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 @ 2:30 AM
Ignite Modification Date: 2025-12-26 @ 1:05 AM
NCT ID: NCT00386334
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT00386334
Study Brief: A Long-Term Safety and Efficacy Study of Eszopiclone in Elderly With Primary Chronic Insomnia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Placebo tablets None None 2 None 61 None View
Eszopiclone Eszopiclone 2 mg tablets None None 4 None 86 None View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Appendicitis Perforated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.1 View
Cholecystisis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 10.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Completed Suicide SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Stress Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.1 View
Rectocele SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 10.1 View
Arteriosclerosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 10.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MeDRA 10.1 View
Stomach Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA10.1 View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA10.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA10.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA10.1 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA10.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA10.1 View
Influenza SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Upper Respiratory Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.1 View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 10.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 10.1 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Pharyngolaryngeal Pain SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 10.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 10.1 View