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 @ 2:28 AM
Ignite Modification Date: 2025-12-26 @ 1:02 AM
NCT ID: NCT02489734
Description: In the PACU, any adverse events such as hypoxemia (defined as SpO2 \<92%), laryngospasm (defined as inability to ventilate despite maneuvers to relieve airway obstruction), bronchospasm (defined as wheezing on auscultation), respiratory obstruction (defined as chin lift, oral airway, or reintubation needed to avoid hypoxemia), or postoperative nausea and vomiting (PONV) were recorded by the same nurse.
Frequency Threshold: 0
Time Frame: Adverse events were assessed and recorded during the PACU, an average of 1 hour.
Study: NCT02489734
Study Brief: Post Extubation Delirium and End-tidal Sevoflurane Concentration
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Low Concentration (LC) In the LC group, the trachea was extubated as soon as cough or purposeful movement appeared when end-tidal sevoflurane concentration was less than 0.5%. Patients were excluded in this group if cough or purposeful movement appeared when end-tidal sevoflurane concentration was more than 0.5%. 0 None 0 39 3 39 View
High Concentration (HC) In the HC group, when end-tidal sevoflurane concentration was more than 0.5%, the trachea was extubated as soon as cough or purposeful movement appeared. If there was still no cough or purposeful movement when end-tidal sevoflurane concentration had decreased to 0.5%, the trachea was extubated at this concentration. 0 None 0 53 5 53 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
respiratory obstruction SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
postoperative nausea and vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
hypoxemia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
laryngospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
bronchospasm SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View