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 @ 11:49 PM
Ignite Modification Date: 2025-12-25 @ 9:43 PM
NCT ID: NCT02095951
Description: Elevation of ALT, AST from baseline; CVC line breakage, malfuntion, or thrombosis; Reinfection of line within 14 days after line.
Frequency Threshold: 0
Time Frame: Each participant was assessed for Adverse Events for up to 30 days post ELT receipt. (1 participant with 2 distinct episodes of catheter infection was enrolled twice in each group.)
Study: NCT02095951
Study Brief: Preemptive Ethanol Lock Therapy in Pediatric Bloodstream Infection
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm 1 Study Arm, given pre-emptive ELT 0 None 0 4 0 4 View
Arm 2 Study Arm, given standard of care 0 None 0 8 0 8 View
Serious Events(If Any):
Other Events(If Any):