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 @ 4:02 PM
Ignite Modification Date: 2025-12-25 @ 2:04 PM
NCT ID: NCT02677766
Description: None
Frequency Threshold: 0
Time Frame: to the end of the study, which means 45 days post hosèital discharge
Study: NCT02677766
Study Brief: Occupational Therapy in Complex Patients: a Pilot Study
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 Intervention of Occupational therapy consists of implementing plans of action focused on the occupational needs chosen by patients through COPM occupational therapy: an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0. 2 None 0 20 0 20 View
Usual Care Usual care consists in rehabilitation treatment delivered by a multidisciplinary team Usual care: Usual care consists in rehabilitation treatment delivered by a multidisciplinary team 2 None 0 20 1 20 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
referred to other wards for clinical reasons SYSTEMATIC_ASSESSMENT Cardiac disorders regular investigator View