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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:38 AM
NCT ID: NCT01114360
Description: None
Frequency Threshold: 5
Time Frame: 4 weeks on each arm.
Study: NCT01114360
Study Brief: Melatonin and Nighttime Blood Pressure in African Americans-8 mg Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Melatonin African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \>115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo). None None 0 36 17 36 View
Placebo African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure \>115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin). None None 0 36 18 36 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders ICD-9 View
Daytime drowsiness SYSTEMATIC_ASSESSMENT General disorders ICD-9 View
Early Morning Wakening SYSTEMATIC_ASSESSMENT General disorders ICD-9 View
Dizziness SYSTEMATIC_ASSESSMENT General disorders ICD-9 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ICD-9 View
Weakness SYSTEMATIC_ASSESSMENT General disorders ICD-9 View
Blurred vision SYSTEMATIC_ASSESSMENT Eye disorders ICD-9 View
Heart palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders ICD-9 View