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 @ 11:56 PM
Ignite Modification Date: 2025-12-25 @ 9:53 PM
NCT ID: NCT04040751
Description: None
Frequency Threshold: 0
Time Frame: Information on adverse events was collected beginning when the study intervention began through the final study assessment at 2 months post-intervention.
Study: NCT04040751
Study Brief: Carepartner Collaborative Integrated Therapy in Sub-Acute Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CARE-CITE Carepartner Carepartners receiving the CARE-CITE intervention 0 None 0 17 0 17 View
Control Carepartners Carepartners receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention 0 None 0 6 0 6 View
CARE-CITE Stroke Survivor Stroke survivors of carepartners receiving the CARE-CITE intervention 0 None 2 17 2 17 View
Control Stroke Survivors Stroke survivors receiving customary care outpatient rehabilitation therapy but no CARE-CITE intervention 0 None 0 6 0 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Fall requiring hospitalization (unrelated to study intervention) NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Stroke (unrelated to study intervention) NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall without injury (unrelated to study intervention) NON_SYSTEMATIC_ASSESSMENT General disorders None View