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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:57 AM
NCT ID: NCT03866902
Description: Both the mother and child were monitored for 4 years for the duration over which adverse events were monitored/assessed
Frequency Threshold: 0
Time Frame: 15 months
Study: NCT03866902
Study Brief: Healthy Mothers-Healthy Children Nutrition
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Nutrition and Physical Activity Intervention-Mother Classes for the intervention mothers will be run by a bilingual interventionist and will last 105 minutes weekly for 12 weeks and then monthly for 6 months. 0 None 0 144 0 144 View
English for Second Language Intervention-Mother Mothers in the control group will receive English as a Second Language (ESL) classes taught by professional ESL teachers; they will receive the same number of contacts and time as the intervention group mothers for 105 minutes weekly for 12 weeks and 105 minutes monthly for 6 months. 0 None 0 143 0 143 View
Nutrition and Physical Activity Intervention-Child Classes for intervention group children will be 105 minutes weekly for 12 weeks and then monthly for 6 months. 0 None 0 144 0 144 View
English for Second Language Intervention-Child Children in the control group will be read to and color with crayons 105 minutes weekly for 12 weeks and then 105 minutes monthly for 6 months. 0 None 0 143 0 143 View
Serious Events(If Any):
Other Events(If Any):