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 @ 12:59 PM
Ignite Modification Date: 2025-12-25 @ 12:19 PM
NCT ID: NCT00812461
Description: None
Frequency Threshold: 5
Time Frame: Serious Adverse Events: 24 weeks, a 4-week run-out period, and a safety follow-up (visit/telephone call) scheduled for 4 weeks after completion of the study or after withdrawal from the study. Other Adverse Events: 24 weeks and a 4-week run-out period.
Study: NCT00812461
Study Brief: Efficacy of Nalmefene in Patients With Alcohol Dependence
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 as-needed use, tablets, orally, 6 months None None 14 337 102 337 View
Nalmefene 18.06 mg as-needed use, tablets, orally, 6 months None None 7 341 157 341 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders Meddra 13.0 View
Pancreatitis acute NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 13.0 View
Rectal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 13.0 View
Sudden death NON_SYSTEMATIC_ASSESSMENT General disorders Meddra 13.0 View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 13.0 View
Pyothorax NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 13.0 View
Subcutaneous abscess NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 13.0 View
Accidental overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Alcohol poisoning NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Drug toxicity NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Fibula fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Intentional overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Tendon rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Tibia fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Meddra 13.0 View
Bile duct cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meddra 13.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.0 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.0 View
Subarachnoid haemorrhage NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.0 View
Alcoholism NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Meddra 13.0 View
Suicidal behaviour NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Meddra 13.0 View
Arteritis NON_SYSTEMATIC_ASSESSMENT Vascular disorders Meddra 13.0 View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders Meddra 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 13.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 13.0 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Meddra 13.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations Meddra 13.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Meddra 13.0 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Meddra 13.0 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders Meddra 13.0 View