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 @ 4:37 PM
Ignite Modification Date: 2025-12-25 @ 2:27 PM
NCT ID: NCT03305666
Description: None
Frequency Threshold: 0
Time Frame: Adverse event data were collected throughout the participants' stay in the hospital or for 28 days, whichever length of time was the shorter duration.
Study: NCT03305666
Study Brief: Trial of Injected Liposomal Bupivacaine vs Bupivacaine Infusion After Surgical Stabilization of Rib Fractures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Bupivacaine Indwelling Catheter Bupivacaine indwelling OnQ pain pump catheter will be placed in the subscapular space at the time of surgery, at infusion of 12 ml/hr of 0.25% bupivacaine, and left in place for a maximum of 120 hours Bupivacaine indwelling catheter: Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op 0 None 0 16 3 16 View
Liposomal Bupivacaine Injection A single injection of liposomal bupivacaine: mixture of 20 mL liposomal bupivacaine, 20 mL 0.25% bupivacaine, and 10 mL sterile saline (50 mL total), will be delivered in the intercostal space during VATS (with a 178 mm, 22 gauge needle, at ribs 3-8). Liposomal bupivacaine injection: A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS 0 None 0 18 1 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hospital Readmission SYSTEMATIC_ASSESSMENT Social circumstances None View
Hospital Readmission SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
OR Takeback SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
ED Visit SYSTEMATIC_ASSESSMENT Social circumstances None View