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 @ 4:54 AM
Ignite Modification Date: 2025-12-26 @ 3:54 AM
NCT ID: NCT00385918
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00385918
Study Brief: Robotically Assisted Treadmill Training in Spinal Cord Injury (SCI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lokomat Training Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes. Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis. None None 1 15 5 15 View
Home Stretching Then Lokomat Training Patients will participate in a home stretching program for 3 months. Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.This group will switch to the 3-month robotic intervention after completing the home-based training program. None None 0 6 3 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest and Abdominal Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin abrasion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Urinary Tract Infection (UTI) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Bruise SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
General pain and lethargy SYSTEMATIC_ASSESSMENT General disorders None View
Blood in urine SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Hypotensive response SYSTEMATIC_ASSESSMENT General disorders None View
Significant Weight Loss SYSTEMATIC_ASSESSMENT General disorders None View
Ankle Swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View