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 @ 6:34 PM
Ignite Modification Date: 2025-12-25 @ 4:04 PM
NCT ID: NCT00666757
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00666757
Study Brief: A Study Comparing Duloxetine to Other Antidepressants in the Treatment of Severe Depression
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Duloxetine 30-120 mg orally daily for 12 weeks None None 4 372 277 372 View
Citalopram 20-40 mg orally daily for 12 weeks None None 2 157 112 157 View
Fluoxetine 20-80 mg orally daily for 12 weeks None None 1 57 47 57 View
Paroxetine 20-50 mg orally daily for 12 weeks None None 1 45 36 45 View
Sertraline 50-200 mg orally daily for 12 weeks None None 2 119 86 119 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Tibia fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA(11.0) View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA(11.0) View
Temporal lobe epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA(11.0) View
Post-traumatic stress disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA(11.0) View
Nephrolithiasis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA(11.0) View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA(11.0) View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA(11.0) View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA(11.0) View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA(11.0) View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA(11.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA(11.0) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA(11.0) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA(11.0) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA(11.0) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA(11.0) View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA(11.0) View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA(11.0) View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA(11.0) View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA(11.0) View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA(11.0) View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA(11.0) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA(11.0) View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA(11.0) View
Anorgasmia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA(11.0) View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA(11.0) View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA(11.0) View