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 @ 1:39 AM
Ignite Modification Date: 2025-12-25 @ 11:55 PM
NCT ID: NCT02370394
Description: The DSMB decided that the following would be included as SAEs: any serious/life threatening threats of intimate partner violence, rape, sexual assault, emergency room visits as well as death, hospitalization, and life-threatening events, as described in the clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: Adverse event data were collected between the date of the baseline and the 3 month follow-up, generally for 3 months, depending on when the participant's 3 month follow-up actually occurred.
Study: NCT02370394
Study Brief: Intervention for IPV Perinatal Women- RCT
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
ROSE Program Participants received a 50-minute intervention on the Tablet PC immediately after their baseline assessment and an in-person 30-minute booster session conducted by interventionists within a month after the intervention. There was also a follow-up assessment 3 months after completion of the ROSE program. ROSE Program: The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was also tailored on the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV. 0 None 9 28 0 28 View
Control Condition Control Condition consisted of a series of questions regarding television show preferences and viewing a brief series of videos of popular entertainers/shows, with subsequent requests for ratings of subjective preference. Participants in this condition completed a baseline assessment as well as a follow-up assessment 3 months later. 0 None 6 25 0 25 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hospitalization-general medical issue NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hospitalization-inpatient-psyc NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
IPV-no medical care NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
IPV related emergency room visit NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):