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 @ 12:16 AM
Ignite Modification Date: 2025-12-25 @ 10:19 PM
NCT ID: NCT02336958
Description: None
Frequency Threshold: 0
Time Frame: during the intraoperative period
Study: NCT02336958
Study Brief: Ultrasound Guided Intermediate Cervical Plexus Block and Additional Perivascular Local Anesthetic Infiltration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Saline Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%. intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block. jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration. None None 0 20 13 20 View
Ropivacaine Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block. pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration. jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage. None None 1 20 17 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
definitive stroke SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
temporarily hoarseness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
temporarily dysphagia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cough SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Horner syndrome SYSTEMATIC_ASSESSMENT Nervous system disorders None View
temporarily paresis of the hypoglossal nerve SYSTEMATIC_ASSESSMENT Nervous system disorders None View