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 @ 2:08 PM
Ignite Modification Date: 2025-12-25 @ 12:49 PM
NCT ID: NCT04229095
Description: Adverse events, both serious and other, were documented at all study visits by the Medical Assistant on the adverse event case report form.
Frequency Threshold: 0
Time Frame: Adverse event data was collected at all study visits, for any average duration of 3 weeks.
Study: NCT04229095
Study Brief: Medication Development in Alcoholism: Suvorexant Versus Placebo
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Belsomra,(Suvorexant) 20 mg single-dose administration given on an inpatient clinical research unit Suvorexant 20 mg: Single-dose administration of 20 mg suvorexant given on an inpatient clinical research unit 0 None 0 14 8 14 View
Placebo, (Sugar Pill) Placebo single-dose administration given on an inpatient clinical research unit Placebo oral tablet: Single-dose administration of placebo given on an inpatient clinical research unit 0 None 0 12 7 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Feeling cold SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Vivid dreams SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Mental fatigue SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View