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 |
|---|---|---|---|---|---|---|---|---|
| App Plus Coaching (AC) | 6 month addiction model based weight loss intervention in the form of an iPhone app coupled with personalized coaching. App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months. Coaching: a. 6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction. b. Daily Weighing c. Daily Text messages from Coach d. Weekly 15 minute phone meetings with Coach e. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent | 0 | None | 0 | 54 | 0 | 54 | View |
| App Alone (AA) | 6 month addiction model based weight loss intervention in the form of an iPhone app. App: a. 6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction b. Daily Weigh In c. App based reminders d. Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months. | 0 | None | 0 | 53 | 0 | 53 | View |
| Clinic | In-Clinic Multi-disciplinary monthly weight management program. Curriculum adapted from the KidsNFitness Program and administered by an MD, RD, Psychologist and Health Educator over 90 minute sessions Clinic: Modified KidsNFitness: a. 6 month in-clinic, evidence-based, multi-disciplinary intervention b. 90 minute sessions, in clinic that occur every month for 6 months c. Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months. | 0 | None | 0 | 54 | 0 | 54 | View |