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 @ 10:58 PM
Ignite Modification Date: 2025-12-25 @ 8:27 PM
NCT ID: NCT00122369
Description: Adverse event reporting was done using the Reporting Standard of the Society of Interventional Radiology
Frequency Threshold: 1
Time Frame: Patients were followed for up to one week after their biopsy
Study: NCT00122369
Study Brief: Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard of Care As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy. None None 0 76 7 76 View
Empathic Attention The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999) None None 0 82 11 82 View
Self-Hypnotic Relaxation In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script. None None 0 78 3 78 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematoma SYSTEMATIC_ASSESSMENT Surgical and medical procedures SIR Standard View
Vasovagal episode SYSTEMATIC_ASSESSMENT Surgical and medical procedures SIR Standard View
Vomiting SYSTEMATIC_ASSESSMENT Surgical and medical procedures SIR Standard View