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 @ 1:34 AM
Ignite Modification Date: 2025-12-25 @ 11:48 PM
NCT ID: NCT00858494
Description: Parents noted any adverse events after each dose of study medication in study logs that were returned to the research staff. Data on any adverse event were based on information in study logs returned in 37 of 49 participants. Parents were instructed to call research team if a serious adverse event occurred; data on all 49 participants presented.
Frequency Threshold: 0
Time Frame: up to 10 days after the index visit
Study: NCT00858494
Study Brief: Homeopathic Cold Medicine for 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
Homeopathic Cold Remedy Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms None None 0 49 2 37 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
excessive gas SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View