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 @ 3:19 AM
Ignite Modification Date: 2025-12-26 @ 1:58 AM
NCT ID: NCT00857805
Description: 74 participants at risk
Frequency Threshold: 0
Time Frame: 30 months
Study: NCT00857805
Study Brief: Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Transarterial Chemoembolization Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions. 13 None 8 39 39 39 View
Proton Beam Radiotherapy Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions 16 None 2 35 35 35 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Liver Failure SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI Ulcer SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
GI Bleed SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Erythema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View