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 @ 3:01 PM
Ignite Modification Date: 2025-12-25 @ 1:25 PM
NCT ID: NCT00974259
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00974259
Study Brief: Brain Tissue Oxygen Monitoring in Traumatic Brain Injury (TBI)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
pBrO2 and ICP Management Treatment protocol based on pBrO2 and ICP values. Management protocol based on pBrO2 and ICP values.: For patients who experience falls in pBrO2 below 20 mm Hg, a hierarchical treatment algorithm will be instituted, adapted from published recommendations49. In principle, episodes requiring therapy will fall into one of 4 scenarios (scenario A, B, C, and D, defined in figure 7), which will require different management strategies. The treatment protocol depends on which type of episode is being treated. Treatment is triggered by abnormalities in either ICP (\> 20 mm Hg) or pBrO2 (\< 20 mm Hg) are noted. Elevations in ICP above 20 mm Hg or decline in pBrO2 below 20 mm Hg for more than 5 minutes will trigger a treatment intervention. Treatment is directed to an episode. Patients may start in one type of episode and move to another. Therapy will depend on which type of episode they are in at any given time. 13 None 27 57 48 57 View
ICP Management Treatment protocol based on ICP values only. Management protocol based on ICP values only.: For the patients randomized to ICP treatment alone, only Scenario A and Scenario B episodes are relevant. 18 None 34 62 55 62 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiovascular None Cardiac disorders None View
Pulmonary SYSTEMATIC_ASSESSMENT General disorders None View
Gastro-intestinal SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Neurological SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Other NON_SYSTEMATIC_ASSESSMENT General disorders None View