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 @ 7:34 PM
Ignite Modification Date: 2025-12-25 @ 5:15 PM
NCT ID: NCT02998203
Description: All-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed. Based on the study design and the inclusion/exclusion criteria no adverse events were expected and no adverse events were reported during the study period (up to 80 days).
Frequency Threshold: 0
Time Frame: None
Study: NCT02998203
Study Brief: Organic Diet Intervention in Primary School Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1 Schools in Group 1 began first with the organic period and continued with the conventional period. The organic period was organized in two 20-day cycles with differences in the menu to allow for greater variety in the meals, so that the participants' compliance to the organic treatment would be enhanced. During the organic period, participants were asked to strictly follow the two 20-day organic dietary menus provided to them for a total of 40 days. During the conventional period, participants were asked to maintain their usual dietary habits and choices (\>80% conventional diet) for a total of maximum 40 days. 0 None 0 0 0 0 View
Group 2 Schools in Group 2 began first with the conventional period and then switched to the organic period. During the conventional period, participants were asked to maintain their usual dietary habits and choices (\>80% conventional diet) for a total of maximum 40 days. The organic period was organized in two 20-day cycles with differences in the menu to allow for greater variety in the meals, so that the participants' compliance to the organic treatment would be enhanced. During the organic period, participants were asked to strictly follow the two 20-day organic dietary menus provided to them for a total of 40 days. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):