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 |
|---|---|---|---|---|---|---|---|---|
| P3-T PrEP Adherence App | P3-T provided daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that included daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a "bank account" that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that included a user-selected avatar. Intended app use included, at a minimum, participant completion of selected app activities (medication tracking, daily quest, social wall post) each day for the 3-month intervention period. Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit. | 0 | None | 0 | 30 | 0 | 30 | View |
| Standard of Care | Participant completion of Standard of Care PrEP adherence and sexual risk behavior counseling at the 1-month post-prescription visit and the 4-month post-prescription visit. | 0 | None | 0 | 30 | 0 | 30 | View |