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 @ 4:26 AM
Ignite Modification Date: 2025-12-26 @ 3:30 AM
NCT ID: NCT01390220
Description: Adverse events collected at each visit from participant and/or caregiver. TEAEs presented for TDP and CP separately. Due to the short systemic half-life of active (midazolam), TEAEs within 2 days after administration of first open-label USL261 5 mg dose presented for TDP, and within 2 days after administration of double-blind dose for CP.
Frequency Threshold: 5
Time Frame: Treatment emergent adverse events (TEAEs) collected from administration of first open-label dose of USL261 5 mg in Test Dose Phase (TDP) until completion of the final study visit or 7 days after the last administration of study drug, whichever was later. The duration of individual participant participation was variable as administration of the double-blind dose in the Comparative Phase (CP) was dependent on occurrence of a seizure cluster episode meeting trial criteria after randomization.
Study: NCT01390220
Study Brief: Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) 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 TDP Participants who received at least 1 open-label USL261 5 mg dose in Test Dose Phase (TDP) 0 None 2 292 78 292 View
USL261 CP, USL261 5 mg Only Participants completing TDP who received USL261 5 mg as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP) 0 None 0 91 17 91 View
USL261 CP, USL261 5 mg + 5 mg Participants completing TDP who received USL261 5 mg as randomized dose to treat a seizure cluster episode and received an open-label USL261 5 mg dose in the Comparative Phase (CP) 0 None 0 43 10 43 View
Placebo CP, Placebo Only Participants completing TDP who received Placebo as randomized dose to treat a seizure cluster episode in the Comparative Phase (CP) 0 None 0 26 3 26 View
Placebo CP, Placebo + USL261 5 mg Participants completing TDP who received Placebo as randomized dose to treat a seizure cluster episode and received an open-label USL261 5 mg dose in the Comparative Phase (CP) 0 None 1 41 7 41 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Seizure cluster SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Throat irritation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Lacrimation increased SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16.1 View
Product taste abnormal SYSTEMATIC_ASSESSMENT General disorders MedDRA 16.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16.1 View
Nasal discomfort SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16.1 View