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 |
|---|---|---|---|---|---|---|---|---|
| Full Version of the LIITah App. (Adolescents) | Participants will be given the LIITAH app. which consists of 1) enhanced location identification (ELI), 2) self reported nutrients by annotated photos (SNAP), 3) delivery of individually and culturally tailored point of purchase (POP) prompts along with tailored messages sent at other times of the day, 4) use of app. in connection with parents, 5) goal setting, 6) a point system Full version of the LIITah App.: Participants will download the LIITAH app. For the first 2 weeks the app. will only record presence in a restaurant and ask users to submit photos of their food. in week 3 all of the program features will be activated. | 0 | None | 0 | 52 | 0 | 52 | View |
| Full Version of the LIITah App.(Parents) | Parents of adolescents who received the LIITAH app. | 0 | None | 0 | 52 | 0 | 52 | View |
| Partial App. (ELI and SNAP Only) (Adolescents) | Participants will be given only the ELI and SNAP components. It will detect their presence in a restaurant and allow users to document their purchases by submitting annotated photos, but it will not deliver any POP prompts encouraging them to make healthy choices, or messages at other times of the day. Partial App. (ELI and SNAP only): Participants will download the LIITAH app. It will detect their presence in a restaurant and users will submit annotated photos of their purchases | 0 | None | 0 | 26 | 0 | 26 | View |
| Partial App. (ELI and SNAP Only) - Parents | Parents of adolescents who received the ELI and SNAP components. | 0 | None | 0 | 52 | 0 | 52 | View |