Adverse Events Module

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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

Ignite Creation Date: 2025-12-25 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT04142034
Description: Using standard definitions of adverse events, adverse events were reported during the intervention period. All-cause mortality, serious and other (not including serious) adverse events were not reporting during the recruitment period for those in the consecutive recruitment or traditional recruitment arms.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT04142034
Study Brief: Feasibility Trial of the iAMHealthy Intervention
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
iAmHealthy + Newsletter Behavorial Intervention This intervention will receive the American Academy of Pediatrics (AAP) newsletter, group and individual sessions with the iAmHealthy behavioral intervention team via an electronic tablet provided by the sponsor. the iAmHealthy Behavioral Intervention: iAmHealthy Behavioral Intervention Arm Child/caregiver pairs in the iAmHealthy behavioral intervention arm will receive: * usual care at their clinic for all issues, including overweight and obesity; * a monthly newsletter that focuses on general child health. The child/caregiver pairs will receive six newsletters (one per month) during the six month intervention period (same newsletter provided to the newsletter-only intervention participants); * weekly group sessions for the first three months, followed by monthly group sessions during the next three months, for a total of 15 group sessions. The trial's iAmHealthy behavioral intervention psychologist or social worker (one team per clinic) will deliver these group sessions via an electronic tablet that the trial sponsor will supply; * 11 hours of individual "homework" sessions with the iAmHealthy behavioral intervention dietician 0 None 0 52 1 52 View
NewsLetter Intervention This intervention arm will only receive the American Academy of Pediatrics (AAP) newsletter for six months. Newsletter only arm: Newsletter arm participants will receive a monthly newsletter on maintaining a healthy weight through diet and exercise 0 None 0 52 0 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper limb NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (10.0) View