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 @ 6:43 PM
Ignite Modification Date: 2025-12-25 @ 4:14 PM
NCT ID: NCT01715857
Description: Spontaneous adverse events (AEs) were also to be collected from the time the physician obtained the participant's informed consent until 30 days following treatment (total of approximately 31 days); there were no spontaneously reported AEs from the registry.
Frequency Threshold: 0
Time Frame: All serious adverse events (SAEs) were required to be collected in the registry from the time the physician obtained the participant's informed consent until 30 days following treatment (approximately 31 days).
Study: NCT01715857
Study Brief: Clinical Practice of Inhalation Anesthesia With Sevoflurane in China
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Chinese Patients Requiring Surgery With Sevoflurane Anesthesia Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China None None 0 4004 0 4004 View
Serious Events(If Any):
Other Events(If Any):