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 @ 11:58 PM
Ignite Modification Date: 2025-12-25 @ 9:55 PM
NCT ID: NCT02950558
Description: The protocol incorporated FDA adverse event definitions and Good Clinical Practices.
Frequency Threshold: 0
Time Frame: Subjects were contacted daily by phone for the first five days after surgery (which corresponded to the duration of ambulatory ropivacaine pump use for subjects in the experimental group). Medical chart records were reviewed for adverse events for 3 months following the surgery.
Study: NCT02950558
Study Brief: Anesthesia for Pain After Ankle Fracture Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Standard Care Single injection of ropivacaine immediately prior to surgery Ropivacaine: Single injection of ropivacaine immediately prior to surgery. 0 None 0 8 1 8 View
Ropivacaine Pump Single injection of ropivacaine immediately prior to surgery plus 5 day ambulatory popliteal nerve block. Ropivacaine: Single injection of ropivacaine immediately prior to surgery. Nerve block: insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump. 0 None 0 6 3 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
wound dehiscence NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
metalic taste around lips NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lightheadedness, nausea,headache NON_SYSTEMATIC_ASSESSMENT General disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View