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 |
|---|---|---|---|---|---|---|---|---|
| Positive Activities (PA) | Positive Activities (PA) Program: PA activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The intervention was an individually-based program in which participants completed one new positive psychological activity for the first 5 weeks and repeated their favorite in week 6. Activities, which were adapted for the target population, included recalling and reflecting on positive events; writing a letter of gratitude; cultivating mindfulness; practicing kindness; and increasing engagement in activities that they enjoy, give them a sense of achievement, or bring them closer to others (a variant of behavioral activation). | 1 | None | 12 | 180 | 0 | 180 | View |
| Attention Control (AC) | Attention Control (AC) Program: AC activities were delivered using a combination of activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. The booklet contains all instructions patients need to complete the full program. The 6-week program consisting of at-home activities (1 completed per week) are based on affectively neutral activities from control conditions in prior studies of positive activities interventions. The control program was identical to the intervention in terms of framing, reading level, format, duration, and delivery, but contained neutral control activities adapted from previous positive psychological intervention studies. Control activities asked participants to recall events that affected them each day, identify ways they could change their life circumstances, recall early memories, record things they did in the past week, plan their day, and repeat their favorite activity in week 6. | 1 | None | 8 | 180 | 0 | 180 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hospitalizations unrelated to the study | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |