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 @ 11:20 PM
Ignite Modification Date: 2025-12-25 @ 9:03 PM
NCT ID: NCT03923556
Description: Following definitions and processes described in protocol.
Frequency Threshold: 0
Time Frame: First 2 postoperative weeks
Study: NCT03923556
Study Brief: Sugammadex Versus Neostigmine for Reversal of Neuromuscular Blockade at the End of Kidney Transplantation 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
Sugammadex Sugammadex Sugammadex: Administration of Sugammadex intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 2-4 mg/kg) at the end of the surgery before tracheal extubation 0 None 4 42 2 42 View
Neostigmine Neostigmine Neostigmine: Administration of Neostigmine intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 0.03-0.07 mg/kg) at the end of the surgery before tracheal extubation 0 None 4 42 1 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Postoperative ureteral leak NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Reoperation for bleeding NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Kidney graft dysfunction NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Opioid-induced respiratory depression NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Respiratory symptoms requiring oxygen supplementation NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View