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: 2025-12-26 @ 5:24 PM
Ignite Modification Date: 2025-12-26 @ 5:24 PM
NCT ID: NCT03883906
Description: All adverse events that occur from the administration of first VST infusion through 30 days after the last VST infusion were recorded per the protocol. Events occurring greater than 30 days after the last VST infusion were assessed and recorded only when they are unexpected and determined to be at least possibly related to the VST infusion through 1 year after the last VST infusion.
Frequency Threshold: 0
Time Frame: 30 days
Study: NCT03883906
Study Brief: Donor-Derived Viral Specific T-cells (VSTs) for Prophylaxis Against Viral Infections After Allogeneic Stem Cell Transplant
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Viral Specific T-cells (VSTs) Viral Specific T-cells (VSTs): VSTs will be infused into stem cell transplant recipients 2 None 0 23 1 23 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GVHD, skin SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders CTCAE (5.0) View
GVHD, stomach SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View
GVHD, sigmoid colon & rectum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View