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 @ 4:01 AM
Ignite Modification Date: 2025-12-26 @ 2:54 AM
NCT ID: NCT01751802
Description: Adverse events were collected for 3 double-blind periods
Frequency Threshold: 0
Time Frame: adverse events collected while participants were receiving ecopipam or placebo, either for 1 period (up to 6 weeks) or 2 periods (up to 12 weeks)
Study: NCT01751802
Study Brief: Ecopipam Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ecopipam Active substance being tested, orally once a day at bedtime Ecopipam: Antagonist of the dopamine D1 receptor None None 2 9 8 9 View
Placebo Inactive substance being tested, orally once a day at bedtime Placebo: Placebo for Ecopipam None None 1 6 2 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Dystonic crisis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Unusual somnolence NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Body temperature increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Bronchospasm NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Choking NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Compulsive lip biting NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Depressed mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dyskinesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dystonia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Eosinophilia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Lip injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mucosal inflammation NON_SYSTEMATIC_ASSESSMENT General disorders None View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Opisthotonus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oral candidiasis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Self injurious behaviour NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Transaminases increased NON_SYSTEMATIC_ASSESSMENT Investigations None View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View