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 |
|---|---|---|---|---|---|---|---|---|
| Facebook Group | The intervention arm consists of evidence-based information on healthy family routines and parenting strategies (i.e., nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep) adapted for Facebook posts on a private study Facebook group. All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study. | 0 | None | 0 | 23 | 0 | 23 | View |
| Text Messaging (SMS) Group | The intervention consists of evidence-based information on healthy family routines and parenting strategies adapted for 140-character text messages. The automated text-messaging algorithm consists two types of messaging: 1-way messages containing education or motivation on the dimension topic that one is being coached on and 2-way messages, in which participants are able to respond to an educational message containing a number response prompt that will provide them with personalized feedback regarding a dimension they are being coached on. All index children were provided with a Physical Activity Monitor (Fitbit Zip) to wear during waking hours for the duration of the study. | 0 | None | 0 | 24 | 0 | 24 | View |