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 @ 7:56 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT00750204
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT00750204
Study Brief: Airway Pressure Release Ventilation in Acute Lung Injury
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
APRV Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude. APRV: APRV Protocol * Set FiO2 at 0.1 higher than the setting on conventional MV currently used * Tlow = 1.0 second (this setting shall remain unchanged throughout the trial). * Respiratory rate (RR) to equal 60-65% of RR on conventional MV. * Phigh = the inspiratory plateau pressure. Maximum Phigh = 30 cm H20. * Plow = 5 cm H2O. Adjust Plow to achieve pressure release volumes 5.5-6.5 ml/kg of PBW. * If release volumes on APRV are greater than desired, increase Plow by 2-4 cm H2O increments to a maximum of Plow = 12 cm H2O. If release volumes are larger than desired despite raising Plow to 12 cm H20, decrease Phigh in increments of 2-4 cm H20 to achieve desired release volumes (minimum Phigh = 12 cm H20). If release volumes on APRV still remain larger than desire 0 None 0 1 0 1 View
Conventional MV Patients will be randomized to either arm. After 24 hours they will crossover to the alternative arm of the study for an additional 24 hours. After a total of 48 hours (24 hours in each study arm) the study will conclude. Conventional MV: Low tidal-volume mechanical ventilation 0 None 0 1 0 1 View
Serious Events(If Any):
Other Events(If Any):