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 @ 4:14 AM
Ignite Modification Date: 2025-12-26 @ 3:13 AM
NCT ID: NCT00107120
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00107120
Study Brief: The Safety and Efficacy of Escitalopram in Pediatric 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
Escitalopram Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability. None None 4 155 121 155 View
Placebo Once daily oral administration of placebo tablets None None 2 157 118 157 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inflicted Injury NON_SYSTEMATIC_ASSESSMENT General disorders WHOART v.1998/04 View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHOART v.1998/04 View
Suicidal Tendency NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHOART v.1998/04 View
Depression Aggravated NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHOART v.1998/04 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders WHOART v.1998/04 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders WHOART v.1998/04 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHOART v.1998/04 View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHOART v.1998/04 View
Inflicted Injury NON_SYSTEMATIC_ASSESSMENT General disorders WHOART v.1998/04 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHOART v.1998/04 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders WHOART v.1998/04 View
Influenza-like Symptoms NON_SYSTEMATIC_ASSESSMENT General disorders WHOART v.1998/04 View
Rhinitis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHOART v.1998/04 View
Menstrual Cramps NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders WHOART v.1998/04 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHOART v.1998/04 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders WHOART v.1998/04 View
Upper Respiratory Tract Infections NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders WHOART v.1998/04 View