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 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:55 PM
NCT ID: NCT00419094
Description: None
Frequency Threshold: 5
Time Frame: Up to 29 weeks
Study: NCT00419094
Study Brief: Conversion to Monotherapy Study With Keppra XR for Partial 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
Keppra XR 1000 mg/Day 1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily) None None 2 57 33 57 View
Keppra XR 2000 mg/Day 2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily) None None 12 171 87 171 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (9.0) View
haemorrhoidal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
pulmonary tuberculosis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (9.0) View
intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (9.0) View
lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA (9.0) View
convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
status epilepticus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
acute psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (9.0) View
thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (9.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (9.0) View
abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
irritablility NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (9.0) View
somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View