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 |
|---|---|---|---|---|---|---|---|---|
| PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth) | Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. PREVENT: Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care. | 0 | None | 36 | 78 | 0 | 78 | View |
| EUC (Enhanced Usual Care) | In-home diabetes education with no goal stetting or telehealth visits | 1 | None | 39 | 78 | 0 | 78 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastrointestinal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Cardiac | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Diabetes-related | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| metabolic-not diabetes related | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | None | View |
| Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| COPD | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| musculoskeletal | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| Blood disorders | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Neurological (excluding stroke) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| psychiatric | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Respiratory | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| shortness of breath | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| renal | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Pulmonary | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Surgical | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |