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: 2025-12-24 @ 4:45 PM
Ignite Modification Date: 2025-12-25 @ 2:32 PM
NCT ID: NCT03336450
Description: None
Frequency Threshold: 0
Time Frame: From start of study drug administration up to follow-up (Day 8)
Study: NCT03336450
Study Brief: Study of Midazolam Hydrochloride Oromucosal Solution (MHOS/SHP615) in Pediatric Patients With Status Epilepticus (Convulsive) in the Community Setting
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SHP615 Participants received single fixed age-specific dose (6 months to less than \[\<\] 1 year received 2.5 milligrams \[mg\]; 1 to \< 5 years received 5 mg; 5 to \<10 years received 7.5 mg and 10 to \< 18 years received 10 mg) of midazolam hydrochloride oromucosal solution (MHOS)/SHP615 buccally by caregivers on Day 1. 0 None 1 3 2 3 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Febrile convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.0) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (20.0) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.0) View