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 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:40 PM
NCT ID: NCT02104167
Description: Any change from baseline in a subject's condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
Frequency Threshold: 5
Time Frame: Date of surgery through last follow up visit, mean of 20.7 months
Study: NCT02104167
Study Brief: Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Operated Subjects With ROI-C Device Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit. 0 None 2 110 42 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pseudoarthrosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Cervical stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upper extremity pain/numbness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fall/Injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lower back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Shoulder injury SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View