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 @ 3:07 PM
Ignite Modification Date: 2025-12-25 @ 1:28 PM
NCT ID: NCT04240392
Description: None
Frequency Threshold: 5
Time Frame: 52 weeks
Study: NCT04240392
Study Brief: Treatment of Pregnant Women With OUD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Collaborative Care (CC) The CC team includes an obstetrical provider and a nursing case manager. The obstetrician will see all participants, initially to discuss preferences for addiction treatment, buprenorphine, methadone (MAT) or no MAT. The obstetrician will see participants every 1-2 weeks, as needed and will provide prenatal care. The care team will meet at least monthly and review the participants' status. For research purposes, the CM will obtain informed consent, collect and enter results of the urine drug screen (UDS) into a database. At enrollment and at 26 and 34 weeks' gestation participants will complete an assessment battery of self-reported measures. Collaborative Care (CC): The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as "initiation" rather than "induction") and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an "app" that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner. 0 None 22 126 0 126 View
Extension for Community Healthcare Outcomes (ECHO) ECHO is a remote education model that provides mentorship and guided practice and participation in a learning community, via video conferencing. The practice members who participate in ECHO will include obstetricians and nurses as well as other members of the care team who wish to join. Providers are given access to a password-protected website containing the recorded sessions, a discussion board, and resource library. CME credits are available for each session and can motivate providers to attend. Extension for Community Healthcare Outcomes (ECHO): The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions. 0 None 18 102 0 102 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Residential treatment admission SYSTEMATIC_ASSESSMENT General disorders None View
Premature rupture of membranes SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Short Cervix effecting pregnancy SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Fetal demise SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Thrombotic stroke SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Necrotizing Pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hospitalization for opioid withdrawal SYSTEMATIC_ASSESSMENT General disorders None View
Drug overdose SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):