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 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
NCT ID:
NCT04426318
Description:
Anxiety and depression scores were characterized separately at T1 (baseline), T5 (4 weeks), and T6 (16 weeks) based on normative none-to-slight, mild, moderate, and severe symptoms from PROMIS anxiety and PROMIS depression scores (i.e., T-score \<55, 55≥ \<60, 60≥ \<70, and ≥70; Pilkonis et al., 2011).
Frequency Threshold:
0
Time Frame:
up to 16 weeks
Study:
NCT04426318
Study Brief:
COVID-19 and the Healthy Minds Program for Educators
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Healthy Minds Program Foundations Training | Healthy Minds Program (HMP) is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. All program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). In addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine. | 0 | None | 0 | 344 | 344 | 344 | View |
| Wait-list Control | Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing. | 0 | None | 0 | 318 | 318 | 318 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| None to Slight Depression at Baseline | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mild Depression at Baseline | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Moderate Depression at Baseline | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Severe Depression at Baseline | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| None to Slight Depression at 4 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mild Depression at 4 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Moderate Depression at 4 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| None to Slight Depression at 16 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mild Depression at 16 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Moderate Depression at 16 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Severe Depression at 16 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mild Anxiety at Baseline | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Moderate Anxiety at Baseline | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Severe Anxiety at Baseline | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Moderate Anxiety at 4 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Severe Anxiety at 4 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| None to Slight Anxiety at 16 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mild Anxiety at 16 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Moderate Anxiety at 16 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Severe Depression at 4 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| None to Slight Anxiety at Baseline | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| None to Slight Anxiety at 4 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Mild Anxiety at 4 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Severe Anxiety at 16 weeks | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |