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 @ 2:18 AM
Ignite Modification Date: 2025-12-26 @ 12:49 AM
NCT ID: NCT01529034
Description: Adverse events collected at each visit from participant and/or caregiver. Due to intermittent treatment (qualifying seizure clusters), short systemic half-life of active (midazolam), and long participant duration, treatment emergent adverse event within 2 days after each treated seizure cluster are reported. Seizures were not considered adverse events unless worsening from underlying condition.
Frequency Threshold: 5
Time Frame: Original protocol - each participant 2 years from enrollment; Amended protocol - each participant open-ended from enrollment (up to 4 years or longer as approved by Health Authority where study being conducted). Actual individual participant duration 1.0 to 55.7 months.
Study: NCT01529034
Study Brief: Study to Evaluate the Long-term Safety and Tolerability of USL261 in Patients With Seizure Clusters
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
USL261 USL261 5 mg or USL261 5 mg + 5 mg for a treated seizure cluster episode 0 None 8 161 33 161 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Blood pressure increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16.1 View
Seizure cluster SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16.1 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Status epilepticus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View