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: 2025-12-24 @ 10:10 PM
Ignite Modification Date: 2025-12-25 @ 7:45 PM
NCT ID: NCT01799135
Description: Serious Adverse Events (SAE's) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term
Frequency Threshold: 0
Time Frame: Up to 4 months
Study: NCT01799135
Study Brief: Feasibility Study of Enhanced MRI for Early Stage Non Small Cell Lung Cancer (NSCLC)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Experimental Arm Stereotactic Body Radiation Therapy: either 54 Gy in 3 fractions or 50-60 Gy in 5 fraction over a span of 15 days at most. DCE-MRI was performed at four time points during therapy: at baseline prior to SBRT, 1-2 days after the first treatment fraction, 1-2 weeks after the end of the SBRT course, and 3 months after completing radiotherapy. 4D-CT scan 3 months after completing radiotherapy. DCE-MRI scan Stereotactic Body Radiation Therapy 4D-CT scan 1 None 1 6 2 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Death NOS SYSTEMATIC_ASSESSMENT General disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders CTCAE (4.0) View
Lung Infection SYSTEMATIC_ASSESSMENT Infections and infestations CTCAE (4.0) View