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 @ 4:30 PM
Ignite Modification Date: 2025-12-25 @ 2:23 PM
NCT ID: NCT01906866
Description: None
Frequency Threshold: 5
Time Frame: 104 weeks
Study: NCT01906866
Study Brief: Efficacy and Safety of Circadin® in the Treatment of Sleep Disturbances in Children With Neurodevelopment Disabilities
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Circadin 2/5/10 mg Double Blind Circadin 2/5/10 mg. Double blind period, active arm 0 None 0 60 51 60 View
Placebo Placebo arm 0 None 1 65 50 65 View
Circadin 2/5/10 mg Open Label Circadin 2/5/10 mg. Open-label period, active arm 0 None 6 95 80 95 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
SAE - Serious adverse event SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View
SAE -Serious adverse event SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
SAE -Serious adverse event SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Non-serious adverse events SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (18.0) View
Non-serious adverse events SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (18.0) View
Non-serious adverse events SYSTEMATIC_ASSESSMENT General disorders MedDRA (18.0) View
Non-serious adverse events SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (18.0) View
Non-serious adverse events SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (18.0) View
Non-serious adverse events SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (18.0) View
Non-serious adverse events SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (18.0) View