Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 4:07 AM
Ignite Modification Date: 2025-12-26 @ 3:04 AM
NCT ID: NCT03327220
Description: All-cause Mortality: ITT population included all randomized participants. Serious Adverse Events and Adverse Events: Safety population included all participants who received study treatment.
Frequency Threshold: 5
Time Frame: From first treatment up to the end of the study (Up to approximately 12 weeks)
Study: NCT03327220
Study Brief: Treatment With Iovera° for Total Knee Arthroplasty (TKA) Post-Operative Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Iovera° Device Treatment Group Iovera° device presurgical cryoneurolysis treatment, 5 (+/- 2) days prior to TKA. Additionally, all participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols. 0 None 2 59 4 59 View
Standard of Care Treatment Group All participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols. 0 None 2 60 3 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Bilateral Pulmonary Emboli SYSTEMATIC_ASSESSMENT Vascular disorders None View
R/O Popliteal Arterial Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Neuropsychotic/seizures SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anaphylaxis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
R/O Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View