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 @ 4:58 AM
Ignite Modification Date: 2025-12-26 @ 3:58 AM
NCT ID: NCT03375918
Description: No adverse events (defined as "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research") were expected or noted among the participating healthcare trainees who received this educational intervention Patients did not have adverse events collected.
Frequency Threshold: 0
Time Frame: 6 months after the intervention
Study: NCT03375918
Study Brief: COmmuNity-engaged SimULation Training for Blood Pressure Control
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthcare Trainees Within each academic year, trainee clusters are assigned1 of 5 start date training times for Other: CONSULT-BP Educational Intervention. Each arm has a pre-intervention (control) period and a post-intervention (exposure) period. CONSULT-BP Educational Intervention: Our intervention comprised two sessions over a 5-week period. The first session focused on (1) didactic overview of healthcare disparities, social drivers of health, implicit bias and systemic racism and (2) interactive discussions and patient storytelling videos to raise awareness of the bi-directional role of racial and ethnic identity among clinicians and patients. The second session focused on skill building and included (1) bias mitigation strategies based on the RELATE bias mitigation tool proposed by Cooper (Cooper L. Why Are Health Disparities Everyone's Problem? . Baltimore: Johns Hopkins University Press; 2021.) and (2) skill practice using 2 standardized patient simulated clinical encounters focusing on hypertension management challenges. The second session lasted 4 hours. Between the two sessions, trainees were asked to complete a race/ethnicity-compliance implicit association test and were provided the results to build self-awareness of potential implicit bias. 0 None 0 118 0 118 View
Patients - Control Arm Patients clustered within trainees in pre-training control period 0 None 0 944 0 944 View
Patients - Intervention Arm Patients clustered within trainees in post-training intervention period 0 None 0 1651 0 1651 View
Serious Events(If Any):
Other Events(If Any):