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 @ 4:46 AM
Ignite Modification Date: 2025-12-26 @ 3:48 AM
NCT ID: NCT01253018
Description: None
Frequency Threshold: 0
Time Frame: 8.5 months
Study: NCT01253018
Study Brief: Evaluation of Robot Assisted Neuro-Rehabilitation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Robot Therapy 12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes None None 3 21 0 21 View
Transition to Task Training 12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT) None None 4 22 2 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Stent Placement NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atrial Fib NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hospitalization to r/o new CVA NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fall at home with resulting fx to study arm NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View