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 @ 9:19 PM
Ignite Modification Date: 2025-12-25 @ 7:06 PM
NCT ID: NCT02760004
Description: None
Frequency Threshold: 0
Time Frame: 37 months - throughout the enrollment period
Study: NCT02760004
Study Brief: PRogram In Support of Moms: An Innovative Stepped-Care Approach for Obstetrics and Gynecology Clinics
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
MCPAP for Moms MCPAP for Moms Access to MCPAP for Moms: • 30-60 minute presentation on perinatal depression * Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns * Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation * Access to assessment and treatment protocols in Provider Toolkit * Resource provision/referrals 0 None 0 162 1 162 View
PRISM Intervention PRogram In Support of Moms (PRISM) PRogram In Support of Moms (PRISM): • Access to MCPAP for Moms * PRogram In Support of Moms Toolkit with Stepped Care Algorithms * Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform * Customization of depression screening for each practice * Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS) * Employ psychoeducation and Motivational Interviewing to engage patients with depression * medical assistant champion and psychiatrist contact bi-weekly to review cases * Stepped care treatment to depression screening/assessment 0 None 0 150 0 150 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospitalization for suicidal risk SYSTEMATIC_ASSESSMENT Psychiatric disorders None View