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 @ 3:03 AM
Ignite Modification Date: 2025-12-26 @ 1:42 AM
NCT ID: NCT02672033
Description: Dose limiting toxicity (DLT) defined as any treatment-related grade 3 or higher toxicity in the following categories: respiratory, upper GI, and cardiac. Also, any other grade 4 or 5 toxicity attributed to the therapy constitutes DLT. All AE's and SAE's, with grade and attribution were submitted to our DSMB as part of our quarterly summary reports. Serious adverse events were also reported individually to the DSMB and, where required, to our UCLA IRB within 2-10 days of awareness.
Frequency Threshold: 5
Time Frame: Adverse event data was collected from 10/2015 until 4/2018, 30 months.
Study: NCT02672033
Study Brief: Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients With Malignant Pleural Mesothelioma
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Hypofractionated IMRT, Pleurectomy/Decortication) Patients undergo 5 fractions of accelerated hypofractionated IMRT over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT. Hypofractionated Radiation Therapy: Undergo accelerated hypofractionated IMRT Intensity-Modulated Radiation Therapy: Undergo accelerated hypofractionated IMRT Laboratory Biomarker Analysis: Correlative studies Therapeutic Conventional Surgery: Undergo pleurectomy/decortication 2 None 2 2 2 2 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (4.0) View
Weakness NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View