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 @ 4:05 PM
Ignite Modification Date: 2025-12-25 @ 2:06 PM
NCT ID: NCT01481766
Description: None
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT01481766
Study Brief: Iron Treatment for Young Children With Non-anemic Iron Deficiency
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NAID - Iron plus diet advice From the screening cohort, children with NAID (nonanemic iron deficiency) were invited to participate in an RCT. This group was randomized to receive Ferrous Sulfate 6 mg elemental iron/kg/day in 2 divided doses for four months plus diet advice 0 None 0 28 16 28 View
NAID - Placebo plus diet advice From the screening cohort, children with NAID (nonanemic iron deficiency) were invited to participate in an RCT. This group was randomized to receive Placebo in 2 divided doses for four months plus diet advice 0 None 0 27 7 27 View
IS - Iron sufficient From the screening cohort, a random sample of children with Iron Sufficiency were invited to participate in a prospective observational arm. They received diet advice only. 0 None 0 29 0 29 View
IDA - Iron deficiency anemia From the screening cohort, children with Iron Deficiency Anemia (IDA) were invited to participate in a prospective observational arm. They received usual care, including Ferrous Sulfate 6 mg elemental iron/kg/day in 2 divided doses for four months plus diet advice. 0 None 0 32 16 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Change in stool SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View