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 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT02430818
Description: None
Frequency Threshold: 0
Time Frame: Patients will be monitored for 60 minutes for adverse events from the study medication.
Study: NCT02430818
Study Brief: Comparing Ketamine and Morphine in the Treatment of Acute Fracture Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ketamine Ketamine is a dissociative agent that is thought to modulate pain by binding to NMDA receptors. Participants assigned to the ketamine arm will be given 0.4 mg/kg IV of ketamine (40 mg maximum). ketamine 0 None 0 7 1 7 View
Morphine Morphine is an opioid that acts on opioidergic receptors to modulate pain. Participants in the opioid arm will receive 0.1 mg/kg IV of morphine (10 mg maximum). morphine 0 None 0 6 1 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
emergence reaction NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View