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 @ 7:56 PM
Ignite Modification Date: 2025-12-25 @ 5:31 PM
NCT ID: NCT04586504
Description: None
Frequency Threshold: 0
Time Frame: From time of intranasal midazolam administration until discharge from emergency department (approximately 120 minutes)
Study: NCT04586504
Study Brief: Dose-Finding Study of Intranasal Midazolam for Procedural Sedation in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
0.2 mg/kg Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.2 mg/kg. Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device. 0 None 0 19 0 19 View
0.3 mg/kg Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.3 mg/kg. Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device. 0 None 0 24 0 24 View
0.4 mg/kg Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.4 mg/kg. Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device. 0 None 0 29 2 29 View
0.5 mg/kg Children in a single urban pediatric emergency department (ED) randomized to receive IN midazolam at 0.5 mg/kg. Intranasal midazolam: 5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device. 0 None 0 29 0 29 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Paradoxical reaction SYSTEMATIC_ASSESSMENT Nervous system disorders None View