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 @ 3:49 AM
Ignite Modification Date: 2025-12-26 @ 2:36 AM
NCT ID: NCT04047602
Description: Adverse events reported are those that are related to the SRS treatment and are as of February 2024. Patients are still on follow-up for the study and treatment-related adverse events can still occur. Patients were considered at risk for an adverse event if they started SRS treatment. For all-cause mortality and serious adverse events, treatment attribution was not considered.
Frequency Threshold: 5
Time Frame: Up to 28 Months
Study: NCT04047602
Study Brief: Radiosurgery Dose Reduction for Brain Metastases on Immunotherapy (RADREMI): A Prospective Pilot Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Reduced Dose Stereotactic Radiosurgery With Immunotherapy Subjects will receive one stereotactic radiosurgery (SRS) treatment at a reduced dose based on the brain tumor size concurrently with their standard of care immunotherapy. Subjects will undergo follow up with clinical exams and brain MRI scans at 1, 3, 6, 9, and 12 months post SRS treatment Reduced Dose SRS: Subjects will receive SRS treatment at a reduced dose based on the brain tumor size 1 None 1 18 7 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE (5.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE (5.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE (5.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE (5.0) View