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 @ 10:14 PM
Ignite Modification Date: 2025-12-25 @ 7:48 PM
NCT ID: NCT01797835
Description: Adverse Event (AE): any untoward medical occurrence that may present itself during treatment or administration of an intervention, and which may or may not have a causal relationship with the treatment. Adverse events could arise from the study (e.g., breach of confidentiality) or could arise due to the population under study (e.g., a youth reports extensive use of drugs or that he/she "huffs" daily).
Frequency Threshold: 0
Time Frame: 12 months
Study: NCT01797835
Study Brief: Alcohol Screening in an Ethnically Diverse Sample of Adolescents in Primary Care
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Usual Care Youth in usual care will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. They will also receive an informational brochure. usual care: Youth receive a brochure with information on AOD use. 0 None 0 141 0 141 View
CHAT Brief MI Intervention Youth in CHAT will receive screening for alcohol and drug use. Those youth who are at risk will have a chance to talk to their provider about their use. In addition, these youth will CHAT. CHAT is a brief motivational intervention that takes places in the primary care setting. It is a 15-20 minute intervention for adolescents age 12-18 focused on discussing alcohol and drug use. They will also receive a booster call one month later to check in on how they are doing. CHAT brief MI intervention: CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care. 0 None 0 153 0 153 View
Serious Events(If Any):
Other Events(If Any):