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 @ 3:26 AM
Ignite Modification Date: 2025-12-26 @ 2:07 AM
NCT ID: NCT04179305
Description: For the purpose of this study, an AE is defined as a participant experiencing severe psychological distress, regardless of attribution. Serious Adverse Events (SAEs) were not monitored or assessed. All-Cause Mortality and Other \[Not Including Serious\] Adverse Events were not monitored/assessed for physician participants.
Frequency Threshold: 0
Time Frame: 2 years, 1 month
Study: NCT04179305
Study Brief: Giving Information Systematically and Transparently in Lung and GI Cancer Phase 2
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Oncolo-GIST Arm - Patients Patients assigned to this arm will discuss scan results revealing progressive disease with an Oncolo-GIST trained physician. Oncolo-GIST: Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in "gist communication" by itemizing 4 key steps in the process of imparting prognostic information. Topics covered include: Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying "average life-expectancy is months…" with emphasizing that the oncology team "will always provide care for you") Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis. 1 None 0 0 0 19 View
Usual Care Arm - Patients Patients assigned to this arm will will discuss scan results revealing progressive disease with a physician that was not trained with the Oncolo-GIST intervention. Usual Care Arm: Oncologists will provide care in non-specific manner. 1 None 0 0 0 14 View
Oncolo-GIST Arm - Physicians Physicians assigned to this arm will receive the Oncolo-GIST training intervention. 0 None 0 0 0 0 View
Usual Care Arm - Physicians Physicians assigned to this arm will not receive the Oncolo-GIST training intervention. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):