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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:23 AM
NCT ID: NCT02304302
Description: The definition of adverse event and/or serious adverse event, used to collect adverse event information, does not differ from the clinicaltrials.gov definitions.
Frequency Threshold: 0
Time Frame: From the beginning to the end of treatment, i.e., 16-18 weeks
Study: NCT02304302
Study Brief: Down Syndrome Memantine Follow-up Study
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 Identically looking placebo capsules to memantine were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3. Placebo: Identically looking placebo capsules bid (after a four-week regimen designed to mimic standard dose titration protocol) 0 None 0 79 44 79 View
Memantine Memantine capsules were dispensed in a 66-day supply (56 days plus 10 extra days) by the study coordinator to participants receiving the placebo at the end of visits 2 and 3. Memantine: Encapsulated Memantine 10 mg bid (after four-week standard dose titration protocol) 0 None 0 81 32 81 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Mood changes or sadness SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Signs and symptoms of upper respiratory viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Transient dizziness SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Mood changes or irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Oppositional or aggressive behavior SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Headache SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Drowsiness SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Nausea or vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 10.0 View
Weakness or fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Insomnia SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Increase in thyroid-stimulating hormone levels SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 10.0 View
Urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 10.0 View
Increased self-talk SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Increased appetite SYSTEMATIC_ASSESSMENT General disorders MedDRA 10.0 View
Tonsillitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View
Visual hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 10.0 View
Herpes simplex flair-up SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 10.0 View