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 @ 5:34 PM
Ignite Modification Date: 2025-12-25 @ 3:06 PM
NCT ID: NCT04144868
Description: Serious adverse events are any untoward medical occurrence meeting any of the following criteria: (1) fatal (AEs causes death); (2) life-threatening; (3) causing or prolonging hospitalization; (4) disability or organ function impairment. In addition, other adverse events include pulmonary infections, acid-base imbalances, hematoma expansion, and other complications during and after interventions that are considered to be associated with the interventions.
Frequency Threshold: 0
Time Frame: From randomization to 90 days.
Study: NCT04144868
Study Brief: Normobaric Hyperoxia for Intracerebral Hemorrhage
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 Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission. Oxygen storage face masks and nasal catheter: Giving high-flow mask oxygen via oxygen storage face masks (100% O2, flow rate 8 L/min, 1 hour, four times daily, and 2 L/min via nasal catheter during intermittent periods, for 7 days) immediately at admission. 0 None 0 48 12 48 View
Control Group Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days. Nasal catheter: Giving 2 L/min flow of 100% O2 via nasal catheter at admission for 24 hours daily for 7 days. 0 None 0 48 12 48 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hematoma Expansion NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pulmonary Infections NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acid-base imbalances NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View