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 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:56 PM
NCT ID: NCT01672294
Description: None
Frequency Threshold: 5
Time Frame: During time of study participation, 8 weeks per participant. Adverse events were collected both systematically, by asking of events at each time point, and non-systematically.
Study: NCT01672294
Study Brief: Caregiver Outlook: An Intervention to Improve Caregiving in Serious Illness
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Caregiver Outlook - Caregiver Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy. None None 0 71 4 71 View
Caregiver Outlook - Patient Patients of the caregivers in the Outlook Intervention arm. None None 13 71 7 71 View
Relaxation Meditation - Caregiver Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD. None None 0 72 4 72 View
Relaxation Meditation - Patient Patients of the caregivers in the Attention Control arm. None None 11 72 11 72 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Cardiac NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gastro-Intestinal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Renal NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Respiratory NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Neoplasm-death NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Psychiatric NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vascular/blood NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Multiple/general NON_SYSTEMATIC_ASSESSMENT General disorders None View