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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT03745092
Description: All of the participants were with NIHSS≤4 and mRS≤2. NBO was supplied with 8L/min for 45min between the two times EEG recordings. Short-term performance, low flow velocity and mild neurological disorders rendered our intervention enough safe for the participants. All of the participants were followed up for 4 months and seven of them were performed with NBO with 5L/min, 45 minutes each time, 3 times daily, they did not reported any adverse events.
Frequency Threshold: 0
Time Frame: 4 months
Study: NCT03745092
Study Brief: The Efficacy of Normobaric Oxygen on Chronic Cerebral Ischemia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NBO Group Between the two time 30min-EEG recordings, the patients in the NBO group would receive NBO (8L/min, via face mask) for 45min. normobaric oxygen: Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa). 0 None 0 26 0 26 View
Control Group Between the two time 30min-EEG recordings, the patients in the control group would have a rest (lying, sitting or walking) for 45min. room air: The patient had a rest with lying, sitting or walking, did not performed with NBO intervention. 0 None 0 23 0 23 View
Serious Events(If Any):
Other Events(If Any):