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 |
|---|---|---|---|---|---|---|---|---|
| Standard Lifestyle Advice | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant). Standard Lifestyle Advice: Standard clinical education is offered routinely by the participant's usual primary care team. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months. | 1 | None | 10 | 167 | 0 | 167 | View |
| Advice Plus Lifestyle Intervention | Primary care-based identification of pre-diabetes and/or type 2 diabetes with standard clinical education (offered by participant's usual primary care providers) and brief lifestyle advice (delivered by a study Research Assistant) Plus access to an intensive group-based lifestyle intervention offered in a community setting. Standard Lifestyle Advice: See "Standard Lifestyle Advice" arm. Advice Plus Lifestyle Intervention: Standard clinical education offered by the participant's usual primary care team. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team. | 0 | None | 10 | 164 | 0 | 164 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hypoglycemia (severe: admitted to hospital, emergency room, or needed assistance by other person) | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Heart attack (myocardial infarction) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Congestive Heart Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Balloon angioplasty or Stenting of coronary arteries (Percutaneous transluminal coronary angioplasty | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | None | View |
| Stroke (transient ischemic attack, cerebral ischemia/hemorrhage, or cerebrovascular accident) | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Cardiac Arryhythmia (atrial fibrillation or flutter) | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |