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 |
|---|---|---|---|---|---|---|---|---|
| Healthy Start to Feeding Intervention | Participants and their parents will participate in a 3 session intervention targeting healthy introduction of complementary foods. Intervention sessions will occur when the infant is 4, 6, and 9 months of age. Healthy Start to Feeding: The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding. | 0 | None | 0 | 17 | 0 | 17 | View |
| Control | Participants and their parents will complete pre- and post-treatment period study visits to assess study outcomes. They will receive no intervention. | 0 | None | 0 | 17 | 0 | 17 | View |