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 @ 9:15 PM
Ignite Modification Date: 2025-12-25 @ 7:04 PM
NCT ID: NCT00316004
Description: Serial blood sodium levels were drawn to monitor the effects of the hypertonic saline solutions; Serial head CT's (computed tomography) were done to monitor for increased intracranial hemorrhage; and incidents of seizures in the first 24 hours.
Frequency Threshold: 5
Time Frame: The time frame was from May 2006 through May 2009, which was 3 years
Study: NCT00316004
Study Brief: Hypertonic Resuscitation Following Severe 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
7.5% Hypertonic Saline/6% Dextran (HSD) 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. None None 69 359 0 359 View
7.5% Hypertonic Saline (HS) 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. None None 72 341 0 341 View
0.9% Normal Saline (NS) 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. None None 141 582 0 582 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypernatremia (sodium>160 mEq/L) requiring intervention SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Increased intracranial hemorrhage on serial head CT SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizures in the first 24 hours SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):