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 @ 2:17 AM
Ignite Modification Date: 2025-12-26 @ 12:48 AM
NCT ID: NCT00505934
Description: None
Frequency Threshold: 5
Time Frame: Up to 4 days
Study: NCT00505934
Study Brief: Open-label Study of Levetiracetam Intravenous Infusion in Children (1 Month-4 Years Old) With Epilepsy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Levetiracetam Intravenous 100 mg/mL, twice a day, maximum of 4 days Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:. * Ages ≥ 1 month to \< 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily); * Ages ≥ 6 months to \< 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily). For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows: * Ages ≥ 1 month to \< 6 months: 14 mg/kg/day (7 mg/kg twice daily). * Ages ≥ 6 months to \< 4 years: 20 mg/kg/day (10 mg/kg twice daily). None None 4 19 10 19 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
BRADYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (9.0) View
CARDIAC ARREST NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (9.0) View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
PNEUMONIA NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
ABDOMINAL SEPSIS NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
ELECTROCARDIOGRAM QT PROLONGED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (9.0) View
METABOLIC ACIDOSIS NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA (9.0) View
CONVULSION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
RESPIRATORY FAILURE NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
BRADYCARDIA NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (9.0) View
PUNCTURE SITE PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
MYOCLONIC EPILEPSY NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
RESTLESSNESS NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.0) View
NEURODERMATITIS NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (9.0) View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (9.0) View
EYE SWELLING NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (9.0) View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
IRRITABILITY NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
PAIN NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
PROCEDURAL PAIN NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (9.0) View
ELECTROENCEPHALOGRAM NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (9.0) View
SOMNOLENCE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
DROOLING NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
RHINORRHOEA NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (9.0) View
PETECHIAE NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (9.0) View