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 @ 6:59 PM
Ignite Modification Date: 2025-12-25 @ 4:32 PM
NCT ID: NCT00631657
Description: AE data include AEs that occurred during the 6-month Treatment Period and the 7-day Discontinuation Period. AEs are reported for the study drug participants were receiving at the time the AE occurred.
Frequency Threshold: 5
Time Frame: Up to 30 days after last dose of study drug (up to 31 weeks)
Study: NCT00631657
Study Brief: A 6-Month Efficacy and Safety Study of Org 50081 in Adult Patients With Chronic Primary Insomnia (21106/P05701/MK-8265-002)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Esmirtazapine 4.5 mg Participants receive esmirtazapine 4.5 mg tablets, administered QD None None 8 342 183 342 View
Placebo Participants receive placebo tablets, administered QD None None 2 115 40 115 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.1 View
Retinal vein occlusion SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Sudden visual loss SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Infectious mononucleosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Cartilage injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Concussion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Facial bones fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Limb injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Road traffic accident SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Synovial rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.1 View
Nerve compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Bunion operation SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.1 View
Weight increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.1 View
Increased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.1 View