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: 2025-12-25 @ 2:43 AM
Ignite Modification Date: 2025-12-26 @ 1:22 AM
NCT ID: NCT01543633
Description: The definition of adverse event and/or serious adverse event does not differ from the clinical trials.gov definitions. Note that the study was stopped if the blood pressure fell out of the range of 20% of the baseline values of end-tidal CO2, pulse oximetry levels, O2 saturation, and blood pressure. The study was also aborted if there is a problem with the placement of the intra-arterial or intravenous catheter.
Frequency Threshold: 0
Time Frame: 24 hours. The day after completion of the anesthesia portion of the study, a follow-up call will be made by the study subject's dedicated anesthesiologist to ensure that the study subject has fully recovered and has no health concerns or problems related to the study.
Study: NCT01543633
Study Brief: EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Study Arm Subjects recruited into this study will be required to undergo a base MRI scan of the brain. On a separate day propofol will be administered with concurrent EEG while subjects respond to stimuli. Propofol: Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press). 0 None 0 17 0 17 View
Serious Events(If Any):
Other Events(If Any):