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 @ 3:21 AM
Ignite Modification Date: 2025-12-26 @ 1:59 AM
NCT ID: NCT02165605
Description: Expected adverse event due to radiation with and without the skin cream (Hylacare). * Erythema * Pain * Tenderness * Irritability * Burning * Dryness * Hypersensitivity * Hair loss
Frequency Threshold: 0
Time Frame: The independent panel (two radiation oncologists and two breast surgeons) evaluated photographs of the breasts taken at week 5 during and 2 weeks post-RT
Study: NCT02165605
Study Brief: HylaCare in the Treatment of Acute Skin Changes in Patients Undergoing Radiotherapy for Breast Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Expected Adverse Events With and Without Skin Cream(Hylacare) Expected adverse event due to radiation with and without the skin cream (Hylacare). * Erythema * Pain * Tenderness * Irritability * Burning 0 None 0 28 14 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Desquamation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View