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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:57 AM
NCT ID: NCT04214834
Description: None
Frequency Threshold: 0.00
Time Frame: Randomization through 8-weeks post discharge
Study: NCT04214834
Study Brief: Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Rapid Wean Rapid Wean: 15% decrements from the stabilization dose of morphine/methadone 0 None 1 98 3 98 View
Slow Wean Slow Wean: 10% decrements from the stabilization dose of morphine/methadone 0 None 1 91 4 91 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Epidural hematoma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Skull fracture NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Inguinal hernia/repair NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Over-sedation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Respiratory disturbances NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View