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 @ 4:43 PM
Ignite Modification Date: 2025-12-25 @ 2:31 PM
NCT ID: NCT04948866
Description: Due to the severity of illness present in the study population, adverse events including mortality and caregiver emotional distress were expected but adjudicated as unrelated to study participation.
Frequency Threshold: 0
Time Frame: Adverse events were collected from when participants entered the study to 60 days post hospital discharge.
Study: NCT04948866
Study Brief: Palliative Care for Persons With Late-stage Alzheimer's and Related Dementias and Their Caregivers
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intervention Condition: ADRD-PC Program (Patients) Patients randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care. 1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams. 2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions. 3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls. 41 None 0 221 0 221 View
Intervention Condition: ADRD-PC Program (Caregivers) Caregivers randomized to the intervention arm received ADRD-PC Program during hospitalization and post-acute care. 1. Dementia-specific palliative care delivered by hospital-based specialty interdisciplinary palliative care teams. 2. Standardized caregiver education will be provided by the palliative care team. Clinicians will share and discuss the booklet Advanced Dementia: A Guide for Families, which addresses common concerns and treatment decisions. 3. Transitional care will be provided by the palliative care team, including facilitation of community-based services and two post-discharge telephone calls. 0 None 0 221 24 221 View
Control Condition (Patients) Patients randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care. 40 None 0 221 0 221 View
Control Condition (Caregivers) Caregivers randomized to the control arm received educational materials from the Alzheimer's Association, specifically designed for late-stage ADRD caregivers. The patients will receive usual hospital and post-acute care. 0 None 0 221 40 221 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Emotional Distress SYSTEMATIC_ASSESSMENT Psychiatric disorders None View