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 @ 1:41 AM
Ignite Modification Date: 2025-12-25 @ 11:57 PM
NCT ID: NCT03730194
Description: Adverse events were reported to the DSMB per university protocol. AEs were monitored/assessed according to the intervention received in stage one or stage two. 1 participant had abdominal pain during the baseline week, unrelated to the intervention. 4 participants had mild skin irritation potentially due to wearing the wrist actigraph device (unrelated to intervention). All participants recovered prior to study ending. All-Cause Mortality was not monitored/assessed.
Frequency Threshold: 0
Time Frame: Adverse events were monitored by the Data Safety Monitoring Board at the University of Nebraska Medical Center in conjunction with IRB protocols. Adverse event data were collected over the 2 years of the study (2019-2021) from initial consent to end of the trials (approximately 9 weeks).
Study: NCT03730194
Study Brief: A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders
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 Only Participants in this arm will take 3 mg of melatonin 30 minutes before bedtime. Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime 0 None 0 27 3 27 View
Bedtime Bank Only Participants in this arm will utilize the Bedtime Bank, a behavioral sleep intervention. Bedtime Bank: The Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time. 0 None 0 26 2 26 View
Combination (Melatonin+Bedtime Bank) Participants in this arm will take 3 mg melatonin 30 minutes before bedtime and utilize the Bedtime Bank, a behavioral sleep intervention. Melatonin: Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime Bedtime Bank: The Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time. 0 None 0 13 0 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Mild Dermatitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View