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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care Control | Women with pre-diabetes randomized to usual care will be offered 30 minute appointments with a medical provider to review their diagnosis, risk for diabetes, and stress the importance of lifestyle changes to prevent diabetes, including weight loss and exercise and setting individual goals for these. Usual care participants will be encouraged to achieve goals equivalent to the ILI group: to reduce their weight by 7%, and to increase their physical activity to approximately 150 minutes moderate intensity exercise per week. They will be offered a consultation with an FHCHC nutritionist to achieve dietary/weight loss objectives. Participants are offered printed educational materials which are language and literacy-appropriate. | 0 | None | 0 | 61 | 0 | 61 | View |
| Intensive Lifestyle Intervention (ILI) | Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. Intensive Lifestyle Intervention: Women with pre-diabetes randomized to the ILI will attend an intensive 14-week group program of nutritional education, diet, behavior modification and structured exercise, which is based on the published curriculum from the DPP "Lifestyle Balance" program, but modified for a group format and to be more culturally and linguistically appropriate for this population. | 0 | None | 0 | 61 | 0 | 61 | View |