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 @ 6:40 PM
Ignite Modification Date: 2025-12-25 @ 4:11 PM
NCT ID: NCT05021757
Description: In the CathPCI registry data collection form, intra- and post-procedure adverse events are captured in a pre-specified list. Information on procedure and device-relatedness, as well as serious or non-serious designation, is not captured in the registry.
Frequency Threshold: 1
Time Frame: Up to hospital discharge, approximately 24-48 hours
Study: NCT05021757
Study Brief: Disrupt CAD III Post-Approval Study (PAS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Disrupt CAD III PAS Cohort Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort. A minimum of 150 patients with 30-day follow-up will be included in the PAS cohort. Shockwave C2 Coronary IVL: PCI procedure using a Shockwave C2 coronary IVL catheter 3 None 35 1212 0 1212 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Significant Coronary Artery Dissection (C and above) SYSTEMATIC_ASSESSMENT Cardiac disorders ACC NCDR, SNOMED CT View
Bleeding - Access Site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ACC NCDR, SNOMED CT View
Bleeding - Gastrointestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ACC NCDR, SNOMED CT View
Bleeding - Hematoma at Access Site SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ACC NCDR, SNOMED CT View
Bleeding - Other SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ACC NCDR, SNOMED CT View
Bleeding - Retroperitoneal SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications ACC NCDR, SNOMED CT View
Cardiac Arrest SYSTEMATIC_ASSESSMENT Cardiac disorders ACC NCDR, SNOMED CT View
Cardiac Tamponade SYSTEMATIC_ASSESSMENT Cardiac disorders ACC NCDR, SNOMED CT View
Cardiogenic Shock SYSTEMATIC_ASSESSMENT Cardiac disorders ACC NCDR, SNOMED CT View
Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders ACC NCDR, SNOMED CT View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders ACC NCDR, SNOMED CT View
Other Vascular Complications Requiring Treatment SYSTEMATIC_ASSESSMENT Vascular disorders ACC NCDR, SNOMED CT View
New Requirement for Dialysis SYSTEMATIC_ASSESSMENT Renal and urinary disorders ACC NCDR, SNOMED CT View
Stroke - Ischemic SYSTEMATIC_ASSESSMENT Nervous system disorders ACC NCDR, SNOMED CT View
Coronary Artery Perforation SYSTEMATIC_ASSESSMENT Cardiac disorders ACC NCDR, SNOMED CT View
Other Events(If Any):