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 @ 4:05 AM
Ignite Modification Date: 2025-12-26 @ 3:00 AM
NCT ID: NCT03315702
Description: Samplings of 1 ml blood were performed twice per patient from peripheral venous catheter: the first just before endotracheal intubation and the second 3rd hour after that. Systematic monitoring, including electrocardiograph monitoring, brain electricity guardianship, blood gas，blood pressure, etc., was performed during surgery process. Patients responded normally with stable postoperative consciousness. No death, serious or other adverse events occurred during this process in surgical room.
Frequency Threshold: 0
Time Frame: 3 hours Explanation: The venous blood samples were collected twice for each patient that the first time was around the onset of the mechanical ventilation and the second was 3rd hour after the onset of the mechanical ventilation.
Study: NCT03315702
Study Brief: Effect of Mechanical Ventilation on Plasma Concentration Level of R-spondin Proteins
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control／Mechanical Ventilation Venous blood samples were collected twice for each patient，relatively before onset of mechanical ventilation and 3rd hour after mechanical ventilation. 0 None 0 52 0 52 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
0 SYSTEMATIC_ASSESSMENT General disorders None View