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 @ 12:35 AM
Ignite Modification Date: 2025-12-25 @ 10:44 PM
NCT ID: NCT01720667
Description: Data not collected separately for each intervention
Frequency Threshold: 5
Time Frame: Up to 5 days after treatment
Study: NCT01720667
Study Brief: Efficacy of Intravenous Levetiracetam in Neonatal Seizures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Intravenous Phenobarbital Intravenous phenobarbital 20 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg PHB infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with LEV 40 mg/kg first. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance 1.5 mg/kg PHB mg/kg/dose given IV q8 hours continued for five days. 1 None 5 42 13 42 View
Intravenous Levetiracetam Intravenous levetiracetam 40 - 60 mg/kg loading dose. If electrographic seizures persisted or recurred 15 minutes following completion of the infusion, subjects received a further 20 mg/kg LEV infusion over 15 minutes. If electrographic seizures persisted or recurred 15 minutes following completion of the second infusion, the subject was then treated with PHB 20 mg/kg. Another dose of 20 mg/kg PHB given if seizures persist. Unresponsive subjects exit the study. All subjects received maintenance LEV 10 mg/kg/dose given IV q8 hours continued for five days. 2 None 1 64 12 64 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Heart Rate Abnormality SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Respiratory Abnormality SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Poor Feeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
New Medications SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Heart Rate Abnormailty SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
New Medical Problem SYSTEMATIC_ASSESSMENT General disorders None View
New Medications SYSTEMATIC_ASSESSMENT General disorders None View
Vasopressor Requirement SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Respiratory Abnormality SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Poor Feeding SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View