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 @ 7:17 PM
Ignite Modification Date: 2025-12-25 @ 4:54 PM
NCT ID: NCT04268303
Description: Adverse Events: The Safety Population included all participants in the Randomized Population who received at least 1 dose of double-blind investigational product. One participant enrolled and randomized to the 120 μg group was enrolled a second time at a different site and randomized to the 180 μg group. The data from both enrollments (120 μg and 180 μg) were included in the safety analyses and counted separately in each treatment group; they were counted once when dose groups were combined.
Frequency Threshold: 3
Time Frame: 30 days
Study: NCT04268303
Study Brief: Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Sublingual placebo film Placebo Film: Placebo Film for BXCL501 0 None 0 126 19 126 View
120 Micrograms Sublingual film containing 120 Micrograms dexmedetomidine Sublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501) 0 None 0 129 51 129 View
180 Micrograms Sublingual film containing 180 Micrograms dexmedetomidine Sublingual film containing dexmedetomidine (BXCL501): Sublingual film containing dexmedetomidine (BXCL501) 0 None 0 126 47 126 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypoesthesia oral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Orthostatic hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Paresthesia oral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View