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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:03 AM
NCT ID: NCT02266134
Description: Adverse events were only tracked and assessed for patients, not therapists. This was because, to the best of our knowledge, therapists were not likely to experience adverse events, as they were only making changes to their routine clinical practice. Patients, however, all had a depression diagnosis, were receiving clinical care, and were more sensitive to adverse events, such as medical hospitalization, suicidal ideation, or death.
Frequency Threshold: 0
Time Frame: Collected during a client's enrollment in the study (i.e., approximately 12 weeks).
Study: NCT02266134
Study Brief: Standardized Versus Tailored Implementation of Measurement Based Care for Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standardized Implementation, Patients Sites randomized to the standardized condition will be expected to use the Patient Health Questionnaire prior to each session with a depressed client and they will work as a team to maximize fidelity. Sites in this arm will receive the standard implementation of measurement based care intervention. Standard Implementation of Measurement Based Care: measurement based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire (PHQ-9), the implementation of measurement based care will be standardized such that clinicians will be encouraged to administer the PHQ-9 to depressed clients before each session 0 None 5 141 0 141 View
Tailored Implementation, Patients Sites randomized to the tailored condition will develop a site-specific protocol for use of the Patient Health Questionnaire and they will work as a team to maximize the fit of measurement based care to this clinic. Sites in this arm will receive the tailored implementation of measurement based care intervention. Tailored Implementation of Measurement Based Care: measurement based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire, the implementation of measurement based care will be tailored based on clinic specific barriers and facilitators 1 None 8 87 1 87 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Medical Hospitalization NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Death NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inappropriate Behavior Toward Staff NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View