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 @ 4:18 PM
Ignite Modification Date: 2025-12-25 @ 2:15 PM
NCT ID: NCT02812966
Description: Participants asked when they came in if there was an adverse event
Frequency Threshold: 0
Time Frame: In this study we will only be collecting Adverse Events (AEs) related to the procedure or device, unanticipated adverse device effects (UADE), and all Serious Adverse Events (SAEs) from the time of enrollment/randomization through study exit, up to 12 months.
Study: NCT02812966
Study Brief: Lutonix or Inpact for tHE tReatment Of fEmeropopliteal Stenosis - Drug Coated Balloon
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
IN.PACT Drug Coated Balloon IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter IN.PACT: Drug Coated Balloons 0 None 0 17 0 17 View
Lutonix Drug Coated Balloon Lutonix 035 Drug coated Balloon Percutaneous Transluminal Angioplasty Catheter Lutonix: Drug Coated Balloons 1 None 1 18 0 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
subdural hematoma SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):