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 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT02432456
Description: All adverse events were reported and reviewed by the IRB at our insitution.
Frequency Threshold: 0
Time Frame: Data was collected for the duration of all participants hospitalizations. At time of discharge adverse event recording was stopped as patients were monitored throughout only their index stay defined up to 365 days.
Study: NCT02432456
Study Brief: Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Infusion Subjects in this arm received the institutional standard of care for rib fractures along with a placebo (NaCl) infusion. 0 None 0 75 15 75 View
Ketamine Infusion Subjects in this arm will receive the institutional standard of care for rib fractures along with a ketamine infusion at a rate of 2.5 mcg/kg/min dosed based on ideal body weight. 0 None 0 75 7 75 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sedation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View