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 @ 7:23 PM
Ignite Modification Date: 2025-12-25 @ 5:03 PM
NCT ID: NCT05257603
Description: clinicaltrials.gov definitions were used.
Frequency Threshold: 0
Time Frame: Adverse events were assessed over the duration of the study from baseline through 6-month follow-up assessment (an average of 6 months) for each participant.
Study: NCT05257603
Study Brief: Prevention of Alcohol-related Sexual Revictimization in College
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Revictimization Prevention for College Women (RPCW) Active intervention that includes information to reduce hazardous drinking and increase sexual assault risk perception. RPCW: Psychosocial intervention that includes two in-person group sessions two weeks apart and two on-line units during the intervening two weeks. Behavioral training, educational materials, discussions and videos, as well as interactive online materials are included to increase awareness of sexual assault cues, dating and drinking protective behavioral strategies, barriers to defending oneself, and saying no to hazardous drinking and sexual advances. 0 None 0 37 0 37 View
Health Education Control (HEC) Time and attention control. HEC: Health Education time and attention control that includes two in-person sessions two weeks apart and two on-line units during the intervening two weeks. The in-person sessions cover stress management and sleep, while the online units cover nutrition and physical activity. The in-person and online sessions are designed to foster discussion and be interactive. 0 None 0 35 0 35 View
Serious Events(If Any):
Other Events(If Any):