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 @ 3:57 AM
Ignite Modification Date: 2025-12-26 @ 2:48 AM
NCT ID: NCT00865202
Description: Postoperative Nausea
Frequency Threshold: 0
Time Frame: Postoperative Nausea
Study: NCT00865202
Study Brief: A Placebo Controlled Trial Of L-Tryptophan In Post-Operative Delirium
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Drug L-tryptophan 1 gm enterally TID starting the evening of the operation None None 0 152 0 152 View
Placebo Similar appearing placebo None None 0 149 0 149 View
Serious Events(If Any):
Other Events(If Any):