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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT01142193
Description: If a subject experienced more than 1 of a given AE, the subject is counted only once for that AE. If a subject experienced more than 1 AE in a system organ class (SOC), the subject is counted only once for that SOC.
Frequency Threshold: 5
Time Frame: Adverse events with onset after the start of study medication and up to 30 days after the last dose of study drug are reported.
Study: NCT01142193
Study Brief: Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset 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
USL255 Titration of 50 mg in weekly increments over 3 weeks to 200 mg None None 2 124 35 124 View
Placebo Placebo None None 2 125 14 125 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Lobar Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 11.0 View
Physical Assault NON_SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 11.0 View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 11.0 View
Epileptic Psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 11.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View
Weight Decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (11.0) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (11.0) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (11.0) View