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 @ 4:21 PM
Ignite Modification Date: 2025-12-25 @ 2:17 PM
NCT ID: NCT05142566
Description: None
Frequency Threshold: 5
Time Frame: Index procedure up to 30 days
Study: NCT05142566
Study Brief: MANTA Ultrasound Closure Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ultrasound Closure Open label, single arm study using ultrasound guidance during MANTA device deployment. MANTA Vascular Closure Device: Evaluate the safety of ultrasound guided deployment of MANTA VCD. 0 None 2 17 4 17 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Transient Ischemic Attack (TIA) NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Systemic Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Access Site Hematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Edema in left hand NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Retroperitoneal Bleed NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vessel Dissection NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View