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 @ 4:42 AM
Ignite Modification Date: 2025-12-26 @ 3:44 AM
NCT ID: NCT03139318
Description: The PI must be notified within 24 hours of learning of any serious adverse events, regardless of attribution, occurring during the study. The IRB must be notified within 10 business days of any unanticipated problems involving risk to subjects or others. All other adverse events, such as those that are expected, or are unlikely or definitely not related to the study participation, are to be reported annually as part of regular IRB continuing review.
Frequency Threshold: 0
Time Frame: 90 days (+/- 7 days) post surgery
Study: NCT03139318
Study Brief: Phase I Clinical Trial of GRID Therapy in Pediatric Osteosarcoma of the Extremity
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GRID Radiotherapy Patients will be treated with GRID Radiotherapy GRID radiotherapy: Patients will be treated with GRID radiotherapy 0 None 0 1 1 1 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Surgical wound breakdown (Grade 2) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Surgical wound breakdown (Grade 3) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View