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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT00530803
Description: Skin reactions actively watched for during procedure. No major adverse outcomes, minor site reactions resolved shortly after removal of EMLA.
Frequency Threshold: 0
Time Frame: Investigators monitored for adverse events during procedure and up to 20 minutes after removal of topical anesthetic.
Study: NCT00530803
Study Brief: The Efficacy of EMLA Cream vs. Synera Patch for Pain Reduction During Venipuncture in 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
EMLA Cream Participants will have a dose of EMLA Cream applied to the venipuncture site 1 hour before the procedure. Dosage based on age and weight: 4-6 years old and heavier than 10kg will receive 10g of EMLA; 7-12 years old and more than 20kg will receive 20g of EMLA. EMLA Cream: 60 minutes x1 0 None 0 50 27 50 View
Synera Patch Participants will have a Synera Patch applied to the venipuncture site 20 minutes prior to the procedure. Synera Patch: 20 minutes x1 0 None 0 50 10 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
pallor SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Edema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View