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: 2025-12-24 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT02487251
Description: The definitions did not differ from those described in clinicaltrials.gov
Frequency Threshold: 0
Time Frame: Monitoring adverse events in children occurred across all study years through study completion, an average of 12 weeks from pre-test period, intervention period, post-test period for Phase 1 and an average of 24 weeks from pre-test period, intervention period, to post test period in Phase 2.
Study: NCT02487251
Study Brief: Effectiveness of Differing Levels of Support for Family Mealtimes on Obesity Prevention Among Head Start Preschools
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental: Phase 1 Usual Exposure Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas. Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received 0 None 0 434 0 434 View
Experimental: Phase 1 Mealtime Support Activities Participants will engage in mealtime support activities such as healthy eating classes, cooking demonstrations, provision of cookware, receipt of mealtime ingredients, receipt of prepared meals, make and eat meals). Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period. 0 None 0 65 0 65 View
Experimental: Phase 2- Usual Exposure Participants receive no additional information about healthy eating, family mealtimes, nutrition education or meal planning beyond any usual coverage of these areas. Usual Exposure: Participants receive no supplemental information on family mealtimes beyond what is already currently received 0 None 0 152 0 152 View
Experimental: Phase 2- Meal Delivery and Receipt of Cookware Participants will receive two prepared meals weekly for 12 weeks and will receive a comprehensive set of cookware Mealtime Supports: Participants will receive or engage in a variety of supports for family mealtimes in Phase 1 (e.g., receipt of prepared meals, receipt of cookware, informational supports, classes). In Phase 2 of the study participants received two prepared meals per week for 12 weeks and received a comprehensive set of cookware at the beginning of the intervention period. 0 None 0 159 0 159 View
Serious Events(If Any):
Other Events(If Any):