Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:42 AM
Ignite Modification Date: 2025-12-26 @ 1:21 AM
NCT ID: NCT03182933
Description: Any events that were deemed to be reportable events were discussed with the IRB
Frequency Threshold: 0
Time Frame: Up to 72 hours
Study: NCT03182933
Study Brief: Liposomal Bupivacaine Versus Standard Bupivacaine in the Adductor Canal for Total Knee Arthroplasty
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Liposomal Bupivacaine Group 20ml 1.33% liposomal bupivacaine administered in adductor canal (a type of peripheral nerve block) Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization 10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1 0 None 0 31 1 31 View
Standard Bupivacaine Group 20ml 0.5% standard bupivacaine in adductor canal (a type of peripheral nerve block) Peripheral Nerve Blockade: Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization 10 meter walk test on post-operative day 1: Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist In person and over the phone questionnaire: Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores Force transduction of quadriceps strength: Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1 0 None 0 32 0 32 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Falls SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Fall View