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 @ 3:38 PM
Ignite Modification Date: 2025-12-25 @ 1:49 PM
NCT ID: NCT01977092
Description: This study did not involve any medications; participants were randomized to a behavioral intervention. No regular assessments of medical adverse events were collected.This study collected information on Serious Adverse Events in a non-systematic assessment. During the follow up interviews, participants would report the number of hospitalizations in the prior 6 months. The interviewer would then collect additional information for reporting of Serious Adverse Events.
Frequency Threshold: 5
Time Frame: Data was collected for participants for 1 year that they participated in the study.
Study: NCT01977092
Study Brief: Reducing Offenders' HIV Risk: MI Enhanced Case Management With Drug-Free Housing
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Motivational Interviewing Case Management MICM intervention combines aspects of motivational interviewing along with case management to influence HIV risk and recovery from alcohol and drug problems. Participants assigned to the MICM condition will be contacted to receive 3 individual sessions within the first 4 weeks of entering the study. Thereafter they will have contact with the MICM therapist monthly throughout the duration of their enrollment in the study (12 months). Motivational interviewing case management 3 None 12 149 0 149 View
Resource Referrals Respondents will receive SLH services as usual along with a list of resources that can be used to address a variety of problems. Resource referrals 4 None 30 181 0 181 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depressive symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal symptoms NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Staph infection NON_SYSTEMATIC_ASSESSMENT General disorders None View
Contusions and lacerations NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cardiac arrhythmia, unspecified NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Alcohol withdrawal NON_SYSTEMATIC_ASSESSMENT General disorders None View
Unspecified asthma with (acute) exacerbation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Fracture NON_SYSTEMATIC_ASSESSMENT General disorders None View
Cerebral infarction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bronchitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Unconsciousness NOS NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gastrointestinal hemorrhage, unspecified NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Acute embolism and thrombosis of unspecified deep veins of lower extremity NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infarction of spleen NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Biliary acute pancreatitis NON_SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Contusions NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):