format. The MBCT protocol will be modeled on the session outlines presented in Wahbeh et al., 2014. Treatment will be compromised of 15 weekly 45-minute sessions. Mindfulness Treatment: Treatment will consist of 15 weekly 45-minute sessions. | 0 | None | 0 | 26 | 12 | 26 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Cold Symptoms | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Intermittent eye twitching | SYSTEMATIC_ASSESSMENT | Eye disorders | None | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Scalp Acne | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Suicidal Ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Telogen Effluvium | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Upper respiratory infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Presyncopal Episode | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Broken Collar Bone | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Streptococcal pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Worsening arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Sinus Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Elevated TSH | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Flu | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hip Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Burns on right forearm | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |