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 @ 5:04 AM
Ignite Modification Date: 2025-12-26 @ 4:06 AM
NCT ID: NCT03035318
Description: Adverse events include excessive bleeding, infection, fracture nerve injury or need for revision surgery during the term of this study which is expected to be approximately 1 year from the time of surgery. All-cause mortality was not monitored/assessed for this study.
Frequency Threshold: 0
Time Frame: Approximately 1 year from the time of surgery.
Study: NCT03035318
Study Brief: Comparison of Glenoid Position Using SmartBones
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
DePuy Global® Anchor Peg Glenoid In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Glenoid Instrumentation to position the glenoid component. DePuy Global® Anchor Peg Glenoid Instrumentation: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation. 0 None 0 22 0 22 View
DePuy Instrumentation With SmartBone™ In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses DePuy Global® Anchor Peg Instrumentation with SmartBone™, to position the glenoid component. DePuy Global® Anchor Peg Instrumentation with SmartBone™: Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™. 0 None 0 21 0 21 View
IRI With SmartBone™ In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBone™, to position the glenoid component. IRI with SmartBone™: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™. 0 None 0 23 0 23 View
RTI With SmartBone™ In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses Real Time Instrumentation (RTI), with a SmartBone™, to position the glenoid component. RTI with SmartBone™: Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™. 0 None 0 21 0 21 View
IRI With SmartBase In the setting of Anatomic Total Shoulder Arthroplasty, this arm uses an Intelligent Reusable Instrumentation (IRI), with a SmartBase™, to position the glenoid component. IRI with SmartBase: Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase. 0 None 0 20 0 20 View
Serious Events(If Any):
Other Events(If Any):