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 @ 4:50 AM
Ignite Modification Date: 2025-12-26 @ 3:51 AM
NCT ID: NCT03998618
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected on each participant from the point of baseline until approximately 8 months post-baseline.
Study: NCT03998618
Study Brief: Telephone Support for Metastatic Breast Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Acceptance and Commitment Therapy Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue. Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices. 7 None 7 116 0 116 View
Education/Support Patients in the education/support arm will discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework. 11 None 11 120 0 120 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Deaths NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):