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 @ 7:48 PM
Ignite Modification Date: 2025-12-25 @ 5:25 PM
NCT ID: NCT02674503
Description: None
Frequency Threshold: 5
Time Frame: 1 year
Study: NCT02674503
Study Brief: Impact of a Mobility Program
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intensive MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. Walking: MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session. 10 None 36 60 11 60 View
Friendly Visit UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive. Friendly visit: UC patients will receive three times a day "friendly visits", seven days a week by members of the research team to control for the daily attention that MP patients receive. 9 None 27 68 24 68 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Emergency Department visits SYSTEMATIC_ASSESSMENT General disorders None View
Rehospitalization SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
skin irritation SYSTEMATIC_ASSESSMENT General disorders None View