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 @ 4:19 AM
Ignite Modification Date: 2025-12-26 @ 3:20 AM
NCT ID: NCT03951220
Description: The intention of this study was to assess the value of disease assessment of candidate biomarkers (using DW-MRI and analysis of peripheral blood). Therefore, all-Cause Mortality, Serious, and Other \[Not Including Serious\] Adverse Events were not monitored/assessed.
Frequency Threshold: 0
Time Frame: The intention of this study was to assess the value of disease assessment of candidate biomarkers (using DW-MRI and analysis of peripheral blood). Therefore, all-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.
Study: NCT03951220
Study Brief: The Development and Pilot Testing of a New MR Imaging Protocol to Quantify Myeloma Disease Burden and Bone Loss
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1- Myeloma Participants recruited with myeloma 0 None 0 0 0 0 View
Group 2- MGUS Participants recruited with MGUS 0 None 0 0 0 0 View
Group 3- Healthy Volunteers Participants recruited as healthy volunteers 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):