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 @ 3:27 PM
Ignite Modification Date: 2025-12-25 @ 1:43 PM
NCT ID: NCT04274192
Description: 0 subjects were enrolled in the "continuous HFNC" arm, therefore 0 were at risk for SAEs, All-cause mortality, or Other AEs
Frequency Threshold: 0
Time Frame: Until the end of the treatment, approximately 1 day per subject
Study: NCT04274192
Study Brief: Effect of Synchronized vs. Continuous HFNC Using NAVA on WOB in Infants With BPD
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Synchronized HFNC First Subjects will first receive HFNC synchronized to his/her own efforts via NAVA at 6 LPM followed by continuous HFNC at 6 LPM and then HFNC synchronized to his/her own efforts via NAVA at 8 LPM followed by continuous HFNC at 8 LPM 0 None 0 1 1 1 View
Continuous HFNC First Subjects will first receive continuous HFNC at 6 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 6 LPM and then continuous HFNC at 8 LPM followed by HFNC synchronized to his/her own efforts via NAVA at 8 LPM. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Study team error SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View