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 @ 1:03 PM
Ignite Modification Date: 2025-12-25 @ 12:20 PM
NCT ID: NCT01428661
Description: One subject randomized to placebo did not take any study drug.
Frequency Threshold: 5
Time Frame: None
Study: NCT01428661
Study Brief: Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open Label Tasimelteon 20 mg capsules, PO daily for 52 weeks None None 6 339 74 339 View
Tasimelteon 20 mg tasimelteon capsules, PO daily for 8 weeks None None 2 254 38 254 View
Placebo Placebo capsules, PO daily for 8 weeks None None 3 252 53 252 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Blood Pressure Increased SYSTEMATIC_ASSESSMENT Investigations None View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Suicidal Ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
Staphylococcal Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatitis A SYSTEMATIC_ASSESSMENT Infections and infestations None View
Hepatitis B SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cervical Vertebral Fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Upper Respitory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations None View