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 @ 5:01 AM
Ignite Modification Date: 2025-12-26 @ 4:02 AM
NCT ID: NCT02777918
Description: self-report questionnaire assessing number of unusual experiences of nausea, digestive issues (e.g. constipation or diarrhoea), stomach aches/cramps, hunger, bloating/uncomfortable fullness, thirst, headaches, fatigue/tiredness, restlessness, dizziness, or skin rashes.
Frequency Threshold: 0
Time Frame: 6 months
Study: NCT02777918
Study Brief: Changing Habits and Lifestyles in Older Individuals
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention 6 recipes will be sent by post every 2 weeks for a 12 week period. Dietary recommendations will also be provided at the start of the intervention period to increase the relevance of the recipes. Recipe provision: 6 recipes will be provided every 2 weeks by post for 12 weeks 0 None 0 53 53 53 View
Control Dietary recommendations will be provided at the start of the study period, such that the intervention regards the recipes, not the recommendations 0 None 0 47 47 47 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Questionnaire self-report SYSTEMATIC_ASSESSMENT General disorders None View